Clinical trial NCT05636943: Couples' QOL in Metastatic Breast Cancer
Official title: Quality of Life for Couples Facing Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2022-12-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in Self-Reported Patient Sexual Function
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Self-Reported Patient Sexual Distress
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Patient Self-Reported Self-Efficacy for Coping with Sexual Concerns
timeFrame: Baseline, 9 weeks, 6 months
Secondary outcomes:
measure: Change in Patient Self-Reported Intimacy-Related Communication
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Patient Self-Reported Relationship Intimacy
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Patient Self-Reported Anxiety
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Patient Self-Reported Depressive Symptoms
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Self-Reported Partner Sexual Function
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Self-Reported Partner Sexual Distress
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Partner Self-Reported Self-Efficacy for Coping with Sexual Concerns
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Partner Self-Reported Intimacy-Related Communication
timeFrame: Baseline to 9 weeks
measure: Change in Partner Self-Reported Relationship Intimacy
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Partner Self-Reported Anxiety
timeFrame: Baseline, 9 weeks, 6 months
measure: Change in Partner Self-Reported Depressive Symptoms
timeFrame: Baseline, 9 weeks, 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: