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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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The goal of this study is to evaluate an educational video intervention (called Starting the Conversation) aimed to enhance breast cancer patients' beliefs about and communication with respect to sexual concerns. In the current study, 128 breast cancer outpatients will be randomized to either participate in the video intervention and to receive a resource guide addressing sexual and menopausal health or to receive the resource guide alone. Patients will be asked to participate in the video and/or read through the resource guide prior to their clinic visit with their breast cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being and health-related QOL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resources Only | Active Comparator | Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit. |
|
| Resources + Video | Experimental | Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit. |
|
| Clinician Arm | No Intervention | Clinicians were consented in order to have their clinic visits audio recorded. No outcomes data were collected from clinician participants. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Starting the Conversation Video | Behavioral | The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy. | 2 weeks |
| Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy. | 2 months |
| Self-Reported Outcome Expectancies for Sexual Health Communication | Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 2 weeks |
| Self-Reported Outcome Expectancies for Sexual Health Communication | Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment Rates (Feasibility) | Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study. | baseline |
| Retention Rates (Feasibility) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
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Participants complete consent and baseline survey before being assigned to a study group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Resources Only | Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit. Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic. |
| FG001 | Resources + Video | Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit. Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic. |
| FG002 | Clinician Arm | Clinicians were consented in order to have their clinic visits audio recorded. Outcomes data were not collected from clinician participants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Resources Only | Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit. Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline/outcomes data was not analyzed from clinician participants (N=9) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy. | All participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 weeks. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
Adverse event data were collected over a period of 2 months.
An adverse event is defined as a distress reaction during any study event, including survey completion and intervention participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resources Only | Patients will receive a list of resources on sexual and menopausal health in breast cancer. They will be asked to review the resources before their next clinic visit. Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Reese, Associate Professor | Fox Chase Cancer Center | 215-214-3223 | Jennifer.Reese@fccc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2020 | Dec 21, 2020 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2019 | Jan 14, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D003142 | Communication |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012723 | Sex |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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|
| Sexual and Menopausal Health Resources | Behavioral | Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic. |
|
| Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit | As coded from clinic visit audio, the number of patients who ask at least one question about sexual health. | 2 weeks |
| Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit | As coded from clinic visit audio, the number of patients who raise the topic of sexual health during their encounter (out of encounters where a sexual health discussion occurred). | 2 weeks |
Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment.
| 2 weeks |
| Retention Rates (Feasibility) | Retention rates, as measured by percentage of patients who remain on study for 2-month follow-up assessment. | 2 months |
| Intervention Acceptability | Acceptability of intervention, as measured through the item "Overall, how satisfied were you with this program?". Responses options include Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. Responses of "satisfied" or "very satisfied" indicate acceptability. Number of patients reporting acceptability and number of patients not reporting acceptability are presented. | 2 weeks |
| Sexual Activity | Sexual activity was measured by a single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days. | 2 months |
| Sexual Function | Sexual function was assessed using the Lubrication, Vaginal Discomfort, Satisfaction, and Interest domain scores from the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction scale (PROMIS SexFS) Brief Profile Version 2.0. Scores are converted to a T-score metric where a score of 50 equates to the mean of the U.S. population of sexually active adults (SD=10). Higher scores for all domains except Vaginal Discomfort signify better function. | 2 months |
| General Self-Efficacy for Communication With Provider | Patients' self-efficacy for communicating with provider generally, as measured through the Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5). The PEPPI-5 is a five-item scale that measures patient confidence in communicating with providers. Response options are on a scale from 1 (Not at All Confident) to 5 (Very Confident) and are summed for a total self-efficacy score (Range: 5-25). Higher scores indicate higher self-efficacy. | 2 months |
| Barriers to Communicating About Sexual Health | Patient barriers to communication about sexual health, as measured through a 13-item scale. Scale items cover potential reasons a patient might not want to discuss sexual health concerns with her provider (e.g., "I might become embarrassed"). Items are scored on a 1-5 scale where 1=Strongly Disagree and 5=Strongly Disagree. A total barrier score will be taken from this scale (Range: 13-65). Higher scores indicate more perceived barriers to communication. | 2 months |
