Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors

NCT ID: NCT06879522

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-14
• Study Completion Date: 2026-03-15

Brief Summary

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.

Conditions

Breast Cancer Survivor; Cancer Related Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Maximizing Energy

Maximizing Energy

Group Type: EXPERIMENTAL

Maximizing Energy Intervention

Intervention Type: BEHAVIORAL

A licensed occupational therapist will deliver the intervention. The Maximizing Energy program combines problem-solving therapy (PST) and energy conservation education. Participants will participate in 6 virtual once/week sessions for 30 minutes. The introductory session, they will track their fatigue and identify three key fatigue-related problems. In session 2, they will prioritize one problem and practice problem-solving steps. They then implement an action plan and review progress in the next session. If the solution is ineffective, the therapist helps modify it or create a new one. If successful, the participant moves to the next problem. A MAX workbook supports learning, covering intervention details, fatigue education, energy conservation strategies, and problem-solving worksheets. The goal is to help participants apply these strategies to improve daily life and return to work.

Health Education

Health Education

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: BEHAVIORAL

To control for the effects of interactions with an interventionist, participants in the attention control group will receive the Health Education intervention. The interventionists will review a workbook covering fatigue, energy conservation, healthy eating, exercise, and relaxation. Like the MAX intervention, Health Education will be delivered virtually in weekly 30-minute one-on-one sessions for six weeks. The interventionist provides education on breast cancer-related fatigue, diet, safe physical activities, and energy conservation strategies tailored to individual needs. A workbook will support learning.

Interventions

Maximizing Energy Intervention

A licensed occupational therapist will deliver the intervention. The Maximizing Energy program combines problem-solving therapy (PST) and energy conservation education. Participants will participate in 6 virtual once/week sessions for 30 minutes. The introductory session, they will track their fatigue and identify three key fatigue-related problems. In session 2, they will prioritize one problem and practice problem-solving steps. They then implement an action plan and review progress in the next session. If the solution is ineffective, the therapist helps modify it or create a new one. If successful, the participant moves to the next problem. A MAX workbook supports learning, covering intervention details, fatigue education, energy conservation strategies, and problem-solving worksheets. The goal is to help participants apply these strategies to improve daily life and return to work.

Intervention Type: BEHAVIORAL

Health Education

To control for the effects of interactions with an interventionist, participants in the attention control group will receive the Health Education intervention. The interventionists will review a workbook covering fatigue, energy conservation, healthy eating, exercise, and relaxation. Like the MAX intervention, Health Education will be delivered virtually in weekly 30-minute one-on-one sessions for six weeks. The interventionist provides education on breast cancer-related fatigue, diet, safe physical activities, and energy conservation strategies tailored to individual needs. A workbook will support learning.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Ketki Raina

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ketki Raina, PhD, OTR/L, FAOTA

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Tracey Y Murray

Role: CONTACT

tym2@pitt.edu

412-624-3961

Facility Contacts

Tracey Y Murray

Role: primary

tym2@pitt.edu

412-624-3961

Other Identifiers

STUDY24050068

Identifier Type: -

Identifier Source: org_study_id