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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02107105
Enrollment
430
Registered
2014-04-08
Start date
2014-05-16
Completion date
2030-05-31
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

OTHERQuality-of-Life Assessment

Complete quality of life questionnaire

OTHERQuestionnaire Administration

Complete quality of life questionnaire

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Health state utilitiesAt 24 months post-surgeryA health state utility is the degree of preference that individuals or society has for a particular health state or condition.

Countries

United States

Contacts

CONTACTGeorge Chang
GChang@mdanderson.org713-792-6940
PRINCIPAL_INVESTIGATORGeorge J Chang

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026