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Breast CancerNCT04806724

Opening the Conversation Study

A study testing Opening the Conversation and Side by Side in people with Breast Cancer and Gynecologic Cancer, run by Oregon State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Gynecologic Cancer
What is being tested?
Opening the Conversation and Side by Side
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteUnited States
Study dates
1 Sep 2021to 5 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon State University

    Corvallis, Oregon, 97331

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Opening the Conversation, Side by Side
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opening the ConversationBehavioural

    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 SideBehavioural

    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.

Study groups in NCT04806724
Study groupRoleWhat they receive
Program #1ExperimentalParticipants 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.
Receives: Behavioral: Opening the Conversation
Program #2Active comparatorParticipants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference.
Receives: Behavioral: Side by Side

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 3 months post-intervention

  2. Change in sexual distress

    Sexual and relationship distress (SaRDS). 30 items. Range 0-180. Higher score indicates more sexual distress.

    Measured: Baseline to 3 months post-intervention

Secondary outcomes (8)

  1. Change in relationship quality

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

    Measured: Baseline to 3 months post-intervention

  2. Change in relationship Intimacy

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

    Measured: Baseline to 3 months post-intervention

  3. Change in sexual function (female)

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

    Measured: Baseline to 3 months post-intervention.

  4. 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.

    Measured: Baseline to 3 months post-intervention

  5. Change in global sexual satisfaction

    Global Measure of Sexual Satisfaction (GMSEX). 5 items. Range 5-35. Higher score indicates higher level of sexual satisfaction.

    Measured: Baseline to 3 months post-intervention

  6. Change in depressive symptoms

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

    Measured: Baseline to 3 months post-intervention

  7. 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.

    Measured: Baseline to 3 months post-intervention

  8. Change in self-efficacy to communicate about sex and intimacy (survivor only)

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

    Measured: Baseline to 3 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2021
  2. Study start1 Sep 2021
  3. Primary completion5 Aug 2025
  4. Study completion5 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04806724
Sponsor's protocol ID
7621; HE-2022-41
Status last verified
Feb 2026
First submitted
16 Mar 2021
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gorman JR, Choun S, Lyons KS, Acquati C, Harvey SM, Salsman JM, Flexner L, Koneru G, Hayes-Lattin B, Reese JB. Dyadic Latent Profiles of Sexual and Reproductive Distress in Young Adult Cancer Survivors and Their Partners: A Cross-Sectional Analysis. Psychooncology. 2026 Aug;35(8):e70587. doi: 10.1002/pon.70587.

    PubMed 42635443

  • 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.

    PubMed 36056413

Questions about this trial

What is this clinical trial studying?

A study testing Opening the Conversation and Side by Side in people with Breast Cancer and Gynecologic Cancer, run by Oregon State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in reproductive distress (time frame: Baseline to 3 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04806724, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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Opening the Conversation Study (NCT04806724) | AzTrials