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

Feasibility and Early Efficacy of the Maximizing Energy Intervention for Decreasing Fatigue Impact in Breast Cancer Survivors

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Survivor; Cancer Related Fatigue
• Intervention / Treatment: Behavioral: Maximizing Energy Intervention; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Health Education	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.
Experimental: Maximizing Energy	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in the study	The proportion of participants who remain in the study until its completion relative to those initially enrolled. The retention rate will be calculated separately for the Maximizing Energy and Control Groups using the following formula: (number of participants who completed the study/number of participants initially enrolled)X 100	Baseline to Week 11 (4 weeks post-intervention)
Participant Adherence to treatment: Receipt	The investigators will collect data on the number of intervention sessions attended by participants	Week 7 (post-6-week intervention)
Participant Adherence to treatment: Receipt	Interventionists will rate participant's active engagement in the interventions on the Pittsburgh Participant Rating Scale. Each session will be scored 1 (no engagement, refusal) to 6 (excellent engagement) by the interventionist conducting the sessions.	Week 7 (post-6-week intervention)
Participant Adherence to treatment: Enactment	The investigators will collect interventionist rating of whether participant completed action plan from previous session (3-point scale; 0 = not completed, 2 = plan completed) for the MAX Intervention group only.	Week 7(post-6-week intervention)
Participant Satisfaction with Intervention	Client satisfaction is measured using the Client Satisfaction Questionnaire. The Clients Satisfaction Questionnaire is an 8-item assessment of satisfaction with the intervention program, rated on a 4-point scale that ranges from 1 to 4 in each item. Higher scores indicate greater satisfaction with the intervention.	Week 7(post-6-week intervention)
Intervention Fidelity	All intervention sessions will be video recorded and a random 20 percent will be rated by independent evaluators trained by the principal investigator. Intervention fidelity for both groups will be assessed using the PST Provider Checklist. The a priori criterion for adequate fidelity was that equal or greater than 80 percent of intervention sessions are rated with equal or greater than 80 percent of adequate fidelity for the MAX Intervention group while less than 20 percent of intervention sessions are rated with equal or lesser than 20 percent of adequate fidelity for the Health Education group.	Week 7(post-6-week intervention)
Changes in fatigue	The PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) is a 13-item questionnaire designed to assess fatigue levels and their impact on daily activities and quality of life. Each item is scored on a 5-point Likert scale (1 = not at all to 5 = very much), with a total score ranging from 13 to 65. Higher scores indicate greater fatigue, while lower scores suggest less fatigue and better energy levels.	Baseline to Week 11 (4 weeks post-intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in resilience	The Connor-Davidson Resilience Scale (CD-RISC) is a tool designed to measure an individual's resilience, or ability to adapt to stress and adversity. It consists of 25 items, each rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time), with total scores ranging from 0 to 100. Higher scores indicate greater resilience, reflecting stronger coping skills and adaptability in challenging situations.	Baseline to Week 11 (4 weeks post-intervention)
Changes in impact of fatigue in daily life	The Modified Fatigue Impact Scale (MFIS) is a 21-item questionnaire that assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale (0 = never to 4 = almost always), with a total score ranging from 0 to 84. Higher scores indicate a greater negative impact of fatigue on daily life, while lower scores suggest minimal interference with functioning.	Baseline to Week 11 (4 weeks post-intervention)
Changes in fatigue severity	The Fatigue Severity Scale (FSS) is a 9-item questionnaire designed to assess the impact of fatigue on daily life and functioning. Each item is rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with total scores ranging from 9 to 63. Higher scores indicate greater fatigue severity and its interference with daily activities, while lower scores suggest minimal fatigue impact.	Baseline to Week 11 (4 weeks post-intervention)
Change in physical activity: Step Count	The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including step count. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a mean number of steps taken daily.	Baseline to Week 11 (4 weeks post-intervention)
Change in Physical Activity: Energy Expenditure	The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including energy expenditure. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a mean energy expenditure daily.	Baseline to Week 11 (4 weeks post-intervention)
Change in physical activity: Intensity of Activity	The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including percentage of time spent in sedentary, light, moderate, and vigorous physical activity. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a percentage of time spent in different intensity activity daily.	Baseline to Week 11 (4 weeks post-intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Commonly used strategies to manage fatigue	The Energy Conservation Strategies Survey assesses which energy conservation strategies they have used in the past 6 weeks and how effective they perceive these strategies to be in managing their fatigue. The survey lists 14 strategies. Strategy effectiveness in managing fatigue is rated on a 10-point scale with 1 indicating not effective and 10 indicating very effective.	Baseline to 4-weeks after intervention completion

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Ketki Raina, PhD, OTR/L, FAOTA, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2025
• Primary Completion (Actual): January 23, 2026
• Study Completion (Actual): February 2, 2026

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 10, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: self-management; occupational therapy; actigraphy; problem solving therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Fatigue
• Other Study ID Numbers: STUDY24050068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No