Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01458509
First received: October 18, 2011
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Colon Cancer
Rectal Cancer
Behavioral: surveys
Behavioral: Surveys

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of the Feasibility and Psychometric Properties of Paper vs. Web vs. Automated Telephone Administration of Patient Reported Outcome Surveys

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • clinically useful to collect patient-reported data [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    using electronic methods (interactive voice response system (IVRS) or web interface)

  • feasibility of electronic PRO assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • psychometric equivalence [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 328
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
IVRS ( interactive voice response system) EASP
Telephone Group with Nurse 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.
Web EASP
Web Group with Nurse Intervention
Behavioral: 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.
IVRS ( interactive voice response system) No EASP
Telephone Group without nurse 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. This group will not get a phone call.
Web No EASP
Web Group without nurse intervention
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458509

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Larissa Temple, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01458509     History of Changes
Other Study ID Numbers: 11-101
Study First Received: October 18, 2011
Last Updated: September 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of Life
patient outcomes
questionaires
11-101

ClinicalTrials.gov processed this record on November 25, 2014