Couples' QOL in Metastatic Breast Cancer

NCT05636943 | Active Not Recruiting

• 1 other identifier: 20-1039
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study are to adapt and evaluate a sexual quality of life intervention in women with metastatic breast cancer and their partners.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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, 9 weeks, 6 months

• Change in Self-Reported Patient Sexual Distress

  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.

  Baseline, 9 weeks, 6 months

• Change in Patient Self-Reported Self-Efficacy for Coping with Sexual Concerns

  Patient self-efficacy for coping with sexual concerns will be measured using 3 items asking how certain the patient is that she can deal with issues related to physical intimacy. Scores range from 0 to 10, with higher scores indicating higher self-efficacy. Change in patient mean self-efficacy score over time will be reported, with a positive change score reflecting an increase in self-efficacy.

  Baseline, 9 weeks, 6 months

Secondary Outcomes (11)

• Change in Patient Self-Reported Intimacy-Related Communication

  Baseline, 9 weeks, 6 months

• Change in Patient Self-Reported Relationship Intimacy

  Baseline, 9 weeks, 6 months

• Change in Patient Self-Reported Anxiety

  Baseline, 9 weeks, 6 months

• Change in Patient Self-Reported Depressive Symptoms

  Baseline, 9 weeks, 6 months

• Change in Self-Reported Partner Sexual Function

  Baseline, 9 weeks, 6 months

Study Arms (2)

Adapted Intimacy Enhancement

EXPERIMENTAL

Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer

Behavioral: Adapted Intimacy Enhancement; Behavioral: Intimacy Facts and Resources

Intimacy Facts & Resources

ACTIVE COMPARATOR

Participants read a booklet about intimacy and metastatic breast cancer.

Behavioral: Intimacy Facts and Resources

Interventions

Adapted Intimacy Enhancement BEHAVIORAL

Participants attend four virtual sessions (60-75 minutes) with a couples' coach consisting of education and skills training to enhance physical and emotional intimacy.

Adapted Intimacy Enhancement

Intimacy Facts and Resources BEHAVIORAL

Self-guided booklet of readings/resources about intimacy and metastatic breast cancer

Adapted Intimacy Enhancement; Intimacy Facts & Resources

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 is at least 18 years old
• Patient has a diagnosis of metastatic (stage IV) breast cancer
• Patient has a partner or spouse who is at least 18 years old
• Patient lives with a romantic partner (same or opposite sex) for at least 6 months
• Patient scores 3 or above on Patient Care Monitor sexual concerns item (range: 0-10)

You may not qualify if:

• Patient or partner is not able to speak and read English
• Patient or partner has a hearing impairment
• Patient or partner medically unable to participate as judged by physician/in medical record or by self-report
• 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 or breast cancer
• Patient is currently participating in couple/marital therapy
• Patient is currently pregnant

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• American Cancer Society, Inc.: collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Health Resources

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 5, 2022
• Study Start: January 1, 2021
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)