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

54 Participants Needed

Trial Summary

What is the purpose of this trial?

To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.

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 data supports the idea that Lifestyle Intervention for Cancer Survivors is an effective treatment?

The available research shows that Lifestyle Intervention for Cancer Survivors can be effective in improving the quality of life and reducing chronic disease risk factors. For example, the study titled 'Comprehensive Lifestyle Modification Intervention to Improve Chronic Disease Risk Factors and Quality of Life in Cancer Survivors' highlights that healthy lifestyle changes, such as managing weight, exercising regularly, eating a balanced diet, and reducing stress, are important for cancer survivors. Another study, 'Multidisciplinary lifestyle modification program (IM-FIT) for cancer survivors,' found that a real-world lifestyle program helped cancer survivors achieve healthy weight loss. These findings suggest that lifestyle interventions can be beneficial for cancer survivors by promoting better health and well-being. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Multimodal Lifestyle Program for cancer survivors?

Research shows that lifestyle changes like weight management, regular exercise, a healthy diet, and stress relief can improve quality of life and reduce chronic disease risks in cancer survivors. These components are part of the Multimodal Lifestyle Program, suggesting it may help cancer survivors live healthier lives. ^{1 2 3 4 5}

What safety data exists for lifestyle interventions in cancer survivors?

The available research on lifestyle interventions for cancer survivors, such as the DUET study and the IM-FIT program, primarily focuses on the effectiveness of these interventions in improving health outcomes like weight loss, physical activity, and diet quality. While these studies highlight the potential benefits of lifestyle interventions, specific safety data is not explicitly detailed in the provided abstracts. However, the studies imply that these interventions are generally safe as they are implemented in real-world settings and involve common lifestyle modifications like diet and exercise. More detailed safety data might be available in the full study reports or through clinical trial registries. ^{2 6 7 8 9}

Is the Lifestyle Intervention for Cancer Survivors safe for humans?

The available research on lifestyle interventions for cancer survivors, including programs like DUET and IM-FIT, suggests they are generally safe. These programs focus on improving diet, increasing physical activity, and promoting healthy weight loss, which are typically safe practices for most people. ^{2 6 7 8 9}

Is the Multimodal Lifestyle Program a promising treatment for cancer survivors?

Yes, the Multimodal Lifestyle Program is promising for cancer survivors. It helps improve quality of life, reduces the risk of chronic diseases, and supports long-term health by encouraging healthy habits like regular exercise, a balanced diet, and stress management. ^{1 10 11 12 13}

How is the Multimodal Lifestyle Program different from other treatments for cancer survivors?

The Multimodal Lifestyle Program is unique because it focuses on comprehensive lifestyle changes, including diet, exercise, stress management, and positive psychology, rather than traditional medical treatments. This approach aims to improve quality of life and reduce the risk of cancer recurrence by empowering survivors with knowledge and skills to adopt healthier habits. ^{1 10 11 12 13}

Research Team

Justin C Brown, PhD

Principal Investigator

Pennington Biomedical Research Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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 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]

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]

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]

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]

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]

References

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

Comprehensive Lifestyle Modification Intervention to Improve Chronic Disease Risk Factors and Quality of Life in Cancer Survivors. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Multidisciplinary lifestyle modification program (IM-FIT) for cancer survivors: implementation of a reimbursable model in a cancer hospital. [2021]

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

Cancer Patients' Long-term Experiences of Participating in a Comprehensive Lifestyle Intervention Study While Receiving Chemotherapy. [2021]

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

Survivorship care plans and adherence to lifestyle recommendations among breast cancer survivors. [2018]

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

Practical clinical interventions for diet, physical activity, and weight control in cancer survivors. [2022]

6. Switzerland 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. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Randomized pilot test of a lifestyle physical activity intervention for breast cancer survivors. [2022]

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

Lifestyle interventions in cancer survivors: designing programs that meet the needs of this vulnerable and growing population. [2023]

9. United States 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. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Lifestyle Interventions for Survivors of Cancer: Usability Study. [2022]

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

Riding the crest of the teachable moment: promoting long-term health after the diagnosis of cancer. [2022]

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

PAVING the Path to Wellness for Breast Cancer Survivors: Lifestyle Medicine Education and Group Interventions. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Lifestyle interventions are feasible in patients with colorectal cancer with potential short-term health benefits: a systematic review. [2023]