Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The central goal of this randomized, controlled pilot study is to examine the feasibility, acceptability, and preliminary effects of an educational intervention (called "Starting the Conversation"; STC) on patient communication about sexual health in gynecologic cancer and other patient health outcomes. Approximately 30 women with a diagnosis of gynecologic cancer will be randomized to either participate in either the Starting the Conversation (STC) condition, consisting of an educational video, workbook, and list of resources on sexual and menopausal health, or to a control condition offering the resource guide only. Patients will be asked to review intervention materials prior to their next clinic visit with their gynecologic 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starting the Conversation | Experimental | Participants are asked to watch an educational video along with an accompanying workbook (called "Starting the Conversation"). Participants are also asked to review a list of resources about sexual and menopausal health relevant to gynecologic cancer. |
|
| Sexual and Menopausal Health Resources Only | Active Comparator | Participants are given the list of resources about sexual and menopausal health only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Starting the Conversation | Behavioral | The Starting the Conversation intervention consists of a brief educational video and accompanying workbook with activities to help prepare patients to discuss sexual and menopausal types of health concerns effectively with gynecologic cancer providers, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. In addition, participants receive a list of sexual and menopausal resources. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Enrollment | Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation | Baseline |
| Feasibility - Retention | Number of enrolled participants that complete the final study survey. | 2 months |
| Feasibility - Intervention Completion | Number of participants randomized to receive the Starting the Conversation intervention who report having engaged at least somewhat with the video and/or accompanying workbook. | 2 weeks |
| Acceptability | The number of participants randomized to receive the Starting the Conversation intervention who endorse at least 6 of 8 core components of the Starting the Conversation Intervention (defined as satisfaction with the intervention, informativeness of the intervention, helpfulness of the intervention, relevance of the intervention, ease of participation, approval of the intervention format, likelihood of recommending the intervention to others, and perceived importance of the intervention for people with gynecologic cancer). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Efficacy - Post-Intervention | Patients' confidence that they can discuss sexual concerns with their provider and ask their provider about sexual concerns. Scale ranges from 0-10, with higher scores indicating higher self-efficacy. Means will be reported. | 2 weeks |
| Self-Efficacy - 2-Month Follow Up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Starting the Conversation | Participants are asked to watch an educational video along with an accompanying workbook (called "Starting the Conversation"). Participants are also asked to review a list of resources about sexual and menopausal health relevant to gynecologic cancer. Starting the Conversation: The Starting the Conversation intervention consists of a brief educational video and accompanying workbook with activities to help prepare patients to discuss sexual and menopausal types of health concerns effectively with gynecologic cancer providers, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. In addition, participants receive a list of sexual and menopausal resources. Sexual and Menopausal Health Resources Only: A list of resources on sexual/menopausal health both within and outside the institution, including websites. |
| FG001 | Sexual and Menopausal Health Resources Only | Participants are given the list of resources about sexual and menopausal health only. Sexual and Menopausal Health Resources Only: A list of resources on sexual/menopausal health both within and outside the institution, including websites. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Starting the Conversation | Participants are asked to watch an educational video along with an accompanying workbook (called "Starting the Conversation"). Participants are also asked to review a list of resources about sexual and menopausal health relevant to gynecologic cancer. Starting the Conversation: The Starting the Conversation intervention consists of a brief educational video and accompanying workbook with activities to help prepare patients to discuss sexual and menopausal types of health concerns effectively with gynecologic cancer providers, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. In addition, participants receive a list of sexual and menopausal resources. Sexual and Menopausal Health Resources Only: A list of resources on sexual/menopausal health both within and outside the institution, including websites. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Feasibility - Enrollment | Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation | Posted | Count of Participants | Participants | Baseline |
|
|
Adverse event data were collected throughout study participation (2 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Starting the Conversation | Participants are asked to watch an educational video along with an accompanying workbook (called "Starting the Conversation"). Participants are also asked to review a list of resources about sexual and menopausal health relevant to gynecologic cancer. Starting the Conversation: The Starting the Conversation intervention consists of a brief educational video and accompanying workbook with activities to help prepare patients to discuss sexual and menopausal types of health concerns effectively with gynecologic cancer providers, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. In addition, participants receive a list of sexual and menopausal resources. Sexual and Menopausal Health Resources Only: A list of resources on sexual/menopausal health both within and outside the institution, including websites. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Reese, Associate Professor | Fox Chase Cancer Center | 215-214-3223 | Jennifer.Reese@fccc.edu |
Not provided
| 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 | Jan 20, 2022 | May 13, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012723 | Sex |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sexual and Menopausal Health Resources Only | Behavioral | A list of resources on sexual/menopausal health both within and outside the institution, including websites. |
|
