Couples' QOL in Metastatic Breast Cancer

NCT ID: NCT05636943

Last Updated: 2025-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2025-05-30

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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Adapted Intimacy Enhancement

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

Group Type EXPERIMENTAL

Adapted Intimacy Enhancement

Intervention Type BEHAVIORAL

Participants attend four virtual sessions (60-75 minutes) with a couples' coach consisting of education and skills training to enhance physical and emotional intimacy.

Intimacy Facts and Resources

Intervention Type BEHAVIORAL

Self-guided booklet of readings/resources about intimacy and metastatic breast cancer

Intimacy Facts & Resources

Participants read a booklet about intimacy and metastatic breast cancer.

Group Type ACTIVE_COMPARATOR

Intimacy Facts and Resources

Intervention Type BEHAVIORAL

Self-guided booklet of readings/resources about intimacy and metastatic breast cancer

Interventions

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Adapted Intimacy Enhancement

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

Intimacy Facts and Resources

Self-guided booklet of readings/resources about intimacy and metastatic breast cancer

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fox Chase Cancer Center

OTHER

Sponsor Role lead

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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20-1039

Identifier Type: -

Identifier Source: org_study_id

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