Health Behavior Intervention for Cancer Risk Reduction in BRCA/Lynch Syndrome Families

Overseen By Karen M Basen-Engquist

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

384 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well weight management and health behavior intervention works in helping patients with hereditary breast and ovarian cancer and Lynch syndrome mutation carriers lose or maintain a healthy weight and lower their risk for cancer. Lifestyle behaviors such as physical activity, diet, and weight management may play a key role in preventing cancers and improving outcomes even in those with hereditary cancer syndromes.

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 for cancer risk reduction in BRCA/Lynch Syndrome families?

Research suggests that knowledge about cancer prevention recommendations is crucial for adherence to healthy lifestyle changes, such as physical activity and diet, which are part of the treatment. Increasing awareness and education about these recommendations can improve adherence and potentially reduce cancer risk in Lynch Syndrome patients. ^{1 2 3 4 5}

How does the Health Promotion and Education treatment differ from other treatments for cancer risk reduction in BRCA/Lynch Syndrome families?

The Health Promotion and Education treatment is unique because it focuses on increasing knowledge and adherence to lifestyle recommendations, such as diet and physical activity, to reduce cancer risk, rather than using medication or surgical interventions. This approach emphasizes behavior change and education to empower individuals with Lynch Syndrome to adopt healthier lifestyles, which is different from traditional medical treatments. ^{1 2 3 4 5}

Research Team

Karen M. Basen-Engquist

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for individuals with hereditary breast, ovarian cancer or Lynch syndrome who are overweight, inactive, eat less than 5 servings of fruits and veggies per day, and live near MD Anderson's main campus. It's not for pregnant/nursing women, those at high cancer risk, previous study participants, people undergoing certain cancer treatments or unable to walk unassisted.

Inclusion Criteria

HEALTH4CPC only: Lives in the Houston area or surrounding counties (within 150 miles of MD Anderson's main campus)

Access to internet via desktop or mobile device

I or a family member have a mutation linked to breast or colorectal cancer.

Exclusion Criteria

Does not live in the United States

I have been diagnosed with cancer, excluding non-melanoma skin cancer.

I had major surgery less than 3 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo weight management and health behavior intervention with a combination of 4 components for 16 weeks

16 weeks

Weekly phone calls or emails, regular text messages, and self-monitoring

Follow-up

Participants are monitored for weight loss, physical activity, and dietary changes after the intervention

4 months

Follow-up assessments at 4 and 8 months

Treatment Details

Interventions

• Behavioral Dietary Intervention
• E-mail
• Exercise Intervention
• Health Promotion and Education
• Internet-Based Intervention
• Questionnaire Administration
• Telephone-Based Intervention
• Text Message

Trial Overview The trial tests a weight management program that includes exercise routines, online resources via email and internet platforms, dietary guidance through behavioral interventions along with health education. Participants will also complete questionnaires and receive support over the phone.

Participant Groups

Group I: Prevention (weight management, health behavior intervention) Experimental Treatment 7 Interventions

Participants undergo weight management and health behavior intervention with a combination of 4 components for 16 weeks. TELEPHONE COACHING: Participants receive 1 phone call each week from a coach over 30-45 minutes to discuss diet, physical activity and goal setting. EMAIL COACHING: Participants receive 1 phone call to discuss the process over 10-15 minutes and then receive 1 email each week for 16 weeks. NO COACHING: Participants receive 1 phone call the first week over 10-15 minutes to discuss the process. TEXT MESSAGING: Participants receive 7-12 text messages comprising information about diet and physical activity each week for 16 weeks. SELF-MONITORING: Participants record their food intake and weight directly into the Fitbit website or application 4-7 days each week or 1 day each week for 16 weeks. FAMILY TEAM INTERVENTION: Participants receive 2 group phone calls and join a Facebook group that is monitored by research staff where they can interact with each other and coaches.

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Determinants of adherence to recommendations on physical activity, red and processed meat intake, and body weight among lynch syndrome patients. [2023]

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

Beliefs about cancer and diet among those considering genetic testing for colon cancer. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Health and lifestyle behaviors among persons at risk of Lynch syndrome. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Health and lifestyle behaviors in colorectal cancer survivors with and without Lynch syndrome. [2023]

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

Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a cluster randomised trial protocol. [2020]