Clinical trial NCT06879522: Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors
Official title: Feasibility and Early Efficacy of the Maximizing Energy Intervention for Decreasing Fatigue Impact in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Survivor
Cancer Related Fatigue
Keywords: self-management
problem solving therapy
actigraphy
occupational therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Retention in the study
timeFrame: Baseline to Week 11 (4 weeks post-intervention)
measure: Participant Adherence to treatment: Receipt
timeFrame: Week 7 (post-6-week intervention)
measure: Participant Adherence to treatment: Receipt
timeFrame: Week 7 (post-6-week intervention)
measure: Participant Adherence to treatment: Enactment
timeFrame: Week 7(post-6-week intervention)
measure: Participant Satisfaction with Intervention
timeFrame: Week 7(post-6-week intervention)
measure: Intervention Fidelity
timeFrame: Week 7(post-6-week intervention)
measure: Changes in fatigue
timeFrame: Baseline to Week 11 (4 weeks post-intervention)
Secondary outcomes:
measure: Changes in resilience
timeFrame: Baseline to Week 11 (4 weeks post-intervention)
measure: Changes in impact of fatigue in daily life
timeFrame: Baseline to Week 11 (4 weeks post-intervention)
measure: Changes in fatigue severity
timeFrame: Baseline to Week 11 (4 weeks post-intervention)
measure: Change in physical activity: Step Count
timeFrame: Baseline to Week 11 (4 weeks post-intervention)
measure: Change in Physical Activity: Energy Expenditure
timeFrame: Baseline to Week 11 (4 weeks post-intervention)
measure: Change in physical activity: Intensity of Activity
timeFrame: Baseline to Week 11 (4 weeks post-intervention)
Other outcomes:
measure: Commonly used strategies to manage fatigue
timeFrame: Baseline to 4-weeks after intervention completion
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Ketki Raina, PhD, OTR/L, FAOTA
role: PRINCIPAL_INVESTIGATOR
References: