Personalized Dietary Intervention in Managing Bowel Dysfunction and Improving Quality of Life in Stage I-III Rectosigmoid Cancer Survivors
NCT ID: NCT03063918
Last Updated: 2024-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2017-04-28
2021-09-07
Brief Summary
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Detailed Description
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I. Administer and determine the feasibility of the personalized dietary intervention.
II. Using qualitative methods, evaluate the acceptability of the intervention as reported by survivors.
III. Explore decisional conflict associated with treatment decision-making in rectal cancer surgery.
OUTLINE:
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.
After completion of study, patients are followed up for 6 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care (personalized dietary intervention)
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.
Informational Intervention
Receive a workbook
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive personalized dietary intervention
Interventions
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Informational Intervention
Receive a workbook
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive personalized dietary intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 6 months post-treatment completion
* Have a permanent ostomy or anastomosis
* English-speaking
* All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Hope Foundation
OTHER
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Virginia Sun, PhD, RN
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Countries
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Other Identifiers
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NCI-2017-00258
Identifier Type: REGISTRY
Identifier Source: secondary_id
16332
Identifier Type: OTHER
Identifier Source: secondary_id
16332
Identifier Type: -
Identifier Source: org_study_id
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