Web-Based Lifestyle Interventions for Cancer Survivor Health

(AMPLIFY Trial)

Recruiting at 1 trial location

Overseen By Maria Pisu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

603 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study will test the efficacy of interactive, web-based interventions that improve diet, physical activity and weight management changes among early stage survivors of breast, prostate, colorectal, endometrial, renal, thyroid, and ovarian cancers, as well as multiple myeloma and non-Hodgkin Lymphoma. Overarching outcomes also include physical function and performance, muscle mass, quality of life, and health utilities.

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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment AMPLIFI for cancer survivor health?

The AMPLIFI treatment, which includes diet and exercise programs adapted for web delivery, is based on previously tested programs that have shown effectiveness in improving diet and physical activity among cancer survivors. These interventions aim to help cancer survivors lose weight, improve diet quality, and meet exercise recommendations, which are important for enhancing quality of life and reducing cancer recurrence risk. ^{1 2 3 4 5}

Is the web-based lifestyle intervention for cancer survivors safe?

The web-based lifestyle interventions, like AMPLIFI, focus on promoting healthy eating, exercise, and smoking cessation, which are generally safe and beneficial for improving overall health and quality of life in cancer survivors. ^{1 2 3 6 7}

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

The AMPLIFI treatment is unique because it is a web-based program specifically designed to help cancer survivors improve their health through lifestyle changes like healthy eating and regular exercise. Unlike traditional treatments, it focuses on multiple behavior changes and is delivered remotely, making it accessible to a wide range of survivors. ^{1 2 3 6 8}

Research Team

Wendy Demark-Wahnefried, PhD, RD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for early-stage cancer survivors over 50, living in the US with a BMI of 25-50 kg/m2 and less than 150 minutes of exercise per week. They must have finished primary treatment, not be in another diet-exercise program, or have progressive/recurrent cancer. Those with severe health conditions that limit physical activity are excluded.

Inclusion Criteria

You are able to read and write English.\n

I have finished my main cancer treatment or am on active surveillance for prostate cancer or ductal carcinoma in situ.

Reside in an area that receives wireless coverage

Exclusion Criteria

I do not have any health conditions that would stop me from following a weight loss plan on my own.

My cancer has come back, but it's not just a rise in prostate cancer markers.

Reside in a skilled nursing or assisted living facility

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive web-based interventions focusing on diet and exercise, with different sequences depending on the study arm

12 months

Evaluations at baseline, 6-, 12-, and 18-months

Follow-up

Participants are monitored for changes in weight, physical activity, and quality of life

6 months

Treatment Details

Interventions

• Adapting MultiPLe Behavior Interventions That eFfectively Improve (AMPLIFI) Cancer Survivor Health

Trial Overview The AMPLIFI Cancer Survivor Health study tests web-based interventions to improve diet and exercise among survivors of various cancers. It aims to see if these programs can enhance physical function, muscle mass, quality of life, and overall health.

Participant Groups

Group I: Project 3: Combined Diet and Exercise Experimental Treatment 3 Interventions

Participants will receive the diet and exercise content simultaneously in combined web-based sessions. Participants will receive and participate in web-based sessions that focus on diet and exercise for 12 months. Participants will be encouraged to track their diet, weight and physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

Group II: Project 2: Exercise-Diet Experimental Treatment 2 Interventions

Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

Group III: Project 1: Diet-Exercise Experimental Treatment 2 Interventions

Participants will receive and participate in web-based sessions that focus on diet for 6 months, followed by exercise for another 6 months. Participants will be encouraged to track their diet and weight for the first 6 months and to log their data in the intervention website, during the second 6 months they will be asked to log their physical activity data (minutes and step counts). Tailored feedback and goal recommendations will be provided through the website. Participants will also receive access to resources for relevant behavioral topics. All participants will be invited to participate in the secret Facebook group for the project (though participation is optional).

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of Tennessee

Collaborator

Trials

202

Recruited

146,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

University of Tennessee Health Science Center

Collaborator

Trials

49

Recruited

24,600+

Findings from Research

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]

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]

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 BEAT Cancer intervention significantly improved key social cognitive factors such as self-efficacy, goal setting, and perceived barriers to physical activity among 222 post-treatment breast cancer survivors over a 3-month period.

Despite these improvements in social cognitive constructs, the intervention did not lead to significant indirect effects on increasing physical activity levels measured 6 months after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis. Rogers, LQ., Courneya, KS., Anton, PM., et al.[2021]

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]

Cancer survivors face increased risks for various health issues, including recurrent cancer and chronic diseases, highlighting the importance of lifestyle interventions to improve their overall health and quality of life.

A review of numerous studies indicates that while many lifestyle interventions (like exercise, diet changes, and smoking cessation) have shown success in promoting healthier behaviors, further research is needed to identify the most effective components of these interventions for maximizing health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting health and physical function among cancer survivors: potential for prevention and questions that remain. Demark-Wahnefried, W., Pinto, BM., Gritz, ER.[2016]

A systematic review of 10 studies found that multiple health behavior change (MHBC) interventions effectively improved diet, exercise, and smoking cessation among adult cancer survivors and those at high risk for cancer.

In-person interventions were particularly effective, and longer-duration interventions that utilized phone or mail contact showed a positive impact on changing diet and exercise behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple health behavior change in adults with or at risk for cancer: a systematic review. Green, AC., Hayman, LL., Cooley, ME.[2018]

References

1. 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]

2. 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]

3. Canada pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Long-term effects of a web-based cancer aftercare intervention on moderate physical activity and vegetable consumption among early cancer survivors: a randomized controlled trial. [2022]

6. 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]

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

Promoting health and physical function among cancer survivors: potential for prevention and questions that remain. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Multiple health behavior change in adults with or at risk for cancer: a systematic review. [2018]