Evaluating quality of life after surgery for rectal cancer
Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer
This study looks at how surgery for rectal cancer affects the quality of life for patients over time, comparing those who received radiation therapy to those who didn’t.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 430 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT02107105 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the quality of life and health state utilities in patients who have undergone surgical treatment for stage I-IV rectal cancer. Patients will complete quality of life questionnaires at various intervals, including baseline, 6 months, 12 months, and annually up to 5 years post-surgery. The study aims to compare the effects of treatment with or without (neo)adjuvant radiation therapy and to track changes in quality of life over time.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed adenocarcinoma of the rectum at stages I-IV who are undergoing or have undergone surgical resection.
Not a fit: Patients with concurrent cancer diagnoses, recurrent disease, or those treated with pelvic radiation for other cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term quality of life for rectal cancer patients post-surgery.
How similar studies have performed: Other studies have successfully evaluated quality of life in cancer patients, suggesting that this approach is both relevant and valuable.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: George J Chang — M.D. Anderson Cancer Center
- Study coordinator: George Chang
- Email: GChang@mdanderson.org
- Phone: 713-792-6940
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.