Lifestyle Intervention for Cancer Survivors

(Small Steps Trial)

Overseen By Tamara Green

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pennington Biomedical Research Center

Must not be taking: Weight loss drugs

Disqualifiers: Exercise, Weight loss, Surgery, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 10-week lifestyle program can help cancer survivors enhance their heart and lung fitness and better manage their weight. Participants will either follow a special plan with exercise and nutrition guidance or maintain their usual habits for 10 weeks. The trial seeks cancer survivors who have completed their main treatments, such as surgery or chemotherapy, and have a BMI of 30 or higher, or 27 or higher with other weight-related health issues. Participants should not currently engage in regular exercise. As an unphased trial, this study provides a unique opportunity for cancer survivors to contribute to research that could improve post-treatment health and wellness.

Do I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using medications for weight loss, you cannot participate in the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using medications for weight loss, you cannot participate in the trial.

What prior data suggests that this multimodal lifestyle program is safe for cancer survivors?

Research shows that the lifestyle program under testing is safe. In a study with cancer survivors, participants reported no serious side effects. This program includes exercise and nutrition advice over 10 weeks. Another study found that such a program helped people lose weight and improved their heart and lung health without major safety issues. Overall, evidence suggests that participants handle the treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multimodal lifestyle program for cancer survivors because it offers a comprehensive approach that combines intensive behavioral therapy, structured exercise, and nutritional counseling. Unlike traditional cancer survivor treatments that might focus solely on medical or pharmaceutical interventions, this program aims to improve overall health by enhancing cardiorespiratory fitness, which can lead to better long-term outcomes. Furthermore, this holistic strategy empowers patients to actively participate in their recovery process, potentially leading to increased motivation and adherence to healthier lifestyle choices.

What evidence suggests that this multimodal lifestyle program is effective for improving cardiorespiratory fitness and body weight in cancer survivors?

Research has shown that a lifestyle program with multiple approaches can benefit cancer survivors. In this trial, participants in the Multimodal Lifestyle Program will engage in activities like exercise and receive advice on healthy eating. Studies have found that cancer survivors who join such programs often improve their fitness and lose weight compared to those who don't participate. Specifically, one study demonstrated that a year-long exercise program significantly boosted a key measure of fitness, called peak oxygen uptake, in cancer survivors. This evidence suggests that these lifestyle programs can effectively improve health for cancer survivors. Meanwhile, participants in the waitlist control group will maintain their current exercise and dietary habits for the 10-week study period before being offered a similar program. ^{1 2 3 6 7}

Who Is on the Research Team?

Justin C Brown, PhD

Principal Investigator

Pennington Biomedical Research Center

Are You a Good Fit for This Trial?

This trial is for adult cancer survivors who are not currently undergoing active treatment and have no evidence of remaining or returning cancer. Participants should be overweight, with a BMI ≥30 kg/m2 or ≥27 kg/m2 if they also have weight-related health issues. They must not exercise regularly, be pregnant, or have conditions that would make the lifestyle program unsafe.

Inclusion Criteria

I have finished my main cancer treatments but may still be on hormone or targeted therapy.

Ability to provide informed consent before any trial-related activities

I have had cancer before.

Exclusion Criteria

Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks

Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study

Currently pregnant, breastfeeding, or planning to become pregnant within the next 12 weeks

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 10-week multimodal lifestyle program including intensive behavioral therapy, structured exercise training, and nutritional counseling

10 weeks

Weekly visits (in-person)

Waitlist Control

Participants maintain current exercise and dietary habits for 10 weeks, then offered a 4-week lifestyle program

10 weeks

Follow-up

Participants are monitored for changes in cardiorespiratory fitness, body weight, and other health metrics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Lifestyle Program

Trial Overview

The study tests a 10-week multimodal lifestyle program aimed at improving fitness and reducing body weight in cancer survivors. Participants will either start the program immediately or be placed on a waitlist (control group) to compare outcomes between the two groups.

How Is the Trial Designed?

Group I: Multimodal Lifestyle Program Experimental Treatment 1 Intervention

The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. The main objective of the structured exercise training is to improve cardiorespiratory fitness.

Group II: Waitlist Control Active Control 1 Intervention

The waitlist control group will be asked to maintain their current exercise and dietary habits for the 10-week study period. Upon providing study endpoint data at week 10, control group participants will be offered a 4-week multimodal lifestyle program that is similar to the intervention group.

Who Is Running the Clinical Trial?

Pennington Biomedical Research Center

Lead Sponsor

Trials

314

Recruited

183,000+

Published Research Related to This Trial

The AMPLIFY intervention is a web-based program designed to support healthy eating and exercise for older cancer survivors, promoting weight loss and improved diet quality over a structured 48-week period.

Developed using social cognitive theory and incorporating feedback from cancer survivors and experts, the intervention includes interactive e-learning, progress tracking, and social support features, making it a comprehensive resource for behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the TIDieR checklist to describe development and integration of a web-based intervention promoting healthy eating and regular exercise among older cancer survivors. Rogers, LQ., Pekmezi, D., Schoenberger-Godwin, YM., et al.[2023]

A comprehensive lifestyle intervention called Lifestyle 180® led to significant health improvements in 58 cancer survivors over 12 months, including an average weight loss of 14 pounds and reductions in waist circumference and BMI, indicating effective weight management.

Participants also experienced notable improvements in biomarkers related to chronic disease risk, such as decreased triglycerides and fasting insulin levels, along with enhanced quality of life and reduced perceived stress, supporting the importance of lifestyle changes in cancer survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Lifestyle Modification Intervention to Improve Chronic Disease Risk Factors and Quality of Life in Cancer Survivors. Golubić, M., Schneeberger, D., Kirkpatrick, K., et al.[2019]

In a pilot study involving 35 cancer survivors over 2 weeks, participants showed significant engagement with the SurvivorSHINE lifestyle intervention website, averaging 3.2 log-ins and 94 minutes spent on the site, indicating a strong interest in diet and exercise resources.

