Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02721147
- Run by
- Fox Chase Cancer Center
- People needed
- 89
- Starts
- 2015-10-27
- Expected to finish
- 2017-09-29
- Last updated by the study team
- 2018-10-25
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female
- Age > 21 years
- Has diagnosis of non-recurrent stage I-III breast cancer
- Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Has a partner or spouse who is > 21
- Lives with a romantic partner > 6 months
- Score of > 3 on Patient Care Monitor Sexual Concerns screening item
- No hearing impairment in patient or partner
You may not qualify if…
- Not able to speak English, as stated in medical record or as observed by study team member
- ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
- Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
- Past history of any cancer other than non-melanoma skin cancer
- Currently participating in couple/marital therapy
- Currently pregnant
Where it is running
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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