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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether online dietary advice and resistance training can help older cancer survivors improve their diet, exercise habits, and physical function. Participants will either receive online nutritional counseling and exercise sessions or just educational materials. The study seeks individuals aged 65 or older who have survived early-stage breast, colorectal, or prostate cancer and experience some physical limitations.

As an unphased trial, this study offers a unique opportunity for participants to contribute to research that may enhance the quality of life for older cancer survivors.

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 prior data suggests that this online dietary and resistance training is safe for older cancer survivors?

Research has shown that online diet and exercise programs for older cancer survivors are generally safe. Studies have adapted these programs to online formats and found that participants handle them well, joining without major problems.

No specific reports of negative effects have emerged from these programs. Instead, they focus on safely improving diet and exercise habits, suggesting that these online programs are quite safe, especially since they are non-invasive and focus on lifestyle changes.

Overall, evidence supports that these online programs provide a safe way to improve physical health and function in older cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Online Dietary and Resistance Training program for older cancer survivors because it combines tailored nutritional advice with structured exercise, all delivered online. This approach is different from the standard care, which often includes in-person consultations and physical therapy sessions. The online format makes it more accessible and convenient, especially for those who may have mobility issues or live far from treatment centers. By integrating both nutrition and exercise, the program aims to improve overall health and quality of life in a holistic way, which is a fresh perspective compared to traditional, more isolated treatments. Additionally, offering educational materials ensures participants are well-informed, empowering them to take charge of their health.

What evidence suggests that online dietary and resistance training is effective for improving physical function in older cancer survivors?

Research shows that online diet and exercise programs can benefit older cancer survivors. In this trial, participants in Arm 1 will engage in online nutritional counseling and resistance training sessions. Studies have found that older adults who join telehealth exercise programs, including strength training, often improve their physical abilities. These programs increase muscle mass and overall health through better protein intake and regular exercise. One study highlighted that these activities during treatment can increase strength and aid recovery. Online programs also simplify access to personalized advice, effectively improving diet and exercise habits. Participants in Arm 2 will receive educational materials to support their health journey. ^{1 3 4 5 6}

Who Is on the Research Team?

Jessica L. Krok-Schoen, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

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E-intervention for Protein Intake and Resistance Training ...

This study will implement and assess the efficacy of the first online dietary and resistance training intervention to improve older cancer ...

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Online Dietary & Resistance Training for Older Cancer ...

This phase I trial tests the feasibility, acceptability, and preliminary effectiveness of online dietary and resistance training to improve physical ...

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Results: Older adults with cancer who chose to participate in the telehealth exercise program (N=68) were 71.8 (SD 5.3) years of age on average ...

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TeleHealth resistance exercise intervention to preserve ...

Two studies suggested that exercise interventions, particularly those incorporating resistance training during chemotherapy could improve RDI in individuals ...

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E-PROOF: E-intervention for protein intake and resistance ...

This study is the first synchronous, online protein-focused diet and resistance training intervention among older cancer survivors. This ...

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Exercise and Nutrition for Older Cancer Survivors ...

This research study will compare the impact of virtually supervised and unsupervised home-based exercise and diet programs on cognitive and physical ...