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Trial Title:
Couples' QOL in Metastatic Breast Cancer
NCT ID:
NCT05636943
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Adapted Intimacy Enhancement
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.
Arm group label:
Adapted Intimacy Enhancement
Intervention type:
Behavioral
Intervention name:
Intimacy Facts and Resources
Description:
Self-guided booklet of readings/resources about intimacy and metastatic breast cancer
Arm group label:
Adapted Intimacy Enhancement
Arm group label:
Intimacy Facts & Resources
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fox Chase Cancer Center
Address:
City:
Philadelphia
Zip:
19111
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristen Sorice
Phone:
215-214-1433
Email:
kristen.sorice@fccc.edu
Start date:
January 1, 2021
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Fox Chase Cancer Center
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Source:
Fox Chase Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05636943
