Couples' QOL in Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Quality of Life for Couples Facing Metastatic Breast Cancer

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Behavioral: Adapted Intimacy Enhancement
* Behavioral: Intimacy Facts and Resources


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |