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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04125914
Recruitment Status : Active, not recruiting
First Posted : October 14, 2019
Last Update Posted : October 10, 2023
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE October 14, 2019
Last Update Posted Date October 10, 2023
Actual Study Start Date  ICMJE January 26, 2017
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
Percent weight loss [ Time Frame: Baseline to 4 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
  • Fruit and vegetable consumption [ Time Frame: Up to 8 months ]
    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 [ Time Frame: Up to 8 months ]
    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 [ Time Frame: Up to 8 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight Management and Health Behavior Intervention in Lowering Cancer Risk for BRCA Positive and Lynch Syndrome Families
Official Title  ICMJE HEALTH4Families: Optimizing a Weight Management and Health Behavior Intervention for BRCA+ and Lynch Syndrome Families
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hereditary Breast Carcinoma
  • Hereditary Ovarian Carcinoma
  • Lynch Syndrome
Intervention  ICMJE
  • Behavioral: Behavioral Dietary Intervention
    Record food intake
  • Other: E-mail
    Receive e-mails
    Other Names:
    • Electronic Mail
    • Email
  • Behavioral: Exercise Intervention
    Undergo exercise
  • Other: Health Promotion and Education
    Receive text messages
  • Other: Internet-Based Intervention
    Join Facebook page
  • Other: Questionnaire Administration
    Ancillary studies
  • Behavioral: Telephone-Based Intervention
    Receive telephone coaching
Study Arms  ICMJE Experimental: Prevention (weight management, health behavior intervention)
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.
Interventions:
  • Behavioral: Behavioral Dietary Intervention
  • Other: E-mail
  • Behavioral: Exercise Intervention
  • Other: Health Promotion and Education
  • Other: Internet-Based Intervention
  • Other: Questionnaire Administration
  • Behavioral: Telephone-Based Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2019)
384
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2024
Estimated Primary Completion Date April 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04125914
Other Study ID Numbers  ICMJE 2016-0775
NCI-2019-02453 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0775 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party M.D. Anderson Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE M.D. Anderson Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Karen M Basen-Engquist M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP