Back to resultsCouples' QOL in Metastatic Breast Cancer (C-QOL)
Primary Purpose
Metastatic Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adapted Intimacy Enhancement
Intimacy Facts and Resources
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Fox Chase Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adapted Intimacy Enhancement
Intimacy Facts & Resources
Arm Description
Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer
Participants read a booklet about intimacy and metastatic breast cancer.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05636943
First Posted
November 21, 2022
Last Updated
December 5, 2022
Sponsor
Fox Chase Cancer Center
Collaborators
American Cancer Society, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05636943
Brief Title
Couples' QOL in Metastatic Breast Cancer
Acronym
C-QOL
Official Title
Quality of Life for Couples Facing Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
American Cancer Society, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adapted Intimacy Enhancement
Arm Type
Experimental
Arm Description
Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer
Arm Title
Intimacy Facts & Resources
Arm Type
Active Comparator
Arm Description
Participants read a booklet about intimacy and metastatic breast cancer.
Intervention Type
Behavioral
Intervention Name(s)
Adapted Intimacy Enhancement
Intervention Description
Participants attend four virtual sessions (60-75 minutes) with a couples' coach consisting of education and skills training to enhance physical and emotional intimacy.
Intervention Type
Behavioral
Intervention Name(s)
Intimacy Facts and Resources
Intervention Description
Self-guided booklet of readings/resources about intimacy and metastatic breast cancer
Primary Outcome Measure Information:
Title
Change in Self-Reported Patient Sexual Function
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Self-Reported Patient Sexual Distress
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Patient Self-Reported Self-Efficacy for Coping with Sexual Concerns
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Secondary Outcome Measure Information:
Title
Change in Patient Self-Reported Intimacy-Related Communication
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Patient Self-Reported Relationship Intimacy
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Patient Self-Reported Anxiety
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Patient Self-Reported Depressive Symptoms
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Self-Reported Partner Sexual Function
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Self-Reported Partner Sexual Distress
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Partner Self-Reported Self-Efficacy for Coping with Sexual Concerns
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Partner Self-Reported Intimacy-Related Communication
Description
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.
Time Frame
Baseline to 9 weeks
Title
Change in Partner Self-Reported Relationship Intimacy
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Partner Self-Reported Anxiety
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
Title
Change in Partner Self-Reported Depressive Symptoms
Description
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.
Time Frame
Baseline, 9 weeks, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer B. Reese, PhD
Phone
215-214-3223
Email
jennifer.reese@fccc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen A. Sorice
Phone
215-214-1433
Email
kristen.sorice@fccc.edu
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Sorice
Phone
215-214-1433
Email
kristen.sorice@fccc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Couples' QOL in Metastatic Breast Cancer
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