Clinical trial NCT03930797: Coping Together After Breast Cancer
Official title: Addressing Sexual Concerns in Breast Cancer Survivors: Randomized Controlled Trial of a Novel Couple-Based Intervention
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: 2019-04-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Over half of breast cancer survivors experience sexual concerns resulting from physical changes due to breast surgery, chemotherapy, and hormonal therapies; emotional changes; and relationship difficulties. In contrast with many aspects of quality of life (QOL) that tend to improve over time for breast cancer survivors, sexual concerns often persist for years. As a result, many breast cancer survivors and their partners may wish to resume a satisfying intimate relationship after treatment ends but encounter difficulties in doing so. Sexual concerns often go unaddressed, can lead to clinically significant psychological distress, and have a negative impact on survivors' relationships and quality of life. Thus, addressing sexual concerns and improving sexual function is of critical importance to the long-term adjustment of these survivors. Given the central role of the intimate relationship in breast cancer survivors' sexual experiences, a couple-based intervention that systematically involves the partner may be a highly effective approach for addressing these concerns and improving function. Yet randomized controlled trials evaluating the efficacy of a couple-based intervention targeting sexual function for breast cancer survivors are lacking. In this study, the investigators plan to evaluate a four-session telephone couple-based intervention that provides education and training in cognitive and behavioral skills to help couples cope with sexual concerns and enhance their intimate relationship, called Intimacy Enhancement (IE).

The specific aims of this study are (1) to evaluate whether the IE intervention will lead to a significantly greater increase in patient sexual function from pre-treatment to post-treatment and 3- and 6-month follow-ups compared to the LHT condition; (2) to evaluate whether the IE intervention will lead to significantly greater improvements in partner sexual function, patient sexual distress, patient/partner relationship intimacy/quality, and psychological distress from pre-treatment to post-treatment and at 3- and 6-month follow-ups, compared to the LHT condition; (3) to evaluate whether increases from pre- to post-treatment in patient sexual communication and self-efficacy for coping with sexual concerns mediate the beneficial effects of the IE intervention on patient sexual function at 3- and 6-month follow-ups.

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

Primary outcomes:
measure: Change in Self-Reported Patient Sexual Function
timeFrame: Baseline up to 6 weeks
Secondary outcomes:
measure: Change in Self-Reported Partner Sexual Function
timeFrame: Baseline up to 6 weeks
measure: Change in Self-Reported Patient Sexual Distress
timeFrame: Baseline up to 6 weeks
measure: Change in Patients' Self-Reported Relationship Intimacy
timeFrame: Baseline up to 6 weeks
measure: Change in Partners' Self-Reported Relationship Intimacy
timeFrame: Baseline up to 6 weeks
measure: Change in Patients' Self-Reported Relationship Quality
timeFrame: Baseline up to 6 weeks
measure: Change in Partners' Self-Reported Relationship Quality
timeFrame: Baseline up to 6 weeks
measure: Change in Patients' Self-Reported Anxiety
timeFrame: Baseline up to 6 weeks
measure: Change in Partners' Self-Reported Anxiety
timeFrame: Baseline up to 6 weeks
measure: Change in Patients' Self-Reported Depressive Symptoms
timeFrame: Baseline up to 6 weeks
measure: Change in Partners' Self-Reported Depressive Symptoms
timeFrame: Baseline up to 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References:
citation: Reese JB, Zimmaro LA, Lepore SJ, Sorice KA, Handorf E, Daly MB, Schover LR, Kashy D, Westbrook K, Porter LS. Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial. Trials. 2020 Feb 12;21(1):173. doi: 10.1186/s13063-019-3975-2.