Couples' QOL in Metastatic Breast Cancer (C-QOL)

Quality of Life for Couples Facing Metastatic Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Breast Cancer
• Intervention / Treatment: Behavioral: Adapted Intimacy Enhancement; Behavioral: Intimacy Facts and Resources

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer B. Reese, PhD; Phone Number: 215-214-3223; Email: jennifer.reese@fccc.edu
• Study Contact Backup: Name: Kristen A. Sorice; Phone Number: 215-214-1433; Email: kristen.sorice@fccc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Recruiting
      • Fox Chase Cancer Center
      • Contact: Kristen Sorice; Phone Number: 215-214-1433; Email: kristen.sorice@fccc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapted Intimacy Enhancement; Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer	Behavioral: Adapted Intimacy Enhancement; Participants attend four virtual sessions (60-75 minutes) with a couples' coach consisting of education and skills training to enhance physical and emotional intimacy.; Behavioral: Intimacy Facts and Resources; Self-guided booklet of readings/resources about intimacy and metastatic breast cancer
Active Comparator: Intimacy Facts & Resources; Participants read a booklet about intimacy and metastatic breast cancer.	Behavioral: Intimacy Facts and Resources; Self-guided booklet of readings/resources about intimacy and metastatic breast cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Self-Reported Intimacy-Related Communication	Sexual communication is assessed through a brief 6-item version of the Dyadic Sexual Communication Scale (DSCS). Total scale scores range from 1 to 36. Higher scores indicate higher quality of intimacy-related communication. Change in patient mean score over time will be reported. Positive mean change scores indicate increase in quality of sexual communication.	Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Relationship Intimacy	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.	Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Anxiety	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.	Baseline, 9 weeks, 6 months
Change in Patient Self-Reported Depressive Symptoms	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.	Baseline, 9 weeks, 6 months
Change in Self-Reported Partner Sexual Function	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. 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 Partner Sexual Distress	Partner sexual distress will be measured using the 25-item Index of Sexual Satisfaction (ISS). Total scale scores range from 0 to 100. Higher scores indicate higher levels of sexual distress. Change in partner 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 Partner Self-Reported Self-Efficacy for Coping with Sexual Concerns	Partner self-efficacy for coping with sexual concerns will be measured using 3 items asking how certain the partner is that he/she can deal with issues related to physical intimacy. Scores range from 0 to 10, with higher scores indicating higher self-efficacy. Change in partner 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
Change in Partner Self-Reported Intimacy-Related Communication	Sexual communication is assessed through a brief 6-item version of the Dyadic Sexual Communication Scale (DSCS). Total scale scores range from 1 to 36. Higher scores indicate higher quality of intimacy-related communication. Change in partner mean score over time will be reported. Positive mean change scores indicate increase in quality of sexual communication.	Baseline to 9 weeks
Change in Partner Self-Reported Relationship Intimacy	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 partner mean relationship intimacy score over time will be reported. Positive mean change scores indicate increase in relationship intimacy.	Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Anxiety	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.	Baseline, 9 weeks, 6 months
Change in Partner Self-Reported Depressive Symptoms	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.	Baseline, 9 weeks, 6 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: American Cancer Society, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 20-1039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No