Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/27/2018 |
| Start Date: | October 27, 2015 |
| End Date: | September 29, 2017 |
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.
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.
Inclusion Criteria:
1. Female
2. Age > 21 years
3. Has diagnosis of non-recurrent stage I-III breast cancer
4. Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5
years ago (current use of endocrine therapy is acceptable)
5. Has a partner or spouse who is > 21
6. Lives with a romantic partner > 6 months
7. Score of > 3 on Patient Care Monitor Sexual Concerns screening item
8. No hearing impairment in patient or partner
Exclusion Criteria:
1. Not able to speak English, as stated in medical record or as observed by study team
member
2. ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical
record
3. 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.
4. Past history of any cancer other than non-melanoma skin cancer
5. Currently participating in couple/marital therapy
6. Currently pregnant
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