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| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
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Young adult survivors of breast and gynecologic cancer face a number of challenges, including interrupted life plans. As many as two-thirds of these young survivors experience negative effects of cancer and cancer treatment on their reproductive health, including sexual function and ability to have children. These are among the most distressing aspects of life after cancer for young survivors and their partners, and when left unaddressed, lead to poorer mental health and quality of life. Yet, surprisingly, evidence-based programs are not available to help young couples manage this aspect of life after cancer. In this study, we will adapt and evaluate an intervention designed to help young couples cope with and communicate about cancer-related reproductive and sexual health concerns.
The specific aims of the study are:
Aim 1 (Phase I). Systematically adapt an empirically supported couple-based skills training intervention to help young breast and gynecologic cancer (BGC) survivors and their partners jointly manage the reproductive and sexual health consequences of cancer.
Aim 2 (Phase II - Quantitative). Evaluate the efficacy of the intervention and hypothesized mediators by conducting a randomized trial. We will evaluate the efficacy of the newly adapted intervention, Opening the Conversation (OC), on survivors' and their partners' reproductive and sexual distress as well as the relationship, sexual, and psychosocial health outcomes. We will determine whether dyadic coping and communication mediate intervention effects on survivors' and partners' reproductive and sexual distress.
Aim 3 (Phase II - Qualitative). Evaluate couples' experiences within and across conditions to gain in-depth knowledge of intervention components that influence hypothesized mediators and outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program #1 | Experimental | Participants attend 5 sessions (1.5 hours each) consisting of education and skills training to address cancer-related reproductive and sexual health concerns. Sessions occur via videoconference. |
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| Program #2 | Active Comparator | Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opening the Conversation | Behavioral | The intervention includes 5 weekly sessions (1.5 hours each), plus participant educational materials, and is delivered to couples via videoconference by a trained interventionist. Participants are asked to complete home activities between sessions. Sessions focus on development of communication and coping skills, with a focus on reproductive and sexual health distress. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in reproductive distress | Relationship concern domain of the Fertility Problem Inventory (FPI) scale. 10 items. Range 10-60. Higher score indicates more reproductive distress. | Baseline to 3 months post-intervention |
| Change in sexual distress | Sexual and relationship distress (SaRDS). 30 items. Range 0-180. Higher score indicates more sexual distress. | Baseline to 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in relationship quality | Dyadic Adjustment Scale (DAS-7). 7 items. Range 0- 36. Higher score indicates higher relationship quality. | Baseline to 3 months post-intervention |
| Change in relationship Intimacy |
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Inclusion Criteria:
Cancer survivor participants:
Partner participants:
Exclusion Criteria:
-Cancer survivors and partners are excluded if either partner does not meet eligibility criteria. Both partners must enroll or the dyad will be excluded.
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| Name | Affiliation | Role |
|---|---|---|
| Jessica R Gorman, PhD, MPH | Oregon State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon State University | Corvallis | Oregon | 97331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36056413 | Derived | Gorman JR, Lyons KS, Harvey SM, Acquati C, Salsman JM, Kashy DA, Drizin JH, Smith E, Flexner LM, Hayes-Lattin B, Reese JB. Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples. Trials. 2022 Sep 2;23(1):730. doi: 10.1186/s13063-022-06665-3. |
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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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|
| Side by Side | Behavioral | The intervention includes 4 weekly sessions (1.5 hours each), plus participant educational materials, and is delivered to couples via videoconference by a trained interventionist. Participants are asked to complete home activities between sessions. Sessions focus on development of communication and coping skills, with a focus on general cancer-related distress. |
|
Miller Social Intimacy Scale (MSIS). 17 items. Range 17-170. Higher score indicates higher levels of intimacy.
| Baseline to 3 months post-intervention |
| Change in sexual function (female) | Female Sexual Function Index (FSFI).19 items. Range 2-36. Higher score indicates higher functioning. | Baseline to 3 months post-intervention. |
| Chang in sexual function (male) | International Index of Erectile Function (IIEF). 15 items. Range 1-75. Higher score indicates a higher level of sexual functioning. | Baseline to 3 months post-intervention |
| Change in global sexual satisfaction | Global Measure of Sexual Satisfaction (GMSEX). 5 items. Range 5-35. Higher score indicates higher level of sexual satisfaction. | Baseline to 3 months post-intervention |
| Change in depressive symptoms | Patient Health Questionnaire (PHQ-8).8 items. Range 0 -24. Higher score indicates higher levels of depression. | Baseline to 3 months post-intervention |
| Change in global health-related quality of life | PROMIS Global 10 v1.2. Raw scores (range 10-50) are translated to T scores following PROMIS guidelines. Higher score indicates better functioning. | Baseline to 3 months post-intervention |
| Change in self-efficacy to communicate about sex and intimacy (survivor only) | SECSI. 10 items. Range 0-30. Higher score indicates higher self-efficacy. | Baseline to 3 months post-intervention |
| D017437 |
| Skin and Connective Tissue Diseases |