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

M.D. Anderson Cancer Center

Status: Suspended

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

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

Study type: Observational

Funder types: Other

Identifiers

NCT02107105

NCI-2020-07835 (Registry Identifier)

K07CA133187 (U.S. NIH Grant/Contract)

2013-0631 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

430 participants in 1 patient group

Observational (questionnaire)

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment