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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04733794
Other study ID # 15-8016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 19, 2016
Est. completion date December 18, 2018

Study information

Verified date February 2021
Source Fox Chase Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

Subjects will be recruited from patients presenting to the surgical oncology clinic at Fox Chase Cancer Center. These patients will have already undergone Low Anterior Resection with a diverting stoma (colostomy or ileostomy) and will be planning on undergoing reversal of their stoma in the near future. Subjects will be recruited over a period of 1 year. Such clinic patients' medical records will be reviewed to determine whether they are possible candidates for inclusion in the study. They will be identified based on their diagnosis of either Stage II or III rectal cancer as stated in prior clinic notes, pathology reports, or radiologic image reports. Participants must have previously undergone Low Anterior Resection with a diverting stoma and the surgical plan must be for them to undergo ostomy reversal. They will be approached during a clinic visit by either a co-investigator or a member of the surgery team (fellow or surgeon) or a research coordinator delegate and asked to participate in the research study. They will be given a document for informed consent that will describe the study and potential risks and benefits to the patient. The investigators plan to enroll 10 patients at Fox Chase Cancer Center. Subjects will receive no monetary compensation


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Stoma reversal
Patients will receive a comprehensive intervention to addresses bowel, sexual, and urinary dysfunction. Patients meeting appropriate inclusion criteria will be approached at a clinic visit with their surgeon. If they agree to participate, they will complete an initial baseline questionnaire. Questionnaires will be distributed on iPads during their clinic visit

Locations

Country Name City State
United States Fox Chase Cancer Center Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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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