~204 spots leftby Sep 2027

Nutrition and Exercise Program for Cancer Survivors

(OnPoint Trial)

Recruiting in Palo Alto (17 mi)
Overseen ByTracy E Crane, PhD, RDN
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Miami
Disqualifiers: Dementia, Psychiatric disease, Stroke, others
No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to see if survivors of breast, prostate, or colorectal cancer who receive a personal referral to a targeted nutrition and exercise program will be able to eat a healthier diet and be more physically activity.
Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor.

What data supports the effectiveness of the treatment OnPoint for cancer survivors?

Research shows that combining exercise and nutrition can help cancer survivors by reducing muscle and bone loss, improving physical and psychological health, and minimizing treatment side effects. These approaches are recommended for cancer care and can improve overall outcomes for survivors.

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Is the Nutrition and Exercise Program for Cancer Survivors safe for humans?

The Nutrition and Exercise Program for Cancer Survivors, including variations like OnPoint, has been shown to be safe for cancer survivors, with studies indicating no significant safety concerns and potential benefits such as improved muscle mass and quality of life.

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How is the OnPoint treatment different from other treatments for cancer survivors?

The OnPoint treatment is unique because it combines personalized nutrition and exercise programs specifically designed for cancer survivors, focusing on improving energy balance and reducing the chronic effects of cancer. Unlike standard treatments, it emphasizes individualized interventions to enhance prognosis and survivorship outcomes through tailored diet and physical activity plans.

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Eligibility Criteria

This trial is for survivors of breast, prostate, or colorectal cancer. Participants should be interested in improving their diet and physical activity with the help of professionals like dietitians and exercise physiologists.

Inclusion Criteria

I am willing to participate in a 60-90 minute interview.
Healthcare Providers: Provide full- or part-time care in an oncology clinical care setting at Sylvester Comprehensive Cancer Center
Patients: Agree to be randomly assigned to any study group
+7 more

Exclusion Criteria

I cannot read or understand English or Spanish.
Any contraindication for diet change or exercising as determined by physician
Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month
+8 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a targeted nutrition and exercise program based on their assigned complexity group

8 weeks

Follow-up

Participants are monitored for dietary and physical activity changes after the intervention

4 weeks

Participant Groups

The OnPoint trial tests if a personalized program including nutrition courses, prescriptions, weekly sessions with a dietitian and an exercise physiologist, plus monitoring through Fitbit can improve the health habits of cancer survivors.
4Treatment groups
Experimental Treatment
Active Control
Group I: Moderate Complexity GroupExperimental Treatment5 Interventions
Participants in this group will receive the moderate complexity intervention for up to eight (8) weeks.
Group II: Low Complexity GroupExperimental Treatment3 Interventions
Participants in this group will receive the low complexity intervention for up to eight (8) weeks.
Group III: High Complexity GroupExperimental Treatment5 Interventions
Participants in this group will receive the high complexity intervention for up to eight (8) weeks.
Group IV: Control GroupActive Control1 Intervention
Participants randomized to this arm will receive routine care and will not receive any study materials until the end of the study at 24 weeks.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of MiamiMiami, FL
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Who Is Running the Clinical Trial?

