Couples' QOL in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

— C-QOL  

Official title:

Quality of Life for Couples Facing Metastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636943
• Other study ID #: 20-1039
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2024
• Source: Fox Chase Cancer Center
• Contact: Jennifer B. Reese, PhD
• Phone: 215-214-3223
• Email: jennifer.reese[@]fccc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.
• Intimacy Facts and Resources
Self-guided booklet of readings/resources about intimacy and metastatic breast cancer

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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