Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

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.

Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference.

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.

Opening the Conversation

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.

Side by Side

Jessica R Gorman, PhD, MPH

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.

Opening the Conversation Study

Opening the Conversation for Couples With Reproductive Health Concerns

Relationship concern domain of the Fertility Problem Inventory (FPI) scale. 10 items. Range 10-60. Higher score indicates more reproductive distress.

Sexual and relationship distress (SaRDS). 30 items. Range 1-30. Higher score indicates more sexual distress.

Dyadic Adjustment Scale (DAS-7). 7 items. Range 0- 36. Higher score indicates higher relationship quality.

Miller Social Intimacy Scale (MSIS). 17 items. Range 17-170. Higher score indicates higher levels of intimacy.

Female Sexual Function Index (FSFI).19 items. Range 2-36. Higher score indicates higher functioning.

International Index of Erectile Function (IIEF). 15 items. Range 1-75. Higher score indicates a higher level of sexual functioning.

Global Measure of Sexual Satisfaction (GMSEX). 5 items. Higher score indicates higher level of sexual satisfaction.

Patient Health Questionnaire (PHQ-8).8 items. Range 0 -24. Higher score indicates higher levels of depression.

PROMIS Global 10 v1.2. Raw scores (range 10-50) are translated to T scores following PROMIS guidelines. Higher score indicates better functioning.

SECSI. 10 items. Range 0-30. Higher score indicates higher self-efficacy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Opening the Conversation Study	NCT04806724	Breast Cancer Gynecologic Can...	Opening the Con... Side by Side	18 Years -	Oregon State University
Opening the Conversation Study	NCT04806724	Breast Cancer Gynecologic Can...	Opening the Con... Side by Side	18 Years -	Oregon State University

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