An interventional study of Behavioral Dietary Intervention and E-mail in Hereditary Breast Carcinoma, Hereditary Ovarian Carcinoma and Lynch Syndrome, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Prevention
Among 11 studies in Colorectal Neoplasms, Hereditary Nonpolyposis by M.D. Anderson Cancer Center — 1 open to participants now, 4 under way, none of them phase 3. Colorectal Neoplasms, Hereditary Nonpolyposis · M.D. Anderson Cancer Center.
Among the 11 studies in Colorectal Neoplasms, Hereditary Nonpolyposis by M.D. Anderson Cancer Center, this one is the only one that started in 2017, is one of 4 with no phase, and was the 9th registered.
145 studies on the registry are indexed under Colorectal Neoplasms, Hereditary Nonpolyposis; 59 are open to participants now.
Browse Colorectal Neoplasms, Hereditary Nonpolyposis studies →1 of the 11 studies in Colorectal Neoplasms, Hereditary Nonpolyposis by M.D. Anderson Cancer Center is open now, in 1 country. Recruiting first, the newest first:
M.D. Anderson Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 43 Colorectal Neoplasms, Hereditary Nonpolyposis studies recruiting now, 32 (74%) set no upper age limit and 4 (9%) stop at 75 or younger; 4 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 1994; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 384 is above the median of 200 across 75 interventional studies indexed under Colorectal Neoplasms, Hereditary Nonpolyposis.
Median enrollment 205 across the 5 interventional studies, 198 across the 6 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
2 of the studies in Colorectal Neoplasms, Hereditary Nonpolyposis by M.D. Anderson Cancer Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02194387M.D. Anderson Cancer CenterEnergy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members | 2027-09-30 |
| NCT05677048M.D. Anderson Cancer CenterFeasibility Study: IGNITE-TX (Identifying Individuals for Genetic Testing & Treatment) Intervention | 2027-10-31 |
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Among the 11 studies in Colorectal Neoplasms, Hereditary Nonpolyposis by M.D. Anderson Cancer Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have at least one of the following risk factors:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Other: E-mail · Behavioral: Exercise Intervention · Other: Health Promotion and Education · Other: Internet-Based Intervention · Other: Questionnaire Administration · Behavioral: Telephone-Based Intervention
Record food intake
Receive e-mails
Also known as: Electronic Mail, Email
Undergo exercise
Receive text messages
Join Facebook page
Ancillary studies
Receive telephone coaching
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.
Time frame: Baseline to 4 months
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.
Time frame: Up to 8 months
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.
Time frame: Up to 8 months
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.
Time frame: Up to 8 months
Started Jan 2017 (actual). Primary completion is estimated for Apr 2028, 135 months after the start.
Of 37 interventional studies with no phase under Colorectal Neoplasms, Hereditary Nonpolyposis, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 86. This study's planned 135 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 6, 2026: primary completion Apr 2026 → Apr 2028 and completion Apr 2026 → Apr 2028.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Colorectal Neoplasms, Hereditary Nonpolyposis →