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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Adenocarcinoma, 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

Intervention / Treatment
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* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire)<br>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<br>* Complete quality of life questionnaire<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Complete quality of life questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health state utilities | A health state utility is the degree of preference that individuals or society has for a particular health state or condition. | At 24 months post-surgery |