Telephone Support for Metastatic Breast Cancer Patients

Completed · Not applicable

Conditions studied: Metastatic Breast Cancer

In brief

This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in metastatic breast cancer (MBC) cancer patients. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, work), and engaging in activities consistent with these values. A total of 250 patients will be randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Patients in both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. A demonstration of ACT's efficacy will lead to dissemination of the intervention and ultimately fulfill an unmet need in the comprehensive care of MBC patients.

Key facts

Study ID

NCT03998618

Run by

Indiana University

People needed

250

Starts

2019-06-20

Expected to finish

2023-09-13

Last updated by the study team

2024-10-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patient is at least 3 weeks post-diagnosis of stage IV breast cancer and is receiving care at the Indiana University (IU) Simon Cancer Center, Eskenazi Health, IU Health North, IU Health Bloomington, IU Health Ball Memorial, IU Health Portland, IU Health Morgan, IU Health New Castle, IU Health Central-Fishers, another IU Health hospital or clinic, Community Health Network, or the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.
• Patient is at least 18 years of age.
• Patient has adequate English fluency for completion of data collection.
• Patient has moderate to severe fatigue interference with functioning

You may not qualify if…

• Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation.
• Patient reports being able to do little activity on a functional status measure.
• Patient is receiving hospice care at screening.
• Patient does not have working phone service.
• Patient has hearing impairment that precludes participation.
• Male sex

Where it is running

• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States
• Community Health Network — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.