University of MiamiLead Sponsor
The Applebaum FoundationCollaborator

References

Exercise and Nutritional Approaches to Combat Cancer-Related Bone and Muscle Loss. [2021]The aim of this narrative review is to summarise recent literature on the effects of exercise and nutrition interventions alone or in combination on muscle and bone loss in people with cancer.
Supportive Care in Oncology-From Physical Activity to Nutrition. [2022]The diagnosis and treatment of cancer are associated with impairment at the physical and at psychological level. In addition, side effects are a potentially treatment-limiting factor that may necessitate dose reduction, delay, or even discontinuation of therapy, with negative consequences for outcome and mean survival. Numerous studies have shown that physical activity and sports and exercise therapy programs are not only practicable but also recommendable for oncologic patients during the acute phase and in the aftercare. Furthermore, nutrition plays an important role in all stages of tumor therapy. A timely integration of a nutrition therapy and physical activity in the form of physiotherapy and sports therapy serves to prevent and reduce treatment-associated side effects. Evidence-based recommendations on cancer prevention through nutrition therapy, physical activity, and sports and exercise therapy should be integrated into treatment plans for oncology patients as well as in health care services for the general population. Individual counselling by trained nutrition and exercise specialists may be advisable to receive concrete recommendations on the respective tumor entity or specific side effects. This mini review is based on a selective literature search in the PubMed database and Cochrane Central Register of Controlled Trials on the subjects of healthy diet and physical activity in primary prevention and follow-up about cancer.
Interventions to promote energy balance and cancer survivorship: priorities for research and care. [2023]The growing population of cancer survivors worldwide and the growing epidemics of obesity and physical inactivity have brought increased attention to the role that interventions to promote exercise and a healthy body weight may play in mitigating the chronic and late effects of cancer. In this light, the authors describe the similarities and differences in research and clinical priorities related to energy balance interventions among post-treatment cancer survivors in Europe versus North America. Randomized controlled trials that targeted nutrition, exercise, and weight are reviewed to determine the affect on survivorship outcomes. Interventions focused on improving prognosis or survival are investigated along with the emerging literature on the interventions targeting pathways and mechanisms of prognosis or survival. Current North American and European guidelines for diet, exercise, and weight control among cancer survivors also are investigated along with the implications of the current state of this science for clinical care. Finally, the authors delineate future European and American priorities for research and care involving energy balance among survivors. It is hoped that this dialogue launches an international conversation that will lead to better research and care for all post-treatment cancer survivors.
Randomized pilot test of a simultaneous stage-matched exercise and diet intervention for breast cancer survivors. [2022]To investigate the feasibility and preliminary effects of a simultaneous stage-matched exercise and diet (SSED) intervention in breast cancer survivors.
Essential elements of optimal dietary and exercise referral practices for cancer survivors: expert consensus for medical and nursing health professionals. [2022]To develop and establish expert consensus on essential elements of optimal dietary and exercise referral practices for cancer survivors.
A Pilot Study of Self-Management-based Nutrition and Physical Activity Intervention in Cancer Survivors. [2018]Exercise and a healthy diet are beneficial after cancer, but are not uniformly adopted by cancer survivors. This study reports on the feasibility, acceptability, and effectiveness of a self-management-based nutrition and exercise intervention for Australian cancer survivors. Adult survivors (n = 25) during curative chemotherapy (stratum 1[S1]; n = 11) or post-treatment (stratum 2 [S2]; n = 14) were recruited prospectively from a single center. The Flinders Living Well Self-Management Program™ (FLW Program) was utilized to establish patient-led nutrition and exercise goals and develop a tailored 12-wk intervention plan. Fortnightly reviews occurred with assessments at baseline, 6 and 12 wk. A recruitment and retention rate of 38% and 84% were observed. Both strata maintained total skeletal muscle mass. Small reductions in body mass index, hip circumference, and percentage body fat, and small increases in hand grip strength and exercise capacity among subjects in both strata were observed. No significant differences were observed between strata; however, significant increases in exercise capacity and global health status for S2 were observed from baseline to 12 wk. FLW Program is a feasible mode of delivering nutrition and exercise intervention to cancer survivors and it appears that there are no barriers to implementing this program early during chemotherapy. Hence, the additive effect of gains achieved over a longer duration is promising and this should be explored in randomized controlled trials adequately powered to observe clinically and statistically significant improvements in relevant outcomes.
[Nutrition and physical activity (PA) during and after cancer treatment: Therapeutic benefits, pathophysiology, recommendations, clinical management]. [2022]Lifestyle behaviors, such as diet and physical activity, are factors that influence risk of numerous cancers. They are also decisive during and after cancer for the course of oncological treatment, but also in the immediate and long-term prognosis, and quality of life during and after treatment. Separately, physical activity and nutritional support can reduce the risk of sarcopenia and its consequences, and improve quality of life during treatment. Whan introduced early, such a combination, increases the prognostic benefits. In remission, particularly in overweight patients, the APA-diet combination reduces the risk of cancer relapse and improves cardiovascular performance. These programs require a precise assessment of capacities and habits of each patient, and interventions of trained professionals (certified exercise instructor, dietician trained in oncology). The funding conditions for these programs exist for cancer survivors and should be considered for oncological treatment period.
Examining guidelines and new evidence in oncology nutrition: a position paper on gaps and opportunities in multimodal approaches to improve patient care. [2022]Malnutrition, muscle loss, and cachexia are prevalent in cancer and remain key challenges in oncology today. These conditions are frequently underrecognized and undertreated and have devastating consequences for patients. Early nutrition screening/assessment and intervention are associated with improved patient outcomes. As a multifaceted disease, cancer requires multimodal care that integrates supportive interventions, specifically nutrition and exercise, to improve nutrient intake, muscle mass, physical functioning, quality of life, and treatment outcomes. An integrated team of healthcare providers that incorporates societies' recommendations into clinical practice can help achieve the best possible outcomes. A multidisciplinary panel of experts in oncology, nutrition, exercise, and medicine participated in a 2-day virtual roundtable in October 2020 to discuss gaps and opportunities in oncology nutrition, alone and in combination with exercise, relative to current evidence and international societies' recommendations. The panel recommended five principles to optimize clinical oncology practice: (1) position oncology nutrition at the center of multidisciplinary care; (2) partner with colleagues and administrators to integrate a nutrition care process into the multidisciplinary cancer care approach; (3) screen all patients for malnutrition risk at diagnosis and regularly throughout treatment; (4) combine exercise and nutrition interventions before (e.g., prehabilitation), during, and after treatment as oncology standard of care to optimize nutrition status and muscle mass; and (5) incorporate a patient-centered approach into multidisciplinary care.
An individualized food-based nutrition intervention reduces visceral and total body fat while preserving skeletal muscle mass in breast cancer patients under antineoplastic treatment. [2021]Breast cancer patients (BCP) during treatment often experience an increase in body weight and fat mass, and a decrease in muscle mass known as sarcopenic obesity, affecting their prognosis and quality of life. We aimed to evaluate the effect of a 6-month individualized food-based nutrition intervention program in nonmetastatic BCP body composition during treatment.