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

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02107105
Collaborator
(none)
300
1
132.5
2.3

Study Details

Study Description

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.

Detailed Description

PRIMARY OBJECTIVE:
  1. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.
SECONDARY OBJECTIVES:
  1. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.

  2. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer.

  3. To assess changes in quality of life and utilities among patients treated for rectal cancer over time.

OUTLINE:

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer
Actual Study Start Date :
May 16, 2014
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
May 31, 2025

Arms and Interventions

Arm Intervention/Treatment
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
Complete quality of life questionnaire
Other Names:
  • Quality of Life Assessment
  • Other: Questionnaire Administration
    Complete quality of life questionnaire

    Outcome Measures

    Primary Outcome Measures

    1. Health state utilities [At 24 months post-surgery]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    Exclusion Criteria:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: George J Chang, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT02107105
    Other Study ID Numbers:
    • 2013-0631
    • NCI-2020-07835
    • 2013-0631
    • K07CA133187
    First Posted:
    Apr 8, 2014
    Last Update Posted:
    Apr 1, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2021