Overview

This trial is active, not recruiting.

Conditions colon cancer, rectal cancer
Treatments surveys
Sponsor Memorial Sloan Kettering Cancer Center
Start date October 2011
End date October 2017
Trial size 328 participants
Trial identifier NCT01458509, 11-101

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Telephone Group with Nurse Intervention
surveys
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.
Web Group with Nurse Intervention
surveys
Web: Study participants will be sent an email containing a link to the web survey. The participants will click on the link and complete the survey. Study participants may also login to the web survey independent of the link received via email. 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. 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.
Telephone Group without nurse intervention
surveys
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. This group will not get a phone call.
Web Group without nurse intervention
surveys
Web: Study participants will be sent an email containing a link to the web survey. The participants will click on the link and complete the survey. Study participants may also login to the web survey independent of the link received via email. 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. This group will not receive a phone call.

Primary Outcomes

Measure
clinically useful to collect patient-reported data
time frame: 6 months
feasibility of electronic PRO assessment
time frame: 2 years

Secondary Outcomes

Measure
psychometric equivalence
time frame: 2 years
problems people experience
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Comparison of the Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys
Principal investigator Larissa Temple, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.