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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA222124-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The objective of the proposed study is to evaluate an Intimacy Enhancement (IE) intervention in 120 female early stage breast cancer survivors reporting sexual concerns and their intimate partners (240 total participants). Couples will be randomized 1:1 to receive either the IE intervention or to an information and support condition (Living Healthy Together). The investigators will evaluate intervention effects on patient and partner sexual, relationship, and psychological outcomes.
Over half of breast cancer survivors experience sexual concerns resulting from physical changes due to breast surgery, chemotherapy, and hormonal therapies; emotional changes; and relationship difficulties. In contrast with many aspects of quality of life (QOL) that tend to improve over time for breast cancer survivors, sexual concerns often persist for years. As a result, many breast cancer survivors and their partners may wish to resume a satisfying intimate relationship after treatment ends but encounter difficulties in doing so. Sexual concerns often go unaddressed, can lead to clinically significant psychological distress, and have a negative impact on survivors' relationships and quality of life. Thus, addressing sexual concerns and improving sexual function is of critical importance to the long-term adjustment of these survivors. Given the central role of the intimate relationship in breast cancer survivors' sexual experiences, a couple-based intervention that systematically involves the partner may be a highly effective approach for addressing these concerns and improving function. Yet randomized controlled trials evaluating the efficacy of a couple-based intervention targeting sexual function for breast cancer survivors are lacking. In this study, the investigators plan to evaluate a four-session telephone couple-based intervention that provides education and training in cognitive and behavioral skills to help couples cope with sexual concerns and enhance their intimate relationship, called Intimacy Enhancement (IE).
The specific aims of this study are (1) to evaluate whether the IE intervention will lead to a significantly greater increase in patient sexual function from pre-treatment to post-treatment and 3- and 6-month follow-ups compared to the LHT condition; (2) to evaluate whether the IE intervention will lead to significantly greater improvements in partner sexual function, patient sexual distress, patient/partner relationship intimacy/quality, and psychological distress from pre-treatment to post-treatment and at 3- and 6-month follow-ups, compared to the LHT condition; (3) to evaluate whether increases from pre- to post-treatment in patient sexual communication and self-efficacy for coping with sexual concerns mediate the beneficial effects of the IE intervention on patient sexual function at 3- and 6-month follow-ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intimacy Enhancement | Experimental | Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. |
|
| Living Healthy Together | Active Comparator | Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intimacy Enhancement | Behavioral | The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Reported Patient 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. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time. | Baseline up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Reported Partner Sexual Function | Partners' (male) self-reported sexual function will be measured using the 15-item International Index of Erectile Function (IIEF). Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning. Change in mean male partner IIEF score over time will be reported. Positive mean change scores indicate increase in sexual functioning. |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32051002 | Derived | Reese JB, Zimmaro LA, Lepore SJ, Sorice KA, Handorf E, Daly MB, Schover LR, Kashy D, Westbrook K, Porter LS. Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):173. doi: 10.1186/s13063-019-3975-2. |
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All participants receive one telephone intervention or the other (IE or LHT); due to this, randomization occurs after the first telephone session is already scheduled so as not to waste randomization slots on couples who have no intention of following through with sessions.
As such, participants may be "lost" prior to randomization if they complete consent/baseline but never schedule their first telephone session.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intimacy Enhancement | Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition. |
| FG001 | Living Healthy Together | Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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We present data separately for patients and partners, even though dyads were assigned to the same study arm, as our outcomes are patient- and partner-specific.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Intimacy Enhancement | Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition. |
| 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 | Change in Self-Reported Patient 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. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time. | Only patient participants' data was analyzed for this aim. Of 61 IE patients, one did not return the 6-week follow-up assessment. Of 59 LHT patients, 4 did not return the 6-week follow-up assessment | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
Adverse events were tracked over the course of study participation (6 months).
