Clinical trial NCT02721147: Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
Official title: Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-29
Enrollment: 89
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Treatment as Measured Through Study Accrual
timeFrame: Up to 8 weeks
measure: Feasibility of the Treatment as Measured Through Study Attrition
timeFrame: Up to 8 weeks
measure: Feasibility of the Treatment as Measured Through Session Completion by Participant
timeFrame: Up to 8 weeks
measure: Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
timeFrame: Baseline to up to 8 weeks
measure: Change in Sexual Function Measured Using the International Index of Erectile Function
timeFrame: Baseline to up to 8 weeks
measure: Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
timeFrame: Baseline to up to 8 weeks
measure: Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
timeFrame: Baseline to up to 8 weeks
measure: Change in Beliefs (Self-efficacy)
timeFrame: Baseline to up to 8 weeks
measure: Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
timeFrame: Baseline to up to 8 weeks
measure: Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
timeFrame: Baseline to up to 8 weeks
measure: Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
timeFrame: Baseline to up to 8 weeks
measure: Change in Body Image Distress Measured Using the Body Image Scale
timeFrame: Baseline to up to 8 weeks
measure: Change in Depression Measured Using the Patient Health Questionnaire-9 Item
timeFrame: Baseline to up to 8 weeks
measure: Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
timeFrame: Baseline to up to 8 weeks
measure: Change in Cancer-related Distress Using the Impact of Events Scale-Revised
timeFrame: Baseline to up to 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: