Colon Cancer, Rectal Cancer
Conditions
Keywords
Quality of Life, patient outcomes, questionaires, 11-101
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.
Interventions
BEHAVIORALsurveys
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.
BEHAVIORALSurveys
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinically useful to collect patient-reported data | 6 months | using electronic methods (interactive voice response system (IVRS) or web interface) |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed