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NCT Number: NCT02107105

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

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

George J. Chang

CONTACT

713-792-6940

George J. Chang

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality-of-Life Assessment

Other

Complete quality of life questionnaire

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete quality of life questionnaire

Primary outcomes

  1. Health state utilities

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

George Chang

CONTACT

[email protected]

713-792-6940

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2030
Study completion
2030
First posted
Apr 8, 2014
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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