Increased time spent on the website was positively correlated with improvements in physical activity levels, suggesting that while website use did not directly impact dietary knowledge or weight, it may enhance physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Lifestyle Interventions for Survivors of Cancer: Usability Study. Williams, V., Brown, N., Moore, JX., et al.[2022]

The PAVING the Path to Wellness Program is a 12-week initiative designed for breast cancer survivors, focusing on evidence-based lifestyle medicine to enhance well-being and reduce the risk of cancer recurrence.

Participants in the program reported significant improvements in their attitude and overall well-being, highlighting the program's effectiveness in supporting survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PAVING the Path to Wellness for Breast Cancer Survivors: Lifestyle Medicine Education and Group Interventions. Comander, A., Frates, B., Tollefson, M.[2022]

A 6-month lifestyle intervention for 60 breast cancer survivors significantly improved physical performance, as evidenced by better results in a 6-minute walk task compared to a control group.

The intervention also positively impacted quality of life, particularly in bodily pain and general health, suggesting that simple lifestyle changes can enhance well-being for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized pilot test of a lifestyle physical activity intervention for breast cancer survivors. Basen-Engquist, K., Taylor, CL., Rosenblum, C., et al.[2022]

Cancer survivors, numbering around 25 million, face increased risks for second cancers and other health issues, highlighting the importance of lifestyle factors like diet and exercise in improving their quality of life.

Most cancer survivors express a strong interest in diet and exercise interventions, indicating a need for tailored programs that consider factors like timing and delivery methods to effectively promote long-term behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. Stull, VB., Snyder, DC., Demark-Wahnefried, W.[2023]

The article emphasizes the need for oncologists to incorporate weight management, physical activity, and healthy diet into cancer care, as these factors are crucial for the long-term health of cancer survivors.

It highlights the importance of collaboration between oncology providers and experts in nutrition and exercise to effectively support cancer survivors in making lifestyle changes that can improve their overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical clinical interventions for diet, physical activity, and weight control in cancer survivors. Demark-Wahnefried, W., Rogers, LQ., Alfano, CM., et al.[2022]

A 12-month individualized lifestyle intervention focusing on physical activity, diet, smoking cessation, and stress management was found to be both feasible and desirable for cancer patients undergoing treatment, whether curative or palliative.

While curative patients showed increased motivation and adherence to lifestyle changes, palliative patients experienced a decrease in their perceived ability to follow recommendations, highlighting the need for tailored support based on individual patient circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer Patients' Long-term Experiences of Participating in a Comprehensive Lifestyle Intervention Study While Receiving Chemotherapy. Mikkelsen, HET., Vassbakk-Brovold, K., Antonsen, AJ., et al.[2021]

Lifestyle interventions, particularly physical activity and dietary changes, are feasible for colorectal cancer (CRC) patients and can lead to short-term health improvements, including better dietary quality and enhanced quality of life.

One study indicated that dietary interventions may significantly improve long-term cancer-specific survival, highlighting the potential for lifestyle changes to have lasting benefits for CRC survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle interventions are feasible in patients with colorectal cancer with potential short-term health benefits: a systematic review. Moug, SJ., Bryce, A., Mutrie, N., et al.[2023]

A 12-week multimodal lifestyle program for cancer survivors led to an average weight loss of 3.9% and significant improvements in physical activity, including increased time spent on vigorous exercise and strength training.

Participants also experienced notable reductions in depression, anxiety, and overall distress, indicating that the program positively impacted both physical and mental health, and it was successfully implemented with insurance coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary lifestyle modification program (IM-FIT) for cancer survivors: implementation of a reimbursable model in a cancer hospital. Christie, AJ., Powers-James, C., Narayanan, S., et al.[2021]

Cancer survivors face a higher risk of various health issues, including obesity, cardiovascular disease, and diabetes, and many seek to improve their health through lifestyle changes after diagnosis.

Despite the desire for change, not all survivors adopt healthy behaviors, with only 25% to 42% consuming enough fruits and vegetables, and about 70% of breast and prostate cancer survivors being overweight or obese; oncologists have a crucial role in promoting these lifestyle changes, yet only 20% currently provide such guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Riding the crest of the teachable moment: promoting long-term health after the diagnosis of cancer. Demark-Wahnefried, W., Aziz, NM., Rowland, JH., et al.[2022]

A brief lifestyle consultation as part of a survivorship care plan significantly improved knowledge about healthy diets and physical activity among 126 women with stage 0-III breast cancer at 3 months post-intervention.

While the intervention led to short-term changes in lifestyle behaviors, such as reduced alcohol consumption and increased awareness of dietary supplements, these benefits did not last beyond 6 months, highlighting the need for ongoing support for long-term behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship care plans and adherence to lifestyle recommendations among breast cancer survivors. Greenlee, H., Molmenti, CL., Crew, KD., et al.[2018]

A randomized controlled trial (NCT04132219) is testing a web-based lifestyle intervention called DUET for 56 dyads of cancer survivors and their partners, focusing on improving diet, physical activity, and obesity over six months.

The study shows that web-based interventions are accessible and appealing to cancer survivors, but a significant number (42%) of interested survivors had difficulty finding a support partner, indicating a need for alternative strategies to enhance participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and Methods for a Randomized Controlled Trial of a Dyadic, Web-Based, Weight Loss Intervention among Cancer Survivors and Partners: The DUET Study. Pekmezi, DW., Crane, TE., Oster, RA., et al.[2022]

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