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

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Colon Cancer
Rectal Cancer

Treatments

Behavioral: surveys
Behavioral: Surveys

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

325 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

325 participants in 4 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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