| Self-Reported Anxiety | Patients self-reported anxiety, as measured through anxiety subscale of the Hospital Anxiety & Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety. | 2 months |
| Self-Reported Depression | Patients self-reported depression, as measured through depression subscale of the Hospital Anxiety & Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depression. | 2 months |
| Self-Reported Quality of Life | Quality of life, as measured through the Abbreviated Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) total score. The FACT-B contains 23 items about physical, functional, and emotional well-being in the context of breast cancer. Scale items are scored from 0 to 4. Summed scores run from 0 to 92, with higher scores indicating higher quality of life. | 2 months |
| Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider. The items about treatment side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment side effects and asking her provider about treatment side effects. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported. | 2 weeks |
| Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider. The items about treatment side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment side effects and asking her provider about treatment side effects. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported. | 2 months |
| Self-Reported Self-Efficacy for Communicating About About Menopausal Health | Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider. The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported. | 2 weeks |
| Self-Reported Self-Efficacy for Communicating About About Menopausal Health | Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider. The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported. | 2 months |
| Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | Five items assessed the belief that discussing treatment side effects with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 2 weeks |
| Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | Five items assessed the belief that discussing treatment side effects with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 2 months |
| Self-Reported Outcome Expectancies for Communication About Menopausal Health | Five items assessed the belief that discussing menopausal health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 2 weeks |
| Self-Reported Outcome Expectancies for Communication About Menopausal Health | Five items assessed the belief that discussing menopausal health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 2 months |
| BG001 | Resources + Video | Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit. Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic. |
| BG002 | Clinician Arm | Clinicians were consented in order to have their clinic visits audio recorded. Outcomes data was not collected from clinician participants. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Months Since Breast Cancer Diagnosis | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | months |
|
| Relationship Status | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Education Level | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Employment Status | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Sexual Orientation | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Menopausal Status | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Breast Cancer Stage | Breast cancer stage was assigned by their oncologist using AJCC 7th and 8th edition staging criteria, with stage I having the best prognosis and stage IV having the worst prognosis. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Surgery Received | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Chemotherapy Received | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Endocrine Therapy Received | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Ovarian Suppression Therapy Received | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Radiation Therapy Received | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Immunotherapy Received | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| Self-Efficacy for Communicating About Sexual Health Issues | Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | score on a scale |
|
| Outcome Expectancies for Communicating About Sexual Health Issues | Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | score on a scale |
|
| Sexual Function | Sexual function was assessed using the Lubrication, Vaginal Discomfort, Satisfaction, and Interest domain scores from the PROMIS SexFS Brief Profile Version 2.0. Higher scores for all domains except Vaginal Discomfort signify better function. Scores are converted to a T-score metric where a score of 50 equates to the mean of the U.S. population of sexually active adults (SD=10). | The sexual interest item was administered to all participants, and the lubrication, vaginal discomfort, and satisfaction items were only administered to participants who reported being sexually active. Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | t-score |
|
| General Self-Efficacy for Communication With Provider | Patients' self-efficacy for communicating with provider generally, as measured through the Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5). The PEPPI-5 is a five-item scale that measures patient confidence in communicating with providers. Response options are on a scale from 1 (Not at All Confident) to 5 (Very Confident) and are summed for a total self-efficacy score (Range: 5-25). Higher scores indicate higher self-efficacy. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | score on a scale |
|
| Barriers to Communicating About Sexual Health | Patient barriers to communication about sexual health, as measured through a 13-item scale. Scale items cover potential reasons a patient might not want to discuss sexual health concerns with her provider (e.g., "I might become embarrassed"). Items are scored on a 1-5 scale where 1=Strongly Disagree and 5=Strongly Disagree and are summed for a total Barrier score (Range: 13-65). Higher scores indicate more perceived barriers to communication. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | score on a scale |
|
| Patient Anxiety | Patients self-reported anxiety, as measured through anxiety subscale of the Hospital Anxiety & Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | score on a scale |
|
| Patient Depression | Patients self-reported depression, as measured through depression subscale of the Hospital Anxiety & Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depression. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | score on a scale |
