N/A
Completed N=240
Coping Together After Breast Cancer
Source: ClinicalTrials.gov NCT03930797 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Change in Self-Reported Patient Sexual Function — 6.41; 0.90 score on a scale
Summary
The objective of the proposed study is to evaluate an Intimacy Enhancement (IE) intervention in 120 female early stage breast cancer survivors reporting sexual concerns and their intimate partners (240 total participants). Couples will be randomized 1:1 to receive either the IE intervention or to an information and support condition (Living Healthy Together). The investigators will evaluate intervention effects on patient and partner sexual, relationship, and psychological outcomes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Self-Reported Patient Sexual Function |
6.41; 0.90 | — |
| SECONDARY Change in Self-Reported Partner Sexual Function |
2.48; 1.00 | — |
| SECONDARY Change in Self-Reported Patient Sexual Distress |
-7.82; -4.40 | — |
| SECONDARY Change in Patients' Self-Reported Relationship Intimacy |
7.58; 5.85 | — |
| SECONDARY Change in Partners' Self-Reported Relationship Intimacy |
6.35; 5.77 | — |
| SECONDARY Change in Patients' Self-Reported Relationship Quality |
1.20; 2.49 | — |
| SECONDARY Change in Partners' Self-Reported Relationship Quality |
1.65; 1.27 | — |
| SECONDARY Change in Patients' Self-Reported Anxiety |
-0.70; 0.07 | — |
| SECONDARY Change in Partners' Self-Reported Anxiety |
-0.98; 0.27 | — |
| SECONDARY Change in Patients' Self-Reported Depressive Symptoms |
-0.99; -0.74 | — |
| SECONDARY Change in Partners' Self-Reported Depressive Symptoms |
-0.61; -0.16 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is female
- Patient age 18 years or older
- Patient has a medically confirmed diagnosis of non-recurrent breast cancer (Stages T1-T4, N0-N1, M0)
- Patient completed active treatment (e.g., chemotherapy, radiation therapy, surgery, immunotherapy) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Patient is currently in a partnered relationship that could involve sexual activity
- Partner or spouse is 18 years or older
- Patient lives with a romantic partner for at least 6 months
- Patient has a score of at least 3 on Patient Care Monitor Sexual Concerns screening item
Exclusion Criteria
- Patient or partner is not able to speak and read English, as stated in medical record, as observed by study team member or in self-report
- Patient or partner ECOG Performance score > 2 OR medically unable to participate as judged by physician/in medical record or by self-report
- Patient or partner has a hearing impairment
- Patient and partner do not have reliable telephone access
- Patient has overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, physician or referring source, or self-report
- Patient past or current history of any cancer other than non-melanoma skin cancer, including prior breast cancer
- Patient is currently participating in couple/marital therapy
- Patient is currently pregnant
Data sourced from ClinicalTrials.gov (NCT03930797). 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.