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 |
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Recruitment Status :
Active, not recruiting
First Posted : October 14, 2019
Last Update Posted : October 10, 2023
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hereditary Breast Carcinoma Hereditary Ovarian Carcinoma Lynch Syndrome | 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 | Not Applicable |
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 : | 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 : | April 30, 2024 |
| Estimated Study Completion Date : | April 30, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Behavioral Dietary Intervention
Record food intake Other: E-mail Receive e-mails
Other Names:
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 |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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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).
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
| United States, Texas | |
| M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Karen M Basen-Engquist | M.D. Anderson Cancer Center |
| 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: | October 10, 2023 |
| Last Verified: | October 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carcinoma Breast Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Syndrome 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 Neoplastic Syndromes, Hereditary Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |