Breast Cancer SurvivorBCS_MAXNCT06879522
Maximizing Energy and Reducing Fatigue in Breast Cancer Survivors
A study testing Maximizing Energy Intervention and Health Education in people with Breast Cancer Survivor and Cancer Related Fatigue, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Survivor, Cancer Related Fatigue
- What is being tested?
- Maximizing Energy Intervention and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2025to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- major depressive disorder, mania, hypomania, psychosis, or substance abuse in the past 3 months and
- disability due to diagnoses other than breast cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15219
About this study
Official title: 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:
- 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.
- 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.
Read more
Participant will:
- Take tests to see if they qualify and to measure their fatigue.
- Be randomized to receive Maximizing Energy or Health Education Interventions for 6 sessions over the internet
- 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
- Being tested
- Maximizing Energy Intervention, Health Education
- Keywords
- self-management, problem solving therapy, actigraphy, occupational therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximizing Energy InterventionBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Maximizing Energy | Experimental | Maximizing Energy Receives: Behavioral: Maximizing Energy Intervention |
| Health Education | Active comparator | Health Education Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 11 (4 weeks post-intervention)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 11 (4 weeks post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start14 May 2025
- Primary completion23 Jan 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ketki Raina, University of Pittsburgh
- Investigators
- Ketki Raina, PhD, OTR/L, FAOTA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879522
- Sponsor's protocol ID
- STUDY24050068
- Acronym
- BCS_MAX
- Status last verified
- Apr 2026
- First submitted
- 24 Feb 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Early Efficacy of the Maximizing Energy Intervention for Decreasing Fatigue Impact in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06879522
- Acronym / sponsor ID
- BCS_MAX / STUDY24050068
- Conditions
- Breast Cancer Survivor, Cancer Related Fatigue
- Keywords
- self-management, problem solving therapy, actigraphy, occupational therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 14 May 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- Take tests to see if they qualify and to measure their fatigue.
- Be randomized to receive Maximizing Energy or Health Education Interventions for 6 sessions over the internet
- After the sessions and again one month later, repeat some tests to see if their fatigue has improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximizing Energy | Experimental | Behavioral: Maximizing Energy InterventionMaximizing Energy |
| Health Education | Active comparator | Behavioral: Health EducationHealth Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- major depressive disorder, mania, hypomania, psychosis, or substance abuse in the past 3 months and
- disability due to diagnoses other than breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximizing Energy InterventionA 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. | Behavioural | Maximizing Energy |
| Health EducationTo 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. | Behavioural | Health Education |
Primary outcome
Retention in the study
Time frame: 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
Time frame: Week 7 (post-6-week intervention)
The investigators will collect data on the number of intervention sessions attended by participants
Participant Adherence to treatment: Receipt
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
6 secondary outcomes
Changes in resilience
Time frame: Baseline to Week 11 (4 weeks post-intervention)
Changes in impact of fatigue in daily life
Time frame: Baseline to Week 11 (4 weeks post-intervention)
Changes in fatigue severity
Time frame: Baseline to Week 11 (4 weeks post-intervention)
Change in physical activity: Step Count
Time frame: Baseline to Week 11 (4 weeks post-intervention)
Change in Physical Activity: Energy Expenditure
Time frame: Baseline to Week 11 (4 weeks post-intervention)
Change in physical activity: Intensity of Activity
Time frame: Baseline to Week 11 (4 weeks post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Survivor
Not yet recruiting
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
Breast Cancer, Fatigue in Cancer Survivors
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Active, not recruitingPhase 2
A Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors
Breast Cancer, Hyposexual Desire Disorder
Active, not recruitingObservational study
A Study of Attention and Memory Processes in Breast Cancer Survivors
Breast Cancer Survivors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketki Raina, PhD, OTR/L, FAOTA principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximizing Energy Intervention and Health Education in people with Breast Cancer Survivor and Cancer Related Fatigue, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in the study (time frame: Baseline to Week 11 (4 weeks post-intervention)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.