Online Dietary & Resistance Training for Older Cancer Survivors

(E-PROOF Trial)

Overseen By The Ohio State Comprehensive Cancer Center

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Cancer treatment, Liver/renal disease, Protein supplements, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

70 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those currently receiving cancer treatment or under the care of a dietitian.

What data supports the effectiveness of the treatment Online Dietary and Resistance Training for older cancer survivors?

Research shows that exercise, including resistance training, can improve muscle strength and body composition in cancer survivors. Additionally, combining exercise with dietary advice can enhance muscle mass and physical functioning in older cancer survivors. ^{1 2 3 4 5}

Is online dietary and resistance training safe for older cancer survivors?

Research on online dietary and resistance training for cancer survivors suggests it is generally safe, as studies have transitioned to online formats during COVID-19 and explored feasibility and safety, although specific safety data for older cancer survivors is limited. ^{6 7 8 9 10}

How is the Online Dietary and Resistance Training treatment different from other treatments for older cancer survivors?

This treatment is unique because it combines online dietary guidance with live, online resistance training sessions, making it accessible for older cancer survivors who may have mobility issues or prefer to stay at home. Unlike traditional in-person exercise programs, this approach leverages video-conferencing technology to deliver supervised group exercise, which was adapted during COVID-19 to maintain safety and accessibility. ^{1 6 9 11 12}

What is the purpose of this trial?

This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical function in older (greater than or equal to 65-years old) cancer survivors. Declines in adequate protein and calorie intake results in faster loss of muscle mass and physical functioning in older adults. A novel approach to improving physical function in older cancer survivors (OCS) is to utilize online, tailored education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein intake, diet quality) and participation in resistance exercise. The purpose of this study is to help researchers learn whether an online dietary and resistance training intervention improves diet, exercise, physical function, and health outcomes in OCS.

Research Team

Jessica L. Krok-Schoen, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for older cancer survivors (65+ years) who've had stage I-III breast, colorectal, or prostate cancer and finished treatment. They must have some physical function limitations but no progressive disease or other cancers. It's not for those on current cancer treatments, with liver/renal issues affecting protein intake, under a dietitian's care, in other diet/exercise studies, or unable to exercise without help.

Inclusion Criteria

I am 65 years old or older.

You have reported having at least one physical limitation on the RAND-36 Physical Function Subscale, such as being limited a little or a lot in your abilities.

My cancer is in the early to mid stages and is either breast, colorectal, or prostate cancer.

Exclusion Criteria

I am currently undergoing cancer treatment.

I must limit my protein intake due to liver or kidney disease.

Using protein supplements.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week online dietary and resistance training intervention, including nutritional counseling and resistance training sessions

12 weeks

Online sessions in weeks 1-6 and biweekly in weeks 8, 10, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Online Dietary and Resistance Training

Trial Overview The E-PROOF Trial tests an online program combining dietary guidance from dietitians and resistance training led by exercise scientists to see if it improves the physical function of older cancer survivors. The focus is on enhancing protein intake and quality of diet while engaging participants in home-based exercises.

Participant Groups

Group I: Arm 1 (nutritional counseling, resistance training) Experimental Treatment 6 Interventions

Patients participate in online nutritional counseling over 30 minutes in weeks 1, 3, 5, 7, 9, and 11, and participate in online resistance training sessions weekly over 30 minutes in weeks 1-6 and biweekly at weeks 8, 10, and 12. Patients also receive educational materials at baseline.

Group II: Arm 2 (educational materials) Active Control 4 Interventions

Patients receive educational materials at baseline.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Interventions promoting exercise and healthy body weight are increasingly recognized as important for improving the long-term health of cancer survivors, addressing issues like obesity and physical inactivity.

The review highlights differences in research and clinical priorities between Europe and North America regarding energy balance interventions, suggesting a need for international collaboration to enhance care and outcomes for post-treatment cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to promote energy balance and cancer survivorship: priorities for research and care. Alfano, CM., Molfino, A., Muscaritoli, M.[2023]

The AMPLIFI study is testing web-based diet and exercise interventions for middle-aged and older cancer survivors, focusing on improving health behaviors and reducing obesity-related risks through three randomized controlled trials involving multiple behavior change strategies.

The study will assess the efficacy of sequential versus simultaneous interventions over a 2-year period, measuring various health outcomes such as body mass index, physical activity, and muscle mass, using remote technologies for recruitment and assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. Pekmezi, D., Fontaine, K., Rogers, LQ., et al.[2023]

Mobile health (mHealth) diet interventions significantly improved dietary habits in cancer survivors, increasing fruit and vegetable intake and reducing fat intake, while also leading to weight loss and reductions in waist and hip circumference, based on a review of 15 randomized controlled trials involving 2363 participants.

These interventions also positively impacted the quality of life for cancer survivors, indicating that mHealth strategies could be an effective approach for dietary management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mHealth diet interventions in cancer survivors: A systematic review and meta-analysis of randomized controlled trials. Gong, Y., Jiang, X., Chen, X., et al.[2023]

Resistance training (RT) significantly improves muscular strength in elderly cancer patients, with a strong effect size of 0.87 based on a review of 13 studies involving 717 participants.

However, RT does not significantly increase muscle hypertrophy, indicating that while strength gains are achievable, increases in muscle size may not occur in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of resistance training on muscular strength and hypertrophy in elderly cancer patients: A systematic review and meta-analysis. Lee, J.[2022]

References

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

The effects of exercise with or without dietary advice on muscle mass, muscle strength, and physical functioning among older cancer survivors: a meta-analysis of randomized controlled trials. [2023]

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

Interventions to promote energy balance and cancer survivorship: priorities for research and care. [2023]

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

Impact of resistance training in cancer survivors: a meta-analysis. [2022]

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

Protein Supplementation and Resistance Training in Childhood Cancer Survivors. [2022]

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

Interventions to Improve Bone Mineral Density, Muscle Mass and Fat Mass among Breast Cancer Survivors. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Delivering exercise medicine to cancer survivors: has COVID-19 shifted the landscape for how and who can be reached with supervised group exercise? [2022]

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

Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) cancer survivor health: program project protocols for remote lifestyle intervention and assessment in 3 inter-related randomized controlled trials among survivors of obesity-related cancers. [2023]

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

Evaluation of a web-based weight loss intervention in overweight cancer survivors aged 50 years and younger. [2021]

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

The feasibility and efficacy of eccentric exercise with older cancer survivors: a preliminary study. [2021]

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

Effectiveness of mHealth diet interventions in cancer survivors: A systematic review and meta-analysis of randomized controlled trials. [2023]

11. China pubmed.ncbi.nlm.nih.gov

The effects of resistance training on muscular strength and hypertrophy in elderly cancer patients: A systematic review and meta-analysis. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Eccentric exercise versus usual-care with older cancer survivors: the impact on muscle and mobility--an exploratory pilot study. [2021]