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

Disqualifiers: Invasive cancer, Major surgery, others

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

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if weight management and healthy lifestyle changes can help individuals with genetic risks for cancer, such as hereditary breast and ovarian cancer or Lynch syndrome, lose weight and reduce their cancer risk. Participants will receive support through phone calls, emails, texts, and online groups to enhance their diet, exercise, and self-monitoring habits over 16 weeks. This health promotion and education program suits those with a genetic risk for these cancers who are not meeting recommended activity or dietary guidelines and are open to lifestyle changes. Participants should have internet access, a smartphone, and the ability to engage in regular physical activity. As an unphased trial, this study provides a unique opportunity for individuals to contribute to understanding lifestyle impacts on genetic cancer risks.

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 interventions are safe for participants?

Research has shown that lifestyle changes, such as increased physical activity and healthier eating, are generally safe and manageable. Similar studies have tested these programs, including a year-long online weight loss program, to ensure practicality and safety. Most participants report few, if any, side effects from activities like exercising or changing their diet.

A study focusing on individuals at high risk for hereditary cancers, such as BRCA and Lynch syndrome, confirmed the safety of these lifestyle changes. Participants in these studies often experienced positive outcomes, such as a reduced risk of cancer and improved overall health, without major side effects.

In summary, changing diet and exercise habits is not only safe but can also help prevent and manage cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it emphasizes a holistic approach to reducing cancer risk in BRCA and Lynch syndrome families through lifestyle changes. Unlike standard preventive measures that often focus solely on regular screenings and genetic counseling, this intervention integrates personalized support via telephone and email coaching, along with self-monitoring tools like Fitbit. Additionally, the family team component encourages group interactions, fostering a supportive environment that can enhance motivation and adherence to healthier behaviors. This comprehensive strategy aims to empower participants with sustainable habits that could significantly lower their cancer risk.

What evidence suggests that this trial's interventions could be effective for cancer risk reduction in BRCA/Lynch syndrome families?

Research has shown that lifestyle changes, such as improving diet and increasing exercise, can significantly reduce cancer risk, even for those with genetic predispositions like BRCA or Lynch syndrome. This trial evaluates a health behavior intervention that includes personalized coaching and electronic communication, such as text messages, to support these lifestyle changes. Participants will receive a combination of interventions, including text messages and online support, which have successfully encouraged healthy habits in other health areas. These tools help individuals stay motivated and committed to their health goals. Overall, these methods have shown promise in helping individuals manage weight and improve lifestyle, both important for lowering cancer risk. ^{6 7 8 9 10}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3980005/

Text Messaging-Based Smoking Cessation Intervention Smoking cessation interventions delivered via text messaging on mobile phones may enhance motivations to quit smoking. The goal of this narrative review is to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9293135/

Effectiveness of an optimized text message and Internet ... To evaluate the effectiveness of a combined internet and text message intervention for smoking cessation compared with an internet intervention alone.

3. jmir.org jmir.org/2024/1/e58174/

Assessing the Effectiveness of eHealth Interventions to ... Moreover, SMS text messaging may be particularly powerful for smoking behaviors ... Lynch BM, et al. Effects of a telephone-delivered multiple ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-3528-5

The efficacy of mobile phone-based text message ... ... health related researchers and experts in cognitive behavioral therapy, and smoking cessation. ... Lynch K, Bromberg JE. Text to Quit China: An ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10510452/

Mobile Phone–Based Interventions for Smoking Cessation ... Combining data from 5 studies using a random-effects meta-analysis, a significant improvement in continuous abstinence rates was observed with SMS text ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11090968/

Interventions about physical activity and diet and their ... Similarly to these studies, Lynch et al. [46] tested the feasibility, efficacy, and safety of a 1-year long web-based weight loss intervention ...

7. mdpi.com mdpi.com/1660-4601/19/21/14098

Lifestyle Behavior Interventions for Preventing Cancer in ... One study included only healthy individuals with a high risk of BRCA or Lynch [38], one only BRCA carriers with a personal history of cancer [37], and the other ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02516540

NCT02516540 | Efficacy of Lifestyle Intervention in BRCA1 ... Structured exercise training plus mediterranean diet: Study participants receive a lifestyle intervention of 12 months duration (3 months intensive intervention ...

9. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.797794/full

Association of Healthy Diet and Physical Activity With ... The recent findings reveal that even minimal amounts of daily exercise and a healthy diet reduced the risk of BC, mitigated the side effects of cancer ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2047289/

Internet-Based Physical Activity Interventions: A Systematic ... Objective. The aim of the study was to systematically assess the methodological quality and the effectiveness of interventions designed to promote physical ...