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Communication Intervention for Cancer-Related Reproductive Concerns

N/A

Recruiting

Led By Jessica R Gorman, PhD, MPH

Research Sponsored by Oregon State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current age 18-44

Cancer diagnosis between ages 18-39 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months post-intervention

Awards & highlights

Study Summary

This trial will adapt and evaluate an intervention to help young couples communicate about cancer-related reproductive and sexual health concerns, which can negatively affect mental health and quality of life.

Who is the study for?

This trial is for young adult survivors of breast or gynecologic cancer, aged 18-44, who were diagnosed between ages 18-39 and are within 6 months to 5 years post-diagnosis. Participants must have a committed partner over the age of 18 willing to join, speak English, and have high-speed internet for videoconferencing.Check my eligibility

What is being tested?

The 'Opening the Conversation' study tests an intervention aimed at helping young couples cope with reproductive and sexual health issues after cancer. It involves adapting an evidence-based program for these survivors and their partners to improve communication on these sensitive topics.See study design

What are the potential side effects?

Since this trial focuses on communication interventions rather than medical treatments, traditional physical side effects are not applicable. However, participants may experience emotional discomfort discussing intimate topics related to reproductive and sexual health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 44 years old.

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I was diagnosed with cancer between the ages of 18 and 39.

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My cancer is between stage 1 and stage 4.

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I am 18 years old or older.

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I was diagnosed with cancer between 6 months and 5 years ago.

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I have been diagnosed with breast or gynecologic cancer.

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I can join a video call.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in reproductive distress

Change in sexual distress

Secondary outcome measures

Chang in sexual function (male)

Change in depressive symptoms

Change in global health-related quality of life

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Program #1Experimental Treatment1 Intervention

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.

Group II: Program #2Active Control1 Intervention

Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,255 Total Patients Enrolled

32 Trials studying Breast Cancer

8,684 Patients Enrolled for Breast Cancer

Oregon State UniversityLead Sponsor

49 Previous Clinical Trials

8,181 Total Patients Enrolled

1 Trials studying Breast Cancer

28 Patients Enrolled for Breast Cancer

Jessica R Gorman, PhD, MPHPrincipal InvestigatorOregon State University

1 Previous Clinical Trials

28 Total Patients Enrolled

1 Trials studying Breast Cancer

28 Patients Enrolled for Breast Cancer

Media Library

Opening the Conversation Clinical Trial Eligibility Overview. Trial Name: NCT04806724 — N/A

Breast Cancer Research Study Groups: Program #2, Program #1

Breast Cancer Clinical Trial 2023: Opening the Conversation Highlights & Side Effects. Trial Name: NCT04806724 — N/A

Opening the Conversation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04806724 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to register with this clinical trial currently?

"Affirmative, the data on clinicaltrials.gov specifies that this study is still gathering participants for its trials. It was initially posted in September of 2021 and modified as recently as January 21st 2022. 200 people are being sought from one site to partake in the investigation."

Answered by AI

How many participants are currently partaking in the experiment?

"Affirmative, the data on clinicaltrials.gov confirms that this medical study is actively recruiting volunteers. It was first posted on September 1st 2021 and updated most recently on January 21st 2022. The experiment needs to enroll 200 patients from a single site."

Answered by AI

What outcome is the clinical trial designed to achieve?

"This clinical trial will assess the Change in Sexual Distress of participants at Baseline and 3 months after intervention. Secondary outcomes that are being evaluated include Chang in Sexual Function (Male) represented by International Index of Erectile Function, Change in Self-Efficacy to Communicate about Sex and Intimacy for Survivors as measured by SECSI, and a Miller Social Intimacy Scale determining changes in Relationship Intimacy."

Answered by AI

Recent research and studies

TrialsJournal

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

Gorman, Jessica R., Karen S. Lyons, S. Marie Harvey, Chiara Acquati, John M. Salsman, Deborah A. Kashy, Julia H. Drizin, et al.. 2022. “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. Springer Science and Business Media LLC. doi:10.1186/s13063-022-06665-3.

clinicaltrials.govStudy

Opening the Conversation Study

Jessica Gorman 2021. "Opening the Conversation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04806724.