Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer

Temple University Health System (TUHS)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Behavioral, Psychological or Informational Intervention; Behavioral: Intimacy Enhancing Intervention; Behavioral: Partner-Assisted Coping Skills Training; Behavioral: Living Healthy Together

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02721147

1R21CA191354-01 (U.S. NIH Grant/Contract)

15-8007

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Intimacy Enhancing Intervention

Experimental group

Description:

Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.

Treatment:

Behavioral: Partner-Assisted Coping Skills Training

Behavioral: Intimacy Enhancing Intervention

Living Healthy Together

Active Comparator group

Description:

Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.

Treatment:

Behavioral: Living Healthy Together

Behavioral: Behavioral, Psychological or Informational Intervention