NCT02107105Recruiting

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

M.D. Anderson Cancer Center

Start Date

5/16/2014

Completion Date

5/31/2030

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: 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. IV. To identify gaps in preoperative counseling for pelvic exenteration by eliciting in-depth insights into patient values, expectations, and lived experiences through qualitative interviews with patients who have undergone surgery for locally advanced or recurrent rectal cancer. V. To identify themes, communication strategies, and informational content used during preoperative counseling for pelvic exenteration through qualitative interviews with providers. 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

OTHER

Quality-of-Life Assessment

OTHER

Questionnaire Administration

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Conditions

Rectal AdenocarcinomaStage I Rectal Cancer AJCC v8Stage II Rectal Cancer AJCC v8Stage IIA Rectal Cancer AJCC v8Stage IIB Rectal Cancer AJCC v8Stage IIC Rectal Cancer AJCC v8Stage III Rectal Cancer AJCC v8Stage IIIA Rectal Cancer AJCC v8Stage IIIB Rectal Cancer AJCC v8Stage IIIC Rectal Cancer AJCC v8Stage IV Rectal Cancer AJCC v8Stage IVA Rectal Cancer AJCC v8Stage IVB Rectal Cancer AJCC v8Stage IVC Rectal Cancer AJCC v8

Locations

M D Anderson Cancer Center

Houston, Texas 77030

United States