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

Completed

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.

Recruitment & 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:

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

Arm && Interventions

Group	Intervention	Description
Web EASP	Surveys	Web Group with Nurse Intervention
IVRS ( interactive voice response system) No EASP	Surveys	Telephone Group without nurse intervention
IVRS ( interactive voice response system) EASP	Surveys	Telephone Group with Nurse Intervention
Web No EASP	Surveys	Web Group without nurse intervention

Primary Outcome Measures

Name	Time	Method
feasibility of electronic PRO assessment	2 years	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.
clinically useful to collect patient-reported data	6 months	using electronic methods (interactive voice response system (IVRS) or web interface)

Secondary Outcome Measures

Name	Time	Method
psychometric equivalence	2 years	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.
problems people experience	2 years	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.

Locations (1): Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States

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