Clinical trial NCT01458509: Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys
Official title: A Comparison of the Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Rectal Cancer
Keywords: Quality of Life
patient outcomes
questionaires
11-101
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: clinically useful to collect patient-reported data
timeFrame: 6 months
measure: feasibility of electronic PRO assessment
timeFrame: 2 years
Secondary outcomes:
measure: psychometric equivalence
timeFrame: 2 years
measure: problems people experience
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Julio Garcia-Aguilar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: