NCT02721147

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Intimacy Enhancing Intervention	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.
BEHAVIORAL	Living Healthy Together	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.
BEHAVIORAL	Partner-Assisted Coping Skills Training	Receive couple-based intimacy enhancement intervention
BEHAVIORAL	Behavioral, Psychological or Informational Intervention	Receive educational information and support

Timeline

• Start date: 2015-10-27
• Primary completion: 2017-09-29
• Completion: 2017-09-29
• First posted: 2016-03-29
• Last updated: 2018-10-25
• Results posted: 2018-10-25

Locations

1 site across 1 country: United States