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The researchers are doing this study to find out whether a high-fiber plant-based diet (HFPBD) can improve quality of life for people with CH. A HFPBD includes foods that are mainly from plants (for example, fruits,vegetables, nuts, beans, and whole grains). The researchers will measure quality of life by having participants complete questionnaires/surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Fiber Plant-Based Diet | Experimental | Participants will have a phone call or video call with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52. Participants will receive high-fiber plant-based meals for 12 weeks |
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| Usual care arm | Active Comparator | Participants will have phone calls with a member of the study team every 4 weeks for the first 12 weeks. After the first 12 weeks, participants will have a phone call or video call with a dietitian at Weeks 13 and 53 (end of study). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high-fiber plant-based meals | Other | A meal service will ship 12 frozen prepared meals per week to your home. |
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| Measure | Description | Time Frame |
|---|---|---|
| compare the rates of improvement in Quality Of Life | using the Quality of Life Global Health Status at W13D1 Scoring will be based on standard EORTC criteria | up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Urvi Shah, MD | Contact | 646-608-3713 | ShahNutrivention@mskcc.org | |
| Tamanna Haque, MD | Contact | 646-608-4166 |
| Name | Affiliation | Role |
|---|---|---|
| Urvi Shah, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (All Protocol Activities) | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D000074421 | Fermented Foods |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D003625 | Data Collection |
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| fermented foods | Other | Fermented foods will be encouraged on the diet. Fermented foods contain probiotics that help support a balanced gut microbiome and might improve overall digestion. |
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| supplements | Dietary Supplement | Patients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly) |
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| surveys | Other | QOL will be measured with the EORTC QLQ C30 |
|
| Memorial Sloan Kettering Monmouth (All Protocol Activities) | Recruiting | Middletown | New Jersey | 07748 | United States |
|
| Memorial Sloan Kettering Bergen (All Protocol Activities) | Recruiting | Montvale | New Jersey | 07645 | United States |
|
| Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) | Recruiting | Commack | New York | 11725 | United States |
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| Memorial Sloan Kettering Westchester (All Protocol Activities) | Recruiting | Harrison | New York | 10604 | United States |
|
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | Recruiting | New York | New York | 10065 | United States |
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| Memorial Sloan Kettering Nassau (All Protocol Activities) | Recruiting | Uniondale | New York | 11553 | United States |
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| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |