Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-22 @ 7:42 AM
Study NCT ID:
NCT02107105
Status:
SUSPENDED
Last Update Posted:
2025-10-31
First Post:
2014-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Quality of Life and Utilities Following Surgical Treatment of Stage I-IV Rectal Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer
Status:
SUSPENDED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI requested
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2020-07835 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 2013-0631 | OTHER | M D Anderson Cancer Center | View | |
| K07CA133187 | NIH | None | https://reporter.nih.gov/quic… | View |