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Recruiting NCT02107105

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

— Observational Rectal Adenocarcinoma Stage I Rectal Cancer AJCC v8 Stage II Rectal Cancer AJCC v8 Stage IIA Rectal Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Quality-of-Life Assessment, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Rectal Adenocarcinoma, Stage I Rectal Cancer AJCC v8, Stage II Rectal Cancer AJCC v8, Stage IIA Rectal Cancer AJCC v8. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer

Overview

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:

I. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years.

SECONDARY OBJECTIVES:

I. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy.

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

III. 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.

Interventions

  • Other Quality-of-Life Assessment
    Complete quality of life questionnaire
  • Other Questionnaire Administration
    Complete quality of life questionnaire

Primary outcome measures

  • Health state utilities [Time frame: At 24 months post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Identifiers

NCT: NCT02107105 · 2013-0631 · NCI-2020-07835 · 2013-0631 · K07CA133187

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