Rectal Cancer Clinical Trial
Official title:
Feasibility of Implementing a Comprehensive, Patient-Centered Approach to Bowel Dysfunction After Low Anterior Resection for Rectal Cancer
Verified date | February 2021 |
Source | Fox Chase Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will facilitate a better understanding of the overall experience of our rectal cancer survivors after Low Anterior Resection for rectal cancer. Studies have demonstrated that the development of bowel and genitourinary dysfunction after this procedure is very distressing to patients and can have a significant impact on overall quality of life. By providing interventions that can be performed at home, investigator may alleviate these symptoms in hopes of improving the experience of patients undergoing Low Anterior Resection. By acknowledging these potentially debilitating symptoms in a systematic way, the investigator hopes to reinforce the importance of symptom management in the survivorship phase after treatment has been completed and ultimately facilitate an individual's return to routine activities.
Status | Completed |
Enrollment | 14 |
Est. completion date | December 18, 2018 |
Est. primary completion date | September 6, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Diagnosis of Stage II or III rectal cancer, a history of having an LAR with diverting stoma, and a plan to undergo stoma reversal within the next 6 months Exclusion Criteria: - Patients enrolled who develop an anastomotic leak at the time of stoma reversal that would necessitate another temporary or permanent stoma, they will be considered unevaluable and will be excluded from the analysis |
Country | Name | City | State |
---|---|---|---|
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Fox Chase Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bowel dysfunction | Symptoms will be assessed at scheduled visits with patient's provider by means of the follow up questionnaire containing 11 questions scored on a scale from 0 to 4 with a minimum score of 1 and a maximum score of 44 | 12 months | |
Primary | Urinary function | Symptoms will be assessed at scheduled visits with patient's provider by means of the follow up questionnaire containing 11 questions scored on a scale from 0 to 4 with a minimum score of 1 and a maximum score of 44 | 12 months | |
Primary | Sexual function | Symptoms will be assessed at scheduled visits with patient's provider by means of the follow up questionnaire containing 8-10 questions (8 for women and 10 for men) scored on a scale from 0 to 4 with a minimum score of 0 and maximum score of 40 | 12 months |
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