Coping Together After Breast Cancer

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Behavioral: Intimacy Enhancement
Behavioral: Living Healthy Together

Registration Number: NCT03930797

Lead Sponsor: Fox Chase Cancer Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 240

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intimacy Enhancement	Intimacy Enhancement	Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.
Living Healthy Together	Living Healthy Together	Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.

Primary Outcome Measures

Name	Time	Method
Change in Self-Reported Patient Sexual Function	Baseline up to 6 weeks	Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.

Secondary Outcome Measures

Name	Time	Method
Change in Self-Reported Patient Sexual Distress	Baseline up to 6 weeks	Patient sexual distress will be measured using the 13-item Female Sexual Distress Scale-Revised (FSDS-R). Total scale scores range from 0 to 52. Higher scores indicate higher levels of sexual distress. Change in patient mean sexual distress score over time will be reported. Negative mean change scores indicate decrease in sexual distress.
Change in Patients' Self-Reported Relationship Intimacy	Baseline up to 6 weeks	Patient self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.
Change in Partners' Self-Reported Anxiety	Baseline up to 6 weeks	Partners' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety.
Change in Partners' Self-Reported Depressive Symptoms	Baseline up to 6 weeks	Partners' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression.
Change in Partners' Self-Reported Relationship Intimacy	Baseline up to 6 weeks	Partner self-reported relationship intimacy will be measured using the 17-item Miller Social Intimacy Scale (MSIS). This scale assesses emotional intimacy, closeness and trust toward an individual's partner. Scores range from 17 to 170, with higher scores indicating higher levels of intimacy. Change in patient mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.
Change in Partners' Self-Reported Relationship Quality	Baseline up to 6 weeks	Partner self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality.
Change in Self-Reported Partner Sexual Function	Baseline up to 6 weeks	Partners' (male) self-reported sexual function will be measured using the 15-item International Index of Erectile Function (IIEF). Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning. Change in mean male partner IIEF score over time will be reported. Positive mean change scores indicate increase in sexual functioning.
Change in Patients' Self-Reported Relationship Quality	Baseline up to 6 weeks	Patient self-reported relationship quality will be measured using the 7-item Dyadic Adjustment Scale (DAS-7). Total scale scores range from 0 to 36. Higher scores indicate higher relationship quality. Change in mean relationship quality score over time will be reported. Positive mean change scores indicate increase in relationship quality.
Change in Patients' Self-Reported Anxiety	Baseline up to 6 weeks	Patients' self-reported anxiety will be measured using the 7-item Generalized Anxiety Disorder scale (GAD-7). Total scale scores range from 0 to 21. Higher scores indicate higher levels of anxiety. Change in mean anxiety score over time will be reported. Negative mean change scores indicate decrease in anxiety.
Change in Patients' Self-Reported Depressive Symptoms	Baseline up to 6 weeks	Patients' self-reported depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Total scale scores range from 0 to 27. Higher scores indicate higher levels of depression. Change in mean depression score over time will be reported. Negative mean change scores indicate decrease in depression.