Opening the Conversation Study

Breast Cancer Clinical Trial

Official title:

Opening the Conversation for Couples With Reproductive Health Concerns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806724
• Other study ID #: 7621
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Oregon State University
• Contact: Jessica R Gorman, PhD, MPH
• Phone: 541-737-2323
• Email: Jessica.Gorman[@]oregonstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Cancer survivor participants:

• Cancer diagnosis between ages 18-39 years
• Current age 18-44
• Cancer diagnosis 6 months-5 years prior to enrollment
• Diagnosed with breast and/or gynecologic cancer
• Cancer stage 1-4
• Ability to participate in a videoconference intervention
• Has committed partner willing to participate
• English speaking
• High speed internet access via smart phone, tablet and/or computer

Partner participants:

• Age 18 or older
• English speaking
• Ability to participate in a videoconference intervention
• High speed internet access via smart phone, tablet and/or computer 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.

Related Conditions & MeSH terms

• Breast Cancer
• Gynecologic Cancer

Intervention

Behavioral:
• Opening the Conversation
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.
• Side by Side
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.

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon State University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in sexual distress	Sexual and relationship distress (SaRDS). 30 items. Range 1-30. Higher score indicates more sexual distress.	Baseline to 3 months post-intervention
Secondary	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
Secondary	Change in relationship Intimacy	Miller Social Intimacy Scale (MSIS). 17 items. Range 17-170. Higher score indicates higher levels of intimacy.	Baseline to 3 months post-intervention
Secondary	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.
Secondary	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
Secondary	Change in global sexual satisfaction	Global Measure of Sexual Satisfaction (GMSEX). 5 items. Higher score indicates higher level of sexual satisfaction.	Baseline to 3 months post-intervention
Secondary	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
Secondary	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
Secondary	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