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Personalized Diet for Rectosigmoid Cancer
N/A
Waitlist Available
Led By Virginia Sun, PhD, RN
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights
Study Summary
This trial looks at how well a personalized diet can help manage bowel issues and improve quality of life for people who have rectosigmoid cancer.
Who is the study for?
This trial is for English-speaking stage I-III rectosigmoid cancer survivors who are at least 6 months post-treatment. Participants must be able to sign consent and have either a permanent ostomy or anastomosis. Those with stage IV disease or unable to follow safety requirements can't join.Check my eligibility
What is being tested?
The study tests personalized dietary interventions aimed at managing bowel dysfunction and improving quality of life in rectosigmoid cancer survivors. It involves understanding bowel symptoms, identifying food triggers, adjusting diets, and coaching on healthy eating post-cancer treatment.See study design
What are the potential side effects?
Since this trial focuses on dietary changes rather than medication, side effects may include discomfort from adjusting diet habits but are not expected to involve typical drug-related adverse reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability assessed by semi-structured interview
Bowel function assessed by Memorial Sloan Kettering Cancer Center Bowel Function Tool
Feasibility assessed by patient enrollment
+1 moreOther outcome measures
Scores from the Decisional Conflict Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (personalized dietary intervention)Experimental Treatment5 Interventions
At 6 months after standard of care treatment, patients receive 10 sessions of personalized dietary intervention over 30 minutes each over 4 months via the telephone. Patients also receive a workbook including reference materials and intervention content.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telephone-Based Intervention
2017
Completed Phase 2
~3400
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,657 Total Patients Enrolled
70 Trials studying Cancer Survivors
17,541 Patients Enrolled for Cancer Survivors
Hope FoundationOTHER
3 Previous Clinical Trials
314 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,450 Total Patients Enrolled
15 Trials studying Cancer Survivors
3,891 Patients Enrolled for Cancer Survivors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a permanent surgical opening in your body called an ostomy or a permanent connection between two organs called an anastomosis.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (personalized dietary intervention)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still able to sign up for the experiment?
"The clinical trial's details posted on the official website suggest that it is no longer looking for participants. Initially published in April 2017 and last revised in February 2022, this particular research project has stopped recruiting patients; however, there are 158 other trials taking applications at the moment."
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