CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
Intimacy Enhancing Intervention +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02721147
NCT02721147N/ACompleted

Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer

Fox Chase Cancer Center·interventional·Posted Mar 29, 2016·Updated Oct 25, 2018

In Brief

A clinical study evaluating Intimacy Enhancing Intervention, Living Healthy Together, and 2 other interventions for Breast Cancer. Completed, enrolled 89 participants across 1 site.

Detailed Summary

The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 29, 2016
Enrollment StartOct 27, 2015
Primary CompletionSep 29, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.3 years ago

Interventions

Intimacy Enhancing Interventionbehavioral

Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.

Living Healthy Togetherbehavioral

Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.

Partner-Assisted Coping Skills Trainingbehavioral

Receive couple-based intimacy enhancement intervention

Behavioral, Psychological or Informational Interventionbehavioral

Receive educational information and support