Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors (BCS_MAX)

University of Pittsburgh

Status: Enrolling

Conditions: Cancer Related Fatigue; Breast Cancer Survivor

Treatments: Behavioral: Health Education; Behavioral: Maximizing Energy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06879522

STUDY24050068

Details and patient eligibility

About

This study is testing a program called Maximizing Energy to see if it can help women who have finished breast cancer treatment manage their fatigue. The study has two main goals:

1. Check if the program can be successfully delivered - Researchers will see if women are willing to join and stay in the study, if they follow the program, and if they find it helpful.
2. See if the program works - Researchers will compare Maximizing Energy to a general health education program to see which one helps reduce cancer-related fatigue better.

Participant will:

1. Take tests to see if they qualify and to measure their fatigue.
2. Be randomized to receive Maximizing Energy or Health Education Interventions for 6 sessions over the internet
3. After the sessions and again one month later, repeat some tests to see if their fatigue has improved.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult (18 years and older) pre and post-menopausal female at birth diagnosed with Stages I-IIIa breast cancer,
• completed primary treatment for breast cancer (surgery, chemotherapy, radiation) at least 6 months prior to ensure that fatigue is stable and chronic, - moderate to severe fatigue based on score ≥ 4 on the 7-point Fatigue Severity Scale,
• able to speak and understand English
• has a mobile device that runs on the Apple or Android platform

Exclusion criteria

• major depressive disorder, mania, hypomania, psychosis, or substance abuse in the past 3 months and
• disability due to diagnoses other than breast cancer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Maximizing Energy

Experimental group

Description:

Maximizing Energy

Treatment:

Behavioral: Maximizing Energy Intervention

Health Education

Active Comparator group

Description:

Health Education

Treatment:

Behavioral: Health Education