Web-Based Lifestyle Interventions for Cancer Survivor Health

(AMPLIFY Trial)

Not currently recruiting at 1 trial location

Overseen By Maria Pisu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Progressive cancer, Recurrence, Pregnancy, Dementia, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of interactive online programs designed to help cancer survivors improve their diet, exercise habits, and weight management. The goal is to enhance overall health outcomes, such as physical function, muscle mass, and quality of life, for individuals who have completed primary treatment for certain early-stage cancers. Participants will engage in web-based sessions focusing on diet and exercise. Some groups will alternate emphasis on each for six months, while others will combine both for a year. Individuals diagnosed with specific cancers, who have completed treatment and are not currently in another diet and exercise program, might be a good fit. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve the well-being of future 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. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these web-based lifestyle interventions are safe for cancer survivors?

Research has shown that online lifestyle programs like AMPLIFI are generally safe for cancer survivors. These programs emphasize healthy eating, exercise, and sometimes quitting smoking, activities known to be beneficial with minimal risks.

Previous studies have adapted diet and exercise plans for online use, and middle-aged and older cancer survivors have received them well. Significant reports of negative effects or safety issues have not emerged. In fact, these programs can improve overall health and reduce other health problems.

In summary, the AMPLIFI program aims to support healthy habits safely. While consulting healthcare professionals is always advisable, existing evidence suggests these programs are safe for the intended audience. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-Based Lifestyle Interventions for Cancer Survivor Health trial because it explores how personalized, online support can improve cancer survivors' health through diet and exercise. Unlike traditional face-to-face programs, this approach leverages technology to provide tailored feedback and goal recommendations, making it accessible and adaptable to individual needs. The trial's unique format includes optional participation in a secret Facebook group, fostering a supportive community that can enhance motivation and adherence. By combining diet and exercise interventions in different sequences and formats, the trial aims to identify the most effective strategies for long-term health improvements in cancer survivors.

What evidence suggests that these web-based lifestyle interventions could be effective for cancer survivors?

Research has shown that online programs can help cancer survivors improve their diet, increase exercise, and manage weight. This trial evaluates various web-based lifestyle interventions for cancer survivors. Participants in the "Project 1: Diet-Exercise" arm will focus on diet for 6 months, then exercise for another 6 months. In the "Project 2: Exercise-Diet" arm, participants will focus on exercise first, then diet. Meanwhile, the "Project 3: Combined Diet and Exercise" arm will provide simultaneous diet and exercise content for 12 months. Studies have found that these programs improve diet quality and increase physical activity, which are important for maintaining health. Participants in earlier programs reported better body shape and physical ability. Early results suggest that combining advice on diet and exercise can enhance quality of life and health for cancer survivors. Overall, these programs appear promising for helping cancer survivors maintain long-term health. ^{1 2 4 6 7}

Who Is on the Research Team?

Wendy Demark-Wahnefried, PhD, RD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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 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]

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]

Citations

1. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-022-09519-y

program project protocols for remote lifestyle intervention and ... The main outcomes of the AMPLIFI project are diet quality, physical activity, and weight status. Secondary outcomes include body composition ( ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35488238/

Adapting MultiPLe behavior Interventions that ... - PubMed Scalable, multiple behavior change interventions are needed to address poor diet, inactivity, and excess adiposity among the rising number of cancer survivors.

3. maps.cancer.gov maps.cancer.gov/overview/DCCPSGrants/abstract.jsp?applId=10247730&term=CA229997

Division of Cancer Control & Population Sciences - Grant Details Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) Cancer Survivor Health By 2020, the number of cancer survivors in the US will ...

4. researchgate.net researchgate.net/publication/360277957_Adapting_MultiPLe_behavior_Interventions_that_eFfectively_Improve_AMPLIFI_cancer_survivor_health_program_project_protocols_for_remote_lifestyle_intervention_and_assessment_in_3_inter-related_randomize

Adapting MultiPLe behavior Interventions that eFfectively ... This article describes a pragmatic approach to optimize intervention adaptation of AMPLIFY (AiM, Plan, and act on LIFestYles) web-based diet and exercise ...

5. reporter.nih.gov reporter.nih.gov/search/14EACD094D84C7D77598B8961CAA4A01A2FFCEB861BF/project-details/11192353

Project Details Adapting MultiPLe behavior Interventions that eFfectively Improve (AMPLIFI) Cancer Survivor Health ... Outcome Measurement to Improve Breast Cancer Care ...

6. reporter.nih.gov reporter.nih.gov/project-details/10679027

Adapting MultiPLe behavior Interventions ... - NIH RePORTER It is hypothesized that cancer survivors may be able to improve their overall health and reduce comorbidity through lifestyle modification, particularly since ...

7. withpower.com withpower.com/trial/phase-ovarian-neoplasms-2-2020-fee43

Web-Based Lifestyle Interventions for Cancer Survivor Health The web-based lifestyle interventions, like AMPLIFI, focus on promoting healthy eating, exercise, and smoking cessation, which are generally safe and beneficial ...