Patients' confidence that they can discuss sexual concerns with their provider and ask their provider about sexual concerns. Scale ranges from 0-10, with higher scores indicating higher self-efficacy. Means will be reported. |
| 2 months |
| Clinical Communication - Discussion of Sexual Health | Number of patients who discuss sexual health concerns in a clinic visit. | 2 weeks |
| Clinical Communication - Raising Topic of Sexual Health | Number of patients who raise the topic of sexual health concerns in a clinic visit. | 2 weeks |
| Clinical Communication - Asking a Question About Sexual Health | Number of patients who ask a question about sexual health concerns in a clinic visit. | 2 weeks |
| Change in Sexual Function | Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time. | baseline to 2 months |
| Sexual Activity | A single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days. Percent reporting sexual activity is reported. | 2 months |
| Psychological Distress - 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. Means will be reported. | 2 months |
| Psychological Distress - 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. Means will be reported. | 2 months |
| BG001 | Sexual and Menopausal Health Resources Only | Participants are given the list of resources about sexual and menopausal health only. Sexual and Menopausal Health Resources Only: A list of resources on sexual/menopausal health both within and outside the institution, including websites. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Partnered Status | Count of Participants | Participants |
|
| Disease Site | Count of Participants | Participants |
|
| Disease Stage | Disease stage is based on tumor size, lymph node involvement, and presence of distant metastatic disease. Stages I-II are lower stage/better prognosis and stage IV is metastatic/worst prognosis. | Count of Participants | Participants |
|
| Primary Surgery | Count of Participants | Participants |
|
| Chemotherapy Received | Count of Participants | Participants |
|
| Radiation Therapy Received | Count of Participants | Participants |
|
| Immunotherapy Received | Count of Participants | Participants |
|
| Hormonal Therapy Received | Count of Participants | Participants |
|
|
| Primary | Feasibility - Retention | Number of enrolled participants that complete the final study survey. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Primary | Feasibility - Intervention Completion | Number of participants randomized to receive the Starting the Conversation intervention who report having engaged at least somewhat with the video and/or accompanying workbook. | Only Starting the Conversation participants were asked about engagement with materials. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Primary | Acceptability | The number of participants randomized to receive the Starting the Conversation intervention who endorse at least 6 of 8 core components of the Starting the Conversation Intervention (defined as satisfaction with the intervention, informativeness of the intervention, helpfulness of the intervention, relevance of the intervention, ease of participation, approval of the intervention format, likelihood of recommending the intervention to others, and perceived importance of the intervention for people with gynecologic cancer). | Acceptability only measured in Starting the Conversation participants. One Starting the Conversation participant did not return the 2 week follow-up survey which measured acceptability. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Self-Efficacy - Post-Intervention | Patients' confidence that they can discuss sexual concerns with their provider and ask their provider about sexual concerns. Scale ranges from 0-10, with higher scores indicating higher self-efficacy. Means will be reported. | One Starting the Conversation participant did not complete the 2-week follow-up assessment | Posted | Mean | 95% Confidence Interval | units on a scale | 2 weeks |
|
|
|
| Secondary | Self-Efficacy - 2-Month Follow Up | Patients' confidence that they can discuss sexual concerns with their provider and ask their provider about sexual concerns. Scale ranges from 0-10, with higher scores indicating higher self-efficacy. Means will be reported. | One Starting the Conversation participant did not complete the 2-month follow-up assessment. | Posted | Mean | 95% Confidence Interval | units on a scale | 2 months |
|
|
|
| Secondary | Clinical Communication - Discussion of Sexual Health | Number of patients who discuss sexual health concerns in a clinic visit. | One Starting the Conversation participant did not complete the 2-week follow-up assessment. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Clinical Communication - Raising Topic of Sexual Health | Number of patients who raise the topic of sexual health concerns in a clinic visit. | One Starting the Conversation participant did not complete the 2-week follow-up assessment | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Clinical Communication - Asking a Question About Sexual Health | Number of patients who ask a question about sexual health concerns in a clinic visit. | One Starting the Conversation participant did not complete the 2-week follow-up assessment | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | Change in Sexual Function | Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time. | One Starting the Conversation participant did not complete the 2-month follow-up assessment, and 6 Starting the Conversation participants did not have sufficient data on the scale to calculate a change score. Four Resources Only participants did not have sufficient data on the scale to calculate a change score. | Posted | Mean | Standard Deviation | score on a scale | baseline to 2 months |
|
|
|
| Secondary | Sexual Activity | A single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days. Percent reporting sexual activity is reported. | One Starting the Conversation participant did not complete the 2-month follow-up assessment. | Posted | Count of Participants | Participants | 2 months |
|
|
|
| Secondary | Psychological Distress - 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. Means will be reported. | One Starting the Conversation participant did not complete the 2-month follow-up assessment. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months |
|
|
|
| Secondary | Psychological Distress - 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. Means will be reported. | One Starting the Conversation participant did not complete the 2-month follow-up assessment. | Posted | Mean | 95% Confidence Interval | score on a scale | 2 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Sexual and Menopausal Health Resources Only | Participants are given the list of resources about sexual and menopausal health only. Sexual and Menopausal Health Resources Only: A list of resources on sexual/menopausal health both within and outside the institution, including websites. | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
Not provided
Not provided