Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys

Rectal Cancer Clinical Trial

Official title:

A Comparison of the Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458509
• Other study ID #: 11-101
• Status: Completed
• Start date: October 11, 2011
• Est. completion date: September 8, 2021

Study information

• Verified date: September 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: September 8, 2021
• Est. primary completion date: September 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Rectal Cancer
• Rectal Neoplasms

Intervention

Behavioral:
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinically useful to collect patient-reported data	using electronic methods (interactive voice response system (IVRS) or web interface)	6 months
Primary	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	psychometric equivalence	Relevant in colorectal cancer trials via three different modes of administration: Web, IVRS, paper. The primary interest is the psychometric properties of the total score and subscale scores of the BFI, however individual items scores will be examined as well.	2 years
Secondary	problems people experience	With bowel function, bladder function, and sexual function over the course of treatment for rectal cancer and to identify the types of information that would be helpful to future patients. Patients who were enrolled in Aim 1 will be asked to participate in a 30-45 minute telephone interview. A total of 20 interviews will be conducted.	2 years

External Links

•   Memorial Sloan-Kettering Cancer Center