Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families

Lynch Syndrome Clinical Trial

Official title:

HEALTH4Families: Optimizing a Weight Management and Health Behavior Intervention for BRCA+ and Lynch Syndrome Families

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04125914
• Other study ID #: 2016-0775
• Secondary ID: NCI-2019-0245320
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2017
• Est. completion date: April 30, 2026

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

PRIMARY OBJECTIVES:

I. Identify the most effective intervention components for weight loss (primary outcome) and percent energy from fat, vegetable and fruit consumption, physical activity, and theory based behavioral determinants (secondary outcomes), with the goal of developing an optimized weight management intervention for hereditary breast and ovarian cancer (HBOC) and Lynch syndrome (LS) mutation carriers and their family members.

II. Identify the most effective intervention combination that could be delivered for a cost of $364 or less, which is the reimbursement level provided by Medicare for 6 months of intensive behavioral weight loss counseling.

III. Explore the effects of each component on weight loss, vegetable and fruit consumption, percent energy from fat, and physical activity 4 months after the end of the intervention.

IV. Evaluate whether the effects of the intervention components differ by mutation status, previous cancer diagnosis in the index participant, HBOC versus (vs) LS, family environment, and gender of index participant.

V. Pilot test the intervention in MD Anderson's Cancer Prevention Center, to determine the feasibility of providing the intervention components in a clinical setting.

OUTLINE:

Participants are randomized to 1 of 24 conditions, each comprising weight management and health behavior intervention with different combinations of 4 components for 16 weeks. The 4 components are: telephone coaching vs email coaching vs no coaching, text messages vs no text messages, self-monitoring 4-7 days a week vs 1 day per week, and a family team intervention vs none.

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 (patients and their family members) 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. The Facebook group includes weekly updates on team progress, weekly family challenges and live online chats with a dietitian and exercise expert.

After completion of study, patients are followed up at 4 and 8 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 384
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HEALTH4Families only: Positive for either HBOC or LS predisposing mutations OR a family member of a mutation carrier (family members do not need to be biological relatives).

• HEALTH4Families only: Index participant ONLY: Must have at least one family member who is eligible and consents to participation.

• Have at least one of the following risk factors:

• Body mass index (BMI) of 25 or higher

• < 5 servings of vegetables and fruits per day

• < 150 minutes per week of moderate intensity activity

• 75 minutes per week of vigorous intensity activity

• Able to read and write English.

• Have a cellular telephone and are able and willing to send and receive text messages.

• Access to internet via desktop or mobile device.

• Capable of participating in moderate-vigorous unsupervised exercise.

• HEALTH4CPC only: Patient in MD Anderson's Cancer Prevention Center coming in to the clinic for one of the following appointment types: consult and new patient screening appointments

• HEALTH4CPC only: Female.

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

• HEALTH4CPC only: Has a smartphone.

Exclusion Criteria:

• Unable to walk without crutches, walker, cane, or other assistive device.

• Women who are pregnant or nursing (by self-report).

• Currently receiving radiation therapy or cytotoxic chemotherapy.

• Within 3 months of major surgery.

• Does not live in the United States.

• HEALTH4CPC only: Persons diagnosed with any invasive cancer excluding non-melanoma skin cancer.

• HEALTH4CPC only: Patient at high risk for cancer.

• HEALTH4CPC only: Participated in the HEALTH 4 MD Anderson pilot study (protocol 2014-0230).

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Breast Carcinoma
• Hereditary Ovarian Carcinoma
• Lynch Syndrome
• Syndrome

Intervention

Behavioral:
• Behavioral Dietary Intervention
Record food intake

Other:
• E-mail
Receive e-mails

Behavioral:
• Exercise Intervention
Undergo exercise

Other:
• Health Promotion and Education
Receive text messages
• Internet-Based Intervention
Join Facebook page
• Questionnaire Administration
Ancillary studies

Behavioral:
• Telephone-Based Intervention
Receive telephone coaching

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent weight loss	The data from the proposed factorial experiment will be analyzed through analysis of variance (ANOVA) with repeated measures. The outcome variable is the percent weight loss of each participant at 4 months. The fixed covariates include indicator variables for all intervention components. The model includes a random intercept that introduces within-family correlation. The main effect of each intervention component will be tested in an F-test at alpha = 0.0125 level. The pairwise interactions of the intervention components will be studied in an exploratory fashion. The optimal intervention is defined to be the combination of the four components that produces the best percent weight loss result within the resource constraints. Data can also be analyzed jointly in a linear mixed model that includes intervention components and time as fixed effect, family as random intercept and longitudinal correlation between 4 and 8 month data.	Baseline to 4 months
Secondary	Fruit and vegetable consumption	The data from the proposed factorial experiment will be analyzed through ANOVA with repeated measures. The fixed covariates include indicator variables for all intervention components. The model includes a random intercept that introduces within-family correlation. The main effect of each intervention component will be tested in an F-test at alpha = 0.0125 level. Similar ANOVA analysis will be conducted for the 8 month outcome to study whether the intervention effect persists 4 months after the end of the intervention. The 4- and 8-month data can also be analyzed jointly in a linear mixed model that includes intervention components and time as fixed effect, family as random intercept and longitudinal correlation between 4 and 8 month data.	Up to 8 months
Secondary	Percent energy from fat	The data from the proposed factorial experiment will be analyzed through ANOVA with repeated measures. The fixed covariates include indicator variables for all intervention components. The model includes a random intercept that introduces within-family correlation. The main effect of each intervention component will be tested in an F-test at alpha = 0.0125 level. Similar ANOVA analysis will be conducted for the 8 month outcome to study whether the intervention effect persists 4 months after the end of the intervention. The 4- and 8-month data can also be analyzed jointly in a linear mixed model that includes intervention components and time as fixed effect, family as random intercept and longitudinal correlation between 4 and 8 month data.	Up to 8 months
Secondary	Physical activity	The data from the proposed factorial experiment will be analyzed through ANOVA with repeated measures. The fixed covariates include indicator variables for all intervention components. The model includes a random intercept that introduces within-family correlation. The main effect of each intervention component will be tested in an F-test at alpha = 0.0125 level. Similar ANOVA analysis will be conducted for the 8 month outcome to study whether the intervention effect persists 4 months after the end of the intervention. The 4- and 8-month data can also be analyzed jointly in a linear mixed model that includes intervention components and time as fixed effect, family as random intercept and longitudinal correlation between 4 and 8 month data.	Up to 8 months

External Links

•   MD Anderson Cancer Center Website