Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys
A Comparison of the Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys
1 other identifier
observational
325
1 country
1
Brief Summary
It can be difficult to obtain the perspective of patients who have had bowel surgery. This study is being done because the investigators are trying to find out whether patient-reported outcomes, (results reported to investigators by the patient), on a regular basis, will help the investigators provide better patient care and symptom management. Therefore, the purpose of this study is to determine if it is possible and if it is useful to their medical care for patients who have had bowel surgery to complete surveys about their symptoms on a regular basis. In this study the surveys are completed from home, by web or by telephone, every month for 6 months. The results of this study will guide the design of large research studies on cancer-related bowel function. The purpose of this study is to develop a bowel function questionnaire for patients with colorectal cancer. The questionnaire will be used in future clinical trials to assess bowel function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2011
CompletedFirst Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
October 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2021
CompletedSeptember 10, 2021
September 1, 2021
9.9 years
October 18, 2011
September 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
clinically useful to collect patient-reported data
using electronic methods (interactive voice response system (IVRS) or web interface)
6 months
feasibility of electronic PRO assessment
we define feasibility as being the completion of 4/6 surveys. A complete survey is defined as having responses to 17/24 items (70%) on the survey. The administration mode will be deemed feasible if \>=70% of patients complete 4/6 surveys.
2 years
Secondary Outcomes (2)
psychometric equivalence
2 years
problems people experience
2 years
Study Arms (4)
IVRS ( interactive voice response system) EASP
Telephone Group with Nurse Intervention
Web EASP
Web Group with Nurse Intervention
IVRS ( interactive voice response system) No EASP
Telephone Group without nurse intervention
Web No EASP
Web Group without nurse intervention
Interventions
IVRS: An interactive voice response system (IVRS) is an automated telephone platform. The IVRS system will allow the participant to complete the survey when they receive the call and/or to call the system within the survey window to complete the survey. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. The intervention will be an email alert to study personnel (EASP). Patients randomized to EASP will receive a phone call if their bowel function by the clinical office nurse if the study personnel determine that the patient's BFI, as reported on the monthly survey, is less than 53 (lowest quartile scores). Interventions that may occur include dietary and/or medication advice at the discretion of the office staff.
Eligibility Criteria
Patients will be screened in colorectal surgery clinics on the 3rd floor of the MSKCC 53rd Street outpatient clinic buildings or at the Main Hospital at 1275 York Avenue or while they are an inpatients. Patients will be approached within 1-5 weeks post operatively to ensure that they can complete the first survey within the 4-6 week window.
You may qualify if:
- Aim 1:
- Stage I-III rectal cancer
- Post sphincter preserving surgery with restoration of bowel continuity within last 4-6 weeks at MSKCC.
- Access to web and email from home
- Web avidity (≥2 uses of email/week)
- Able to read and write in English
- Age ≥ 18
- Aim 2:
- Stage I-III colon and rectal cancer
- Post surgical resection of primary tumor at MSKCC
- Access to web and email from home
- Web avidity (≥2 uses of email/week)
- Able to read and write in English
- Age ≥ 18
You may not qualify if:
- Aim 1:
- Metastatic disease - Auditory, visual or motor impairment that would preclude ability to use telephone and/or computer.
- Stoma
- Participated in Aim 2
- Definitive SPS = Transanal Excision (TAE) or Transanal Endoscopic Microsurgery (TEM)
- Aim 2:
- Metastatic disease - Auditory, visual or motor impairment that would preclude ability to use telephone and/or computer.
- Stoma
- Participated in Aim 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julio Garcia-Aguilar, MD, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2011
First Posted
October 25, 2011
Study Start
October 11, 2011
Primary Completion
September 8, 2021
Study Completion
September 8, 2021
Last Updated
September 10, 2021
Record last verified: 2021-09