337 Participants Needed

Lifestyle Interventions for Cancer Survivors and High-Risk Individuals

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment Energy Balance Interventions for cancer survivors and high-risk individuals?

Research shows that lifestyle changes focusing on exercise and maintaining a healthy weight can help improve outcomes for cancer survivors. These interventions may reduce the risk of cancer recurrence and improve overall survival by addressing obesity and inactivity, which are linked to poorer cancer outcomes.12345

Is the lifestyle intervention for cancer survivors safe?

Research shows that lifestyle interventions, like exercise and healthy eating, are generally safe for cancer survivors. These interventions can help manage weight and improve overall health without significant safety concerns.12367

How does the lifestyle intervention treatment for cancer survivors differ from other treatments?

This lifestyle intervention treatment is unique because it focuses on promoting exercise, healthy eating, and weight management to improve the health and quality of life of cancer survivors, rather than relying on medications. It aims to address the chronic effects of cancer and improve survivorship outcomes by encouraging behavioral changes, which are not typically part of standard cancer care.12389

What is the purpose of this trial?

This pilot clinical trial studies different types of energy balance interventions to see how well they work in increasing the physical activity levels of breast cancer gene-positive patients, Lynch syndrome-positive patients, chronic lymphocytic leukemia (CLL) survivors or family members of cancer survivors who are at high risk for cancer. Increasing exercise and eating healthy foods may help reduce the risk of cancer. Studying how well different types of interventions work in motivating cancer survivors or high-risk family members to increase exercise and healthy food choices may help doctors plan the most effective motivational program for cancer prevention.

Research Team

Karen M. Basen-Engquist | MD Anderson ...

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.
See 12 more

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Supportive care (energy balance interventions)Experimental Treatment5 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Interventions to promote energy balance and cancer survivorship: priorities for research and care. [2023]
Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement. [2017]
A Mobile System to Improve Quality of Life Via Energy Balance in Breast Cancer Survivors (BENECA mHealth): Prospective Test-Retest Quasiexperimental Feasibility Study. [2020]
Helping Patients Eat Better During and Beyond Cancer Treatment: Continued Nutrition Management Throughout Care to Address Diet, Malnutrition, and Obesity in Cancer. [2020]
The role of obesity in cancer survival and recurrence. [2022]
Energy balance in cancer survivors at risk of weight gain: a review. [2023]
Impact of a behavioral weight loss intervention on comorbidities in overweight and obese breast cancer survivors. [2018]
Promoting health and physical function among cancer survivors: potential for prevention and questions that remain. [2016]
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. [2023]
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