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OpenTrials
Completed

NCT Number: NCT04806724

Opening the Conversation Study

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Gynecologic Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon State University

Corvallis, Oregon, 97331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • American Cancer Society, Inc.

Registry information

Official study title

Opening the Conversation for Couples With Reproductive Health Concerns

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2021
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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