Couples' QOL in Metastatic Breast Cancer (C-QOL)

Temple University Health System (TUHS)

Status: Active, not recruiting

Conditions: Metastatic Breast Cancer

Treatments: Behavioral: Adapted Intimacy Enhancement; Behavioral: Intimacy Facts and Resources

Study type: Interventional

Funder types: Other

Identifiers

NCT05636943

20-1039

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

110 participants in 2 patient groups

Adapted Intimacy Enhancement

Experimental group

Description:

Participants receive intimacy enhancement sessions and read a booklet about intimacy and metastatic breast cancer

Treatment:

Behavioral: Intimacy Facts and Resources

Behavioral: Adapted Intimacy Enhancement

Intimacy Facts & Resources

Active Comparator group

Description:

Participants read a booklet about intimacy and metastatic breast cancer.

Treatment:

Behavioral: Intimacy Facts and Resources