Opening the Conversation Study

February 17, 2026 updated by: Jessica Gorman, Oregon State University

Opening the Conversation for Couples With Reproductive Health Concerns

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Corvallis, Oregon, United States, 97331
        • Oregon State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Program #1
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.
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.
Active Comparator: Program #2
Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in reproductive distress
Time Frame: Baseline to 3 months post-intervention
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
Time Frame: Baseline to 3 months post-intervention
Sexual and relationship distress (SaRDS). 30 items. Range 0-180. Higher score indicates more sexual distress.
Baseline to 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in relationship quality
Time Frame: Baseline to 3 months post-intervention
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
Time Frame: Baseline to 3 months post-intervention
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)
Time Frame: Baseline to 3 months post-intervention.
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)
Time Frame: Baseline to 3 months post-intervention
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 depressive symptoms
Time Frame: Baseline to 3 months post-intervention
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
Time Frame: Baseline to 3 months post-intervention
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)
Time Frame: Baseline to 3 months post-intervention
SECSI. 10 items. Range 0-30. Higher score indicates higher self-efficacy.
Baseline to 3 months post-intervention
Change in global sexual satisfaction
Time Frame: Baseline to 3 months post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon State University

Collaborators

American Cancer Society, Inc.

Investigators

  • Principal Investigator: Jessica R Gorman, PhD, MPH, Oregon State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

August 5, 2025

Study Completion (Actual)

August 5, 2025

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7621; HE-2022-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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