Opening the Conversation Study

NCT04806724 | Completed

• 1 other identifier: 7621; HE-2022-41
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• Change in relationship quality

  Baseline to 3 months post-intervention

• Change in relationship Intimacy

  Baseline to 3 months post-intervention

• Change in sexual function (female)

  Baseline to 3 months post-intervention.

• Chang in sexual function (male)

  Baseline to 3 months post-intervention

• Change in global sexual satisfaction

  Baseline to 3 months post-intervention

Study Arms (2)

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.

Behavioral: Opening the Conversation

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.

Behavioral: Side by Side

Interventions

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.

Program #2

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.

Program #1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cancer survivors and partners are excluded if either partner does not meet eligibility criteria. Both partners must enroll or the dyad will be excluded.

Sponsors & Collaborators

• Oregon State University: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Related Publications (1)

• 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.

  PMID: 36056413 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jessica R Gorman, PhD, MPH

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: September 1, 2021
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)