N/A
Completed N=89
Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
Source: ClinicalTrials.gov NCT02721147 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Feasibility of the Treatment as Measured Through Study Accrual — 62 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Treatment as Measured Through Study Accrual |
62 | — |
| PRIMARY Feasibility of the Treatment as Measured Through Study Attrition |
38; 18 | — |
| PRIMARY Feasibility of the Treatment as Measured Through Session Completion by Participant |
34; 16 | — |
| PRIMARY Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8) |
31.0; 26.5 | — |
| SECONDARY Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI) |
9.76; -0.38 | — |
| SECONDARY Change in Sexual Function Measured Using the International Index of Erectile Function |
5.26; -2.57 | — |
| SECONDARY Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items |
5.63; -0.86 | — |
| SECONDARY Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised |
-9.21; -1.44 | — |
| SECONDARY Change in Beliefs (Self-efficacy) |
18.51; 1.37 | — |
| SECONDARY Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale |
0.08; 0.20 | — |
| SECONDARY Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale |
6.77; 1.50 | — |
| SECONDARY Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item |
0.71; 1.28 | — |
| SECONDARY Change in Body Image Distress Measured Using the Body Image Scale |
-2.63; -1.78 | — |
| SECONDARY Change in Depression Measured Using the Patient Health Questionnaire-9 Item |
-1.95; 0.00 | — |
| SECONDARY Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item |
-1.74; 3.11 | — |
| SECONDARY Change in Cancer-related Distress Using the Impact of Events Scale-Revised |
-3.55; -0.94 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02721147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.