Maximizing Energy Program for Fatigue After Breast Cancer

(BCS_MAX Trial)

Overseen By Tracey Y Murray

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Major depression, Mania, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called Maximizing Energy to help women manage ongoing fatigue after completing breast cancer treatment. Researchers aim to determine if this program can be delivered effectively and if it reduces fatigue more effectively than general health education. Participants will be randomly assigned to either the Maximizing Energy program or a health education group for six online sessions. Women who completed primary treatment for Stages I-IIIa breast cancer at least six months ago and experience moderate to severe fatigue are suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance quality of life for many.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the Maximizing Energy program is safe for managing fatigue after breast cancer?

Research shows that the "Maximizing Energy" program, which teaches energy-saving techniques, reduces mental tiredness in breast cancer survivors. Participants reported feeling less mentally exhausted after using the program. No major side effects have been reported, indicating it is well-tolerated. The trial is in a phase called "Not Applicable," meaning the treatment is considered safe enough for this stage of testing. This phase primarily focuses on the program's effectiveness rather than its safety. Researchers will compare participants in the study to those receiving general health education to determine which approach better reduces fatigue. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Maximizing Energy" program because it offers a fresh approach to tackling fatigue after breast cancer. Unlike standard options, which often focus on medication or unspecific lifestyle advice, this program is designed to directly empower patients through personalized energy management techniques. The emphasis is on practical strategies and education to help patients regain energy and improve their quality of life. This innovative focus on self-management and patient education sets it apart from traditional treatments and has the potential to significantly enhance recovery and well-being for breast cancer survivors.

What evidence suggests that this trial's treatments could be effective for managing fatigue after breast cancer?

Research has shown that the Maximizing Energy program, which participants in this trial may receive, can help reduce tiredness in breast cancer survivors. Participants in earlier studies reported feeling less tired, with scores ranging from 2.9 to 3.5 on a scale from 0 to 10. They also experienced good sleep, with sleep efficiency between 82% and 92%, indicating they stayed asleep through the night. Additionally, energy-saving techniques significantly reduced mental tiredness, helping participants feel less mentally exhausted. These findings suggest that the program could effectively manage tiredness after breast cancer treatment. Another group in this trial will receive Health Education, serving as an active comparator. ^{1 2 3 4 6}

Who Is on the Research Team?

Ketki Raina, PhD, OTR/L, FAOTA

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for women who have completed breast cancer treatment and are experiencing fatigue. Participants will be assessed to ensure they qualify and must be willing to attend 6 online sessions. There's no information provided on specific exclusion criteria.

Inclusion Criteria

Has a mobile device that runs on the Apple or Android platform

I often feel very tired.

Able to speak and understand English

Exclusion Criteria

Major depressive disorder, mania, hypomania, psychosis, or substance abuse in the past 3 months

Disability due to diagnoses other than breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Treatment

Participants receive either the Maximizing Energy or Health Education Interventions for 6 sessions over the internet

6 weeks

6 sessions (virtual)

Follow-up

Participants are monitored for changes in fatigue and other outcomes after the intervention

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Health Education
• Maximizing Energy

Trial Overview The study tests the 'Maximizing Energy' program against a general health education program, focusing on managing post-treatment fatigue in breast cancer survivors. Success will be measured by participants' willingness to join, adherence, perceived helpfulness, and improvement in fatigue levels.

How Is the Trial Designed?

Group I: Maximizing Energy Experimental Treatment 1 Intervention

Maximizing Energy

Group II: Health Education Active Control 1 Intervention

Health Education

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

A study involving 21 women with breast cancer showed that adherence to an Individualized Sleep Promotion Plan (ISPP) was high (77%-88%), which included strategies like sleep hygiene and relaxation therapy, leading to generally positive sleep outcomes after chemotherapy.

Participants experienced low levels of fatigue (2.9-3.5 on a 0-10 scale) and maintained good sleep efficiency (82%-92%), although nighttime awakenings were higher than desired, indicating that behavioral techniques for sleep promotion can be beneficial post-chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence, sleep, and fatigue outcomes after adjuvant breast cancer chemotherapy: results of a feasibility intervention study. Berger, AM., VonEssen, S., Kuhn, BR., et al.[2015]

In a study involving 360 women with early breast cancer undergoing chemotherapy and radiotherapy, an Adapted Physical Activity Diet (APAD) program did not significantly reduce cancer-related fatigue compared to usual care, indicating limited efficacy in this context.

However, the APAD program was associated with a smaller proportion of patients experiencing confirmed depression at the end of follow-up, suggesting potential mental health benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Hospital Supervision of Exercise and Diet During Adjuvant Breast Cancer Therapy Is Not Enough to Relieve Fatigue: A Multicenter Randomized Controlled Trial. Jacot, W., Arnaud, A., Jarlier, M., et al.[2021]

A study involving 64 women with chronic fatigue after breast cancer treatment found that both a multimodal mind-body program (MMMT) and a simple walking intervention significantly reduced fatigue symptoms over 10 weeks, with no significant difference in effectiveness between the two groups.

Both interventions also improved quality of life and functional well-being, leading researchers to recommend the more cost-effective home-based walking program since it provided similar benefits without the additional costs associated with MMMT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a multimodal mind-body program enhance the treatment effects of physical activity in breast cancer survivors with chronic tumor-associated fatigue? A randomized controlled trial. Spahn, G., Choi, KE., Kennemann, C., et al.[2014]

Cancer-related fatigue (CRF) can persist for years in cancer survivors, and nutritional interventions may help alleviate this fatigue by addressing inflammation and improving body composition.

Dietary patterns like the Mediterranean diet, increased protein intake, and supplements such as ginseng and probiotics have shown potential in reducing fatigue and improving energy levels in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional Interventions for Treating Cancer-Related Fatigue: A Qualitative Review. Inglis, JE., Lin, PJ., Kerns, SL., et al.[2020]

In a study of 42 breast cancer survivors, higher fat intake was linked to increased fatigue, while higher fiber and carbohydrate intake were associated with reduced fatigue levels.

Participants consuming less than 25 grams of fiber per day reported significantly higher fatigue compared to those consuming more, suggesting that a diet rich in fiber and low in fat may help alleviate fatigue in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet components associated with perceived fatigue in breast cancer survivors. Guest, DD., Evans, EM., Rogers, LQ.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06879522

Maximizing Energy and Reducing Fatigue in Breast ... 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.

2. withpower.com withpower.com/trial/phase-breast-neoplasms-2-2025-5fe76

Maximizing Energy Program for Fatigue After Breast Cancer Participants experienced low levels of fatigue (2.9-3.5 on a 0-10 scale) and maintained good sleep efficiency (82%-92%), although nighttime awakenings were ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5454632/

Effects of Energy Conservation Strategies on Cancer ... The current results demonstrate that applying energy conservation strategies significantly decreased the cognitive fatigue in the breast cancer survivors. It ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06879522/maximizing-energy-and-reducing-fatigue-in-breast-cancer-survivors?page=4&state=PA&city=Pittsburgh

Maximizing Energy and Reducing Fatigue in Breast ... This study is testing a program called Maximizing Energy to see if it can help women who have finished breast cancer treatment manage their ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT06879522

Maximizing Energy and Reducing Fatigue in Breast Cancer ... The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BTu00ae is a validated accelerometer ...

6. nature.com nature.com/articles/s41416-025-03129-8

Randomised phase-2 screening trial of intermittent energy ... Weight control and energy restriction could improve survival in patients with advanced breast cancer (ABC) but randomised data are lacking.