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

Primary Purpose

Hereditary Breast Carcinoma, Hereditary Ovarian Carcinoma, Lynch Syndrome

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Dietary Intervention
E-mail
Exercise Intervention
Health Promotion and Education
Internet-Based Intervention
Questionnaire Administration
Telephone-Based Intervention
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hereditary Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (weight management, health behavior intervention)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 6, 2019
Last Updated
October 5, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04125914
Brief Title
Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families
Official Title
HEALTH4Families: Optimizing a Weight Management and Health Behavior Intervention for BRCA+ and Lynch Syndrome Families
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Breast Carcinoma, Hereditary Ovarian Carcinoma, Lynch Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prevention (weight management, health behavior intervention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Dietary Intervention
Intervention Description
Record food intake
Intervention Type
Other
Intervention Name(s)
E-mail
Other Intervention Name(s)
Electronic Mail, Email
Intervention Description
Receive e-mails
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo exercise
Intervention Type
Other
Intervention Name(s)
Health Promotion and Education
Intervention Description
Receive text messages
Intervention Type
Other
Intervention Name(s)
Internet-Based Intervention
Intervention Description
Join Facebook page
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Based Intervention
Intervention Description
Receive telephone coaching
Primary Outcome Measure Information:
Title
Percent weight loss
Description
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.
Time Frame
Baseline to 4 months
Secondary Outcome Measure Information:
Title
Fruit and vegetable consumption
Description
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.
Time Frame
Up to 8 months
Title
Percent energy from fat
Description
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.
Time Frame
Up to 8 months
Title
Physical activity
Description
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.
Time Frame
Up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Basen-Engquist
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

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

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