|
| Quality of Life | Quality of life, as measured through the Abbreviated Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) total score. The FACT-B contains 23 items about physical, functional, and emotional well-being in the context of breast cancer. Scale items are scored from 0 to 4. Summed scores run from 0 to 92, with higher scores indicating higher quality of life. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Mean | Standard Deviation | score on a scale |
|
| Sexual Activity | Sexual activity was measured by a single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days. | Baseline/outcomes data was not analyzed from clinician participants (N=9) | Count of Participants | Participants |
|
| OG001 | Resources + Video | Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit. Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic. |
|
|
| Primary | Self-Reported Self-Efficacy for Communicating About Sexual Health Issues | Two items assessed patients' self-efficacy (confidence) for communicating with their breast cancer clinician about sexual health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options used an 11-point scale (0=not at all confident/not at all to 10=extremely confident/very much). Mean scores across the two items were used, ranging from 0-10. Higher scores indicate higher self-efficacy. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| Primary | Self-Reported Outcome Expectancies for Sexual Health Communication | Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | All participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 weeks. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
|
|
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| Primary | Self-Reported Outcome Expectancies for Sexual Health Communication | Five items assessed the belief that discussing sexual health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
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| Primary | Number of Patients Who Asked at Least One Question About Sexual Health at Their Clinic Visit | As coded from clinic visit audio, the number of patients who ask at least one question about sexual health. | 64/71 participants in the Resources Only arm and 63/73 participants in the Resources + Video arm had their clinic encounters audio recorded and coded. Common reasons why encounters were not recorded include scheduling issues (patient canceled/rescheduled her appointment or attended at a time when recorders were not available) and patient being seen by a non-participating provider (i.e., a provider that did not agree to have their visits audio recorded). | Posted | Count of Participants | Participants | 2 weeks |
|
|
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| Primary | Number of Patients Who Initiate Conversation About Sexual Health in Their Clinic Visit | As coded from clinic visit audio, the number of patients who raise the topic of sexual health during their encounter (out of encounters where a sexual health discussion occurred). | Encounters where the provider raised the topic of sexual health were excluded from this analysis, as it is not known whether the patient would have raised the topic had the provider not raised it first. | Posted | Count of Participants | Participants | 2 weeks |
|
|
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| Secondary | Recruitment Rates (Feasibility) | Recruitment rates, as measured by percentage of patients enrolled (i.e., baselined) out of eligible patients approached for the study. | 177 eligible candidates were approached for participation in the intervention trial. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | Retention Rates (Feasibility) | Retention rates, as measured by percentage of patients who remain on study for 2-week follow-up assessment. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Retention Rates (Feasibility) | Retention rates, as measured by percentage of patients who remain on study for 2-month follow-up assessment. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Secondary | Intervention Acceptability | Acceptability of intervention, as measured through the item "Overall, how satisfied were you with this program?". Responses options include Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. Responses of "satisfied" or "very satisfied" indicate acceptability. Number of patients reporting acceptability and number of patients not reporting acceptability are presented. | Participants who did not complete the intervention (i.e., reported not watching the vide) and did not complete the 2-week survey were not administered this item. 64/73 participants both completed the intervention and the 2-week follow-up survey. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Sexual Activity | Sexual activity was measured by a single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Secondary | Sexual Function | Sexual function was assessed using the Lubrication, Vaginal Discomfort, Satisfaction, and Interest domain scores from the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction scale (PROMIS SexFS) Brief Profile Version 2.0. Scores are converted to a T-score metric where a score of 50 equates to the mean of the U.S. population of sexually active adults (SD=10). Higher scores for all domains except Vaginal Discomfort signify better function. | 69/71 Resources Only and 71/73 Resources + Video participants completed the 2-month follow-up. Only participants who reported being sexually active in the past month were given the items regarding vaginal lubrication, vaginal discomfort, and sexual satisfaction (32/69 Resources Only patients and 50/71 Resources + Video patients). All participants were given the item on sexual interest. | Posted | Mean | Standard Deviation | t-score | 2 months |