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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 | Intimacy Enhancement Patients | Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Self-reported distress | Psychiatric disorders | Systematic Assessment | Any report of thoughts of self harm/being better off dead on the Patient Health Questionnaire, given at all time points. |
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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 | May 14, 2024 | May 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Living Healthy Together | Behavioral | The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions. |
|
| Baseline up to 6 weeks |
| Change in Self-Reported Patient Sexual Distress | Patient sexual distress will be measured using the 13-item Female Sexual Distress Scale-Revised (FSDS-R). Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score over time will be reported. Negative mean change scores indicate decrease in sexual distress. | Baseline up to 6 weeks |
| Change in Patients' Self-Reported Relationship Intimacy | Patient self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy. | Baseline up to 6 weeks |
| Change in Partners' Self-Reported Relationship Intimacy | Partner self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy. | Baseline up to 6 weeks |
| Change in Patients' Self-Reported Relationship Quality | Patient self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality. | Baseline up to 6 weeks |
| Change in Partners' Self-Reported Relationship Quality | Partner self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality. | Baseline up to 6 weeks |
| Change in Patients' Self-Reported Anxiety | Patients' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety. | Baseline up to 6 weeks |
| Change in Partners' Self-Reported Anxiety | Partners' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety. | Baseline up to 6 weeks |
| Change in Patients' Self-Reported Depressive Symptoms | Patients' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression. | Baseline up to 6 weeks |
| Change in Partners' Self-Reported Depressive Symptoms | Partners' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression. | Baseline up to 6 weeks |
| BG001 | Patient Living Healthy Together | Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions. |
| BG002 | Partner Intimacy Enhancement | Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition. |
| BG003 | Partner Living Healthy Together | Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions. |
| BG004 | 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 |
|
| Level of Sexual Concerns | Level of sexual concerns for patients on a scale of 0-10, with 0 indicating no sexual concerns and 10 indicating severe sexual concerns. Measure administered to patients only. | Measure given to patient participants only. | Mean | Standard Deviation | units on a scale |
|
| Length of Relationship (years) | Measure given to patient participants only | Mean | Standard Deviation | years |
|
| Time Since Diagnosis (months) | Measure given to patient participants only | Mean | Standard Deviation | months |
|
| Time Since Treatment Completion (months) | Measure given to patient participants only | Mean | Standard Deviation | months |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Relationship Status | Measure given to patient participants only. One IE patient and one LHT patient did not respond to this item on the survey. | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Patient Clinical Tumor Stage | Clinical tumor stage reflects the estimated tumor size and/or amount of spread into nearby structures at diagnosis. Higher tumor stage (e.g., cT4) indicates a larger tumor or spread and is associated with worse outcomes. | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Surgery Received | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Radiotherapy Received | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Chemotherapy Received | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Immunotherapy Received | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Endocrine Therapy Received | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Ovarian Suppression therapy Received | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Currently Receiving Endocrine/Ovarian Suppression Therapy | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Gynecologic Surgeries | Data available for patient participants only | Count of Participants | Participants |
|
| Patient Menopausal Status | Data available for patient participants only | Count of Participants | Participants |
|
| OG001 | Living Healthy Together | Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions. |
|
|
| Secondary | Change in Self-Reported Partner Sexual Function | Partners' (male) self-reported sexual function will be measured using the 15-item International Index of Erectile Function (IIEF). Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning. Change in mean male partner IIEF score over time will be reported. Positive mean change scores indicate increase in sexual functioning. | Only male partner participants' data were included in this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 2 were female, 3 did not return the 6-week follow-up assessment, and 1 did not have sufficient data to calculate a change score. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| Secondary | Change in Self-Reported Patient Sexual Distress | Patient sexual distress will be measured using the 13-item Female Sexual Distress Scale-Revised (FSDS-R). Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score over time will be reported. Negative mean change scores indicate decrease in sexual distress. | Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| Secondary | Change in Patients' Self-Reported Relationship Intimacy | Patient self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy. | Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| Secondary | Change in Partners' Self-Reported Relationship Intimacy | Partner self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy. | Only partner participants' data were used for this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| Secondary | Change in Patients' Self-Reported Relationship Quality | Patient self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality. | Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| Secondary | Change in Partners' Self-Reported Relationship Quality | Partner self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality. | Only partner participants' data were used for this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| Secondary | Change in Patients' Self-Reported Anxiety | Patients' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety. | Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| Secondary | Change in Partners' Self-Reported Anxiety | Partners' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety. | Only partner participants' data were used for this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| Secondary | Change in Patients' Self-Reported Depressive Symptoms | Patients' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression. | Only patient participants' data were used for this analysis. Of 61 IE patients, one did not complete the 6-week follow-up assessment. Of 59 LHT patients, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
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|
| Secondary | Change in Partners' Self-Reported Depressive Symptoms | Partners' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression. | Only partner participants' data were used for this analysis. Of 61 IE partners, one did not complete the 6-week follow-up assessment. Of 59 LHT partners, 4 did not complete the 6-week follow-up assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to 6 weeks |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 3 |
| 61 |
| EG001 | Living Healthy Together Patients | Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions. | 0 | 59 | 0 | 59 | 6 | 59 |
| EG002 | Intimacy Enhancement Partners | Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy. Intimacy Enhancement: The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition. | 0 | 61 | 0 | 61 | 2 | 61 |
| EG003 | Living Healthy Together Partners | Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics. Living Healthy Together: The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions. | 0 | 59 | 0 | 59 | 4 | 59 |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| High school |
|
| Some college |
|
| College degree |
|
| Graduate school |
|
| Unemployed/on disability |
|
| Retired |
|
| Homosexual/lesbian/gay |
|
| Bisexual |
|
| cT3 |
|
| cT4 |
|
| Mastectomy without reconstruction |
|
| No gynecologic surgery |
|
| Peri-menopausal |
|