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

NCT ID: NCT02721147

Last Updated: 2018-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-27
• Study Completion Date: 2017-09-29

Brief 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intimacy Enhancing Intervention

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.

Group Type: EXPERIMENTAL

Intimacy Enhancing Intervention

Intervention Type: BEHAVIORAL

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.

Partner-Assisted Coping Skills Training

Intervention Type: BEHAVIORAL

Receive couple-based intimacy enhancement intervention

Living Healthy Together

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.

Group Type: ACTIVE_COMPARATOR

Living Healthy Together

Intervention Type: BEHAVIORAL

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.

Behavioral, Psychological or Informational Intervention

Intervention Type: BEHAVIORAL

Receive educational information and support

Interventions

Intimacy Enhancing Intervention

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.

Intervention Type: BEHAVIORAL

Living Healthy Together

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.

Intervention Type: BEHAVIORAL

Partner-Assisted Coping Skills Training

Receive couple-based intimacy enhancement intervention

Intervention Type: BEHAVIORAL

Behavioral, Psychological or Informational Intervention

Receive educational information and support

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21CA191354-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15-8007

Identifier Type: -

Identifier Source: org_study_id