Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer

NCT02107105 | Suspended

• 3 other identifiers: 2013-0631NCI-2020-07835K07CA133187
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.

Conditions

Rectal Adenocarcinoma; Stage I Rectal Cancer AJCC v8; Stage II Rectal Cancer AJCC v8; Stage IIA Rectal Cancer AJCC v8; Stage IIB Rectal Cancer AJCC v8; Stage IIC Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Health state utilities

  A health state utility is the degree of preference that individuals or society has for a particular health state or condition.

  At 24 months post-surgery

Study Arms (1)

Observational (questionnaire)

Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Quality-of-Life Assessment OTHER

Complete quality of life questionnaire

Also known as: Quality of Life Assessment

Observational (questionnaire)

Questionnaire Administration OTHER

Complete quality of life questionnaire

Observational (questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with stave I-IV rectal adenocarcinoma at the Colorectal Clinic at M D Anderson Cancer Center

You may qualify if:

• Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment
• Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English

You may not qualify if:

• Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer
• Patient has a concurrent cancer diagnosis at the time of consent
• Patient has recurrent disease

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• George J Chang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 8, 2014
• Study Start: May 16, 2014
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)