Lifestyle Interventions for Cancer Survivors and High-Risk Individuals

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Recent surgery, Radiation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help cancer survivors and individuals at high risk for cancer increase physical activity and make healthier food choices. The researchers aim to determine which methods, such as telephone coaching or daily text messages, most effectively motivate these individuals to adopt healthier lifestyles. These methods are part of Energy Balance Interventions, which focus on balancing calorie intake with physical activity. Suitable participants have a body mass index (BMI) of 25 or higher, exercise infrequently, or consume fewer than five servings of fruits and vegetables daily. Participants must also have a cell phone for text messages and internet access.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance lifestyle interventions for cancer prevention and survivorship.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving radiation therapy or cytotoxic chemotherapy, you are not eligible to participate.

What prior data suggests that these energy balance interventions are safe?

Research shows that activities like exercise and healthy eating are generally manageable for participants. Studies have found that these activities can help cancer survivors improve fitness and manage weight. For instance, cancer survivors who joined these programs performed better in walking tests and maintained healthier body weight and muscle. Reports of negative effects from these activities are rare, suggesting they are safe for cancer survivors or those at high risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to help cancer survivors and those at high risk improve their lifestyle habits. Unlike traditional treatments that focus solely on medical interventions, this approach combines telephone or email coaching, daily text reminders, social networking, and self-monitoring to promote healthier behaviors. These strategies aim to make sustainable lifestyle changes more achievable and personalized, potentially leading to better long-term outcomes. By integrating digital tools and social support, this method could offer a more adaptable and engaging way to support individuals in managing their health.

What evidence suggests that these energy balance interventions are effective for increasing physical activity levels in cancer survivors and high-risk individuals?

Research shows that activities like regular exercise and healthy eating can improve the health of cancer survivors and those at high risk. Studies have found that these activities lower cancer risk and enhance life quality after cancer. For instance, exercise reduces cancer-related tiredness and improves cancer patients' quality of life. This trial will evaluate various energy balance interventions, such as telephone or email coaching, text messages, social networking, and self-monitoring, to encourage healthier lifestyle choices. These healthy habits are especially beneficial during and after cancer treatment, particularly for those with stomach or intestinal cancers. Overall, these strategies may reduce cancer risk. ^{1 2 6 7 8}

Who Is on the Research Team?

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for breast cancer gene-positive, Lynch syndrome-positive individuals, CLL survivors or high-risk family members. Participants must be able to exercise moderately, read/write English, have internet access and a cell phone capable of texting. They should have a BMI of 25+ or low physical activity/fruit-vegetable intake.

Inclusion Criteria

I am a relative of someone with BRCA or Lynch syndrome.

I have felt very tired in the last week.

I am positive for BRCA mutation or Lynch syndrome.

Exclusion Criteria

I need help from devices like crutches or a walker to walk.

I am currently undergoing radiation therapy or chemotherapy.

I had surgery less than 3 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive energy balance interventions including telephone or email coaching, text messages, social networking, and self-monitoring for 16 weeks

16 weeks

Weekly interactions (telephone or email), daily text messages

Follow-up

Participants are monitored for changes in waist circumference and other outcomes after the intervention

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Energy Balance Interventions

Trial Overview The study tests energy balance interventions like dietary changes, online programs, lab biomarker analysis, phone calls and questionnaires to see if they increase physical activity and healthy eating in participants at risk for cancer.

How Is the Trial Designed?

Group I: Supportive care (energy balance interventions) Experimental Treatment 5 Interventions

TELEPHONE COACHING VS EMAIL COACHING: Participants receive telephone coaching once per week for 16 weeks or 1 email per week for 16 weeks (with follow-up responses if the participant responds) from a coach trained in motivational interviewing. TEXT MESSAGES: Participants receive daily text messages promoting adherence to diet and exercise recommendations daily 1-3 times per day or no text messages. SOCIAL NETWORKING: Participants are invited to an online forum for study participants available for 16 weeks or do not receive an invitation for social networking. SELF-MONITORING: Participants are asked to record their dietary intake 4-7 days per week or 1 day per week on a website or smartphone app.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

This systematic review analyzed 11 randomized controlled trials (RCTs) focused on theory-based lifestyle interventions for weight loss in breast cancer survivors, finding that 7 of these trials were classified as 'very promising' in their effectiveness to reduce body weight by at least 5%.

The most commonly used theoretical framework was Social Cognitive Theory, and all interventions included key behavioral change techniques such as goal setting and self-monitoring, which are crucial for successful weight management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying the effective behaviour change techniques in nutrition and physical activity interventions for the treatment of overweight/obesity in post-treatment breast cancer survivors: a systematic review. Perperidi, M., Saliari, D., Christakis, C., et al.[2023]

Interventions promoting exercise and healthy body weight are increasingly recognized as important for improving the long-term health of cancer survivors, addressing issues like obesity and physical inactivity.

The review highlights differences in research and clinical priorities between Europe and North America regarding energy balance interventions, suggesting a need for international collaboration to enhance care and outcomes for post-treatment cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to promote energy balance and cancer survivorship: priorities for research and care. Alfano, CM., Molfino, A., Muscaritoli, M.[2023]

Cancer patients and survivors often face poor nutritional intake, which can lead to malnutrition, loss of lean body mass, and excessive weight loss during and after treatment, negatively impacting their clinical outcomes.

Obesity is common among cancer patients and can mask malnutrition, posing additional risks for cancer recurrence and survival; thus, effective nutritional education and targeted lifestyle interventions are crucial for improving adherence to dietary guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping Patients Eat Better During and Beyond Cancer Treatment: Continued Nutrition Management Throughout Care to Address Diet, Malnutrition, and Obesity in Cancer. Greenlee, H., Santiago-Torres, M., McMillen, KK., et al.[2020]

Citations

1. bmcnurs.biomedcentral.com bmcnurs.biomedcentral.com/articles/10.1186/s12912-023-01363-0

Effects of exercise interventions on cancer-related fatigue and ... In this study, exercise interventions were evaluated for their effects on cancer-related fatigue (CRF) and quality of life (QoL) among cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3671486/

Interventions to Promote Energy Balance and Cancer ... We review the randomized, controlled trials targeting nutrition, exercise, and weight to affect survivorship outcomes.

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.28062

Interventions to promote energy balance and cancer ... In this article, the authors describe the similarities and differences in research and clinical priorities related to energy balance ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e23017

Representation in clinical trials evaluating lifestyle ... Conclusions: Most of the lifestyle intervention trials focused on breast cancer survivors (51%). Despite rising rates of cancer in women under ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6500387/

Energy balance and gastrointestinal cancer: risk, interventions ... Energy balance interventions, such as caloric restriction or exercise, have demonstrated benefits both during and after treatment for patients with ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1040842824003457

Grading the evidence for physical activity and any outcome ... Despite these data, in 2020, 35.5 % of cancer survivors in the United States, aged 18 years and older, reported no physical activity in their leisure time (" ...

7. academic.oup.com academic.oup.com/jnci/article/108/1/djv285/2457748

NCI Funding Trends and Priorities in Physical Activity and ... This paper presents trends over the past decade of the National Cancer Institute (NCI) research portfolio, fiscal year 2004 to 2014, by funding mechanism, ...

8. mdpi.com mdpi.com/2072-6643/13/12/4460

Healthy Moves to Improve Lifestyle Behaviors of Cancer ... The CB survivors showed significant improvements on the 6-min walk and 2-min step tests, body weight, and fat and F and V consumption.