Coping Together After Breast Cancer

NCT03930797 | Completed Results

• 2 other identifiers: 18-10251R01CA222124-01A1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in Self-Reported Patient Sexual Function

  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.

  Baseline up to 6 weeks

Secondary Outcomes (10)

• Change in Self-Reported Partner Sexual Function

  Baseline up to 6 weeks

• Change in Self-Reported Patient Sexual Distress

  Baseline up to 6 weeks

• Change in Patients' Self-Reported Relationship Intimacy

  Baseline up to 6 weeks

• Change in Partners' Self-Reported Relationship Intimacy

  Baseline up to 6 weeks

• Change in Patients' Self-Reported Relationship Quality

  Baseline up to 6 weeks

Study Arms (2)

Intimacy Enhancement

EXPERIMENTAL

Participants attend four sessions (60-75 minutes) consisting of education and skills training to enhance physical and emotional intimacy.

Behavioral: Intimacy Enhancement

Living Healthy Together

ACTIVE COMPARATOR

Participants attend four sessions (60-75 minutes) consisting of information and support across a range of breast cancer-related topics.

Behavioral: Living Healthy Together

Interventions

Intimacy Enhancement BEHAVIORAL

The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.

Intimacy Enhancement

Living Healthy Together BEHAVIORAL

The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.

Living Healthy Together

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (1)

• 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.

  PMID: 32051002 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Jennifer Reese, Associate Professor
• Organization: Fox Chase Cancer Center

Jennifer.Reese@fccc.edu

215-214-3223

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: May 24, 2019
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)