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| Secondary | General Self-Efficacy for Communication With Provider | Patients' self-efficacy for communicating with provider generally, as measured through the Perceived Efficacy in Patient-Physician Interactions Scale (PEPPI-5). The PEPPI-5 is a five-item scale that measures patient confidence in communicating with providers. Response options are on a scale from 1 (Not at All Confident) to 5 (Very Confident) and are summed for a total self-efficacy score (Range: 5-25). Higher scores indicate higher self-efficacy. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Secondary | Barriers to Communicating About Sexual Health | Patient barriers to communication about sexual health, as measured through a 13-item scale. Scale items cover potential reasons a patient might not want to discuss sexual health concerns with her provider (e.g., "I might become embarrassed"). Items are scored on a 1-5 scale where 1=Strongly Disagree and 5=Strongly Disagree. A total barrier score will be taken from this scale (Range: 13-65). Higher scores indicate more perceived barriers to communication. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Secondary | Self-Reported Anxiety | Patients self-reported anxiety, as measured through anxiety subscale of the Hospital Anxiety & Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Secondary | Self-Reported Depression | Patients self-reported depression, as measured through depression subscale of the Hospital Anxiety & Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depression. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Secondary | Self-Reported Quality of Life | Quality of life, as measured through the Abbreviated Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) total score. The FACT-B contains 23 items about physical, functional, and emotional well-being in the context of breast cancer. Scale items are scored from 0 to 4. Summed scores run from 0 to 92, with higher scores indicating higher quality of life. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Secondary | Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider. The items about treatment side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment side effects and asking her provider about treatment side effects. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported. | All participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 weeks. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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| Secondary | Self-Reported Self-Efficacy for Communicating About About Treatment Side Effects | Patients' self-reported self-efficacy for communication about treatment side effects with their breast cancer provider. The items about treatment side effects consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about treatment side effects and asking her provider about treatment side effects. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Secondary | Self-Reported Self-Efficacy for Communicating About About Menopausal Health | Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider. The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported. | All participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 weeks. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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| Secondary | Self-Reported Self-Efficacy for Communicating About About Menopausal Health | Patients' self-reported self-efficacy for communication about menopausal health with their breast cancer provider. The items about menopausal health consist of 2 items within a larger 6-item scale which ask the patient how confident she is in talking to her provider about menopausal health and asking her provider about menopausal health. Response options range from 0 (not at all confident) to 10 (extremely confident). Mean scores will be reported. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Secondary | Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | Five items assessed the belief that discussing treatment side effects with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | All participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 weeks. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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| Secondary | Self-Reported Outcome Expectancies for Communication About Treatment Side Effects | Five items assessed the belief that discussing treatment side effects with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| Secondary | Self-Reported Outcome Expectancies for Communication About Menopausal Health | Five items assessed the belief that discussing menopausal health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | All participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 weeks. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks |
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| Secondary | Self-Reported Outcome Expectancies for Communication About Menopausal Health | Five items assessed the belief that discussing menopausal health with her breast cancer clinician would lead to positive outcomes (e.g., "find a solution to a problem"). Response options used an 11-point scale (0=not at all to 10=very much). Mean scores across the five items were used, ranging from 0-10. Higher scores indicate higher expectancies for positive outcomes. | 69/71 participants in the Resources Only arm and 71/73 participants in the Resources + Video arm completed this measure at 2 months. Two participants in the Resources + Video arm withdrew from the study before the 2-week assessment, and two participants in the Resources Only arm were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
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| 0 |
| 71 |
| 0 |
| 71 |
| 0 |
| 71 |
| EG001 | Resources + Video | Patients will receive a list of web resources on sexual and menopausal health in breast cancer. In addition to the resources, patients will be asked to view an online video called "Starting the Conversation" and to complete an accompanying workbook. Patients in this arm will be asked to review the resource list, watch the Starting the Conversation video, and complete the workbook before their next clinic visit. Starting the Conversation Video: The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. Sexual and Menopausal Health Resources: Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic. | 0 | 73 | 0 | 73 | 0 | 73 |
| EG002 | Clinician Arm | Clinicians were consented in order to have their clinic visits audio recorded. | 0 | 9 | 0 | 9 | 0 | 9 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Some college |
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| Completed college/graduate school |
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| Unemployed/disability/other |
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| Bisexual |
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| Stage III |
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| Stage IV |
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| Mastectomy without reconstruction |
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| No surgery |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Refused to answer |
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| Vaginal discomfort |
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| Sexual satisfaction |
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| Sexual interest |
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