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

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ClinicalTrials.gov Identifier: NCT04125914
Recruitment Status : Recruiting
First Posted : October 14, 2019
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Hereditary Breast Carcinoma Hereditary Ovarian Carcinoma Lynch Syndrome Mutation Carrier Behavioral: Behavioral Dietary Intervention Other: E-mail Behavioral: Exercise Intervention Other: Internet-Based Intervention Other: Questionnaire Administration Behavioral: Telephone-Based Intervention Other: Text Message Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: HEALTH4Families: Optimizing a Weight Management and Health Behavior Intervention for BRCA+ and Lynch Syndrome Families
Actual Study Start Date : January 26, 2017
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
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.
Behavioral: Behavioral Dietary Intervention
Record food intake

Other: E-mail
Receive e-mails
Other Names:
  • Electronic Mail
  • Email

Behavioral: Exercise Intervention
Undergo exercise

Other: Internet-Based Intervention
Join Facebook page

Other: Questionnaire Administration
Ancillary studies

Behavioral: Telephone-Based Intervention
Receive telephone coaching

Other: Text Message
Receive text messages
Other Names:
  • SMS Text
  • SMS Text Message
  • Text




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Physical activity- Physical Activity Readiness Questionnaire [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • At least 18 years old
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125914


Contacts
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Contact: Karen M Basen-Engquist 713-745-3123 kbasenen@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Karen M. Basen-Engquist    713-745-3123      
Principal Investigator: Karen M. Basen-Engquist         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Karen M Basen-Engquist M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04125914    
Other Study ID Numbers: 2016-0775
NCI-2019-02453 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0775 ( Other Identifier: M D Anderson Cancer Center )
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: July 23, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Neoplastic Syndromes, Hereditary
Carcinoma
Breast Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Disease
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases