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

Trial Summary

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 data supports the effectiveness of the treatment for fatigue after breast cancer?

Research shows that energy conservation strategies and health promotion can reduce cancer-related fatigue in breast cancer survivors, with improvements lasting for at least 8 weeks after the intervention. ^{1 2 3 4 5}

Is the Maximizing Energy Program for Fatigue After Breast Cancer safe for humans?

The available research suggests that lifestyle interventions, including diet and exercise programs similar to the Maximizing Energy Program, are generally safe for breast cancer survivors. These interventions have been shown to improve quality of life and are well-tolerated, although their effectiveness in reducing fatigue specifically may vary. ^{1 3 4 6 7}

How does the Maximizing Energy treatment differ from other treatments for fatigue after breast cancer?

The Maximizing Energy treatment is unique because it focuses on energy conservation strategies, which involve teaching patients how to manage their energy levels effectively to reduce fatigue. This approach is different from other treatments that may focus solely on physical activity or medication, as it includes personalized strategies like relaxation and meditation to help manage fatigue. ^{2 8 9 10 11}

What is the purpose of this trial?

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.

Research Team

Ketki Raina, PhD, OTR/L, FAOTA

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adherence, sleep, and fatigue outcomes after adjuvant breast cancer chemotherapy: results of a feasibility intervention study. [2015]

2. Thailand pubmed.ncbi.nlm.nih.gov

Effects of Energy Conservation Strategies on Cancer Related Fatigue and Health Promotion Lifestyle in Breast CancerSurvivors: a Randomized Control Trial [2019]

3. Switzerland 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Associations between fatigue and cellular metabolism in breast cancer patients: A longitudinal study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Nutritional Interventions for Treating Cancer-Related Fatigue: A Qualitative Review. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Diet components associated with perceived fatigue in breast cancer survivors. [2021]

8. United States 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. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Determinants of physical, affective, and cognitive fatigue during breast cancer therapy and 12 months follow-up. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Managing post-therapy fatigue for cancer survivors using energy conservation training. [2009]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

How fatigue affects return to work in breast cancer patients. [2022]