Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors

Not Applicable

Recruiting

• Conditions: Breast Cancer Survivor; Cancer Related Fatigue

• Registration Number: NCT06879522
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-10
• Study Start: 2025-03-15
• Study First Posted: 2025-03-17
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-03-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention in the study	Baseline to Week 11 (4 weeks post-intervention)	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
Participant Adherence to treatment: Receipt	Week 7 (post-6-week intervention)	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.
Participant Adherence to treatment: Enactment	Week 7(post-6-week intervention)	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.
Participant Satisfaction with Intervention	Week 7(post-6-week 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.
Intervention Fidelity	Week 7(post-6-week intervention)	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.
Changes in fatigue	Baseline to Week 11 (4 weeks post-intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Changes in impact of fatigue in daily life	Baseline to Week 11 (4 weeks post-intervention)	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.
Changes in fatigue severity	Baseline to Week 11 (4 weeks post-intervention)	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.
Changes in resilience	Baseline to Week 11 (4 weeks post-intervention)	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.
Change in physical activity: Step Count	Baseline to Week 11 (4 weeks post-intervention)	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.
Change in Physical Activity: Energy Expenditure	Baseline to Week 11 (4 weeks post-intervention)	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.
Change in physical activity: Intensity of Activity	Baseline to Week 11 (4 weeks post-intervention)	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States