Functional Outcomes and Quality of Life in Patients Undergoing Surgery for Rectal Cancer
Study Overview
Detailed Description
Rectal cancer is the second most common cancer in North America. Therapy has rapidly improved over the last 20 years, and the surgical technique of total mesorectal excision, as well as advances in radiation and chemotherapy, have resulted in improved survival and decreased local recurrence. As a result, survivorship issues become increasingly important for patients with rectal cancer.
Patients uniformly demonstrate a strong desire to avoid a permanent stoma and show strong preferences for sphincter preserving surgery (SPS). With the introduction of the circular stapler, SPS is technically possible in a higher proportion of patients. Additionally, even tumors at the anorectal ring are considered amenable to SPS in select patients with ultra-low rectal cancers.
At present, long-term outcomes after rectal cancer surgery are poorly understood. Bowel, bladder and sexual function appear to be negatively affected by multi-modality therapy. However, function has been poorly studied, and it is difficult to translate the data into clinically meaningful information for patients. Clinically, bowel, bladder and sexual dysfunction seem to affect quality of life (QOL), although this has never been well studied. It is important to quantify the extent of impairment so that it can be used to educate patients preoperatively. However, translating these data to clinicians and patients remains challenging, and efforts to convey the data in a meaningful manner preoperatively constitute an important element in managing patient expectations. By understanding patients' baseline needs, expectations and satisfaction at the time of the preoperative consent, we can begin to develop novel preoperative strategies for educating patients about postoperative function and quality of life in a meaningful manner, so that they may better adapt after surgery. We ultimately plan to use data from this study to develop and subsequently evaluate the role of an educational tool outlining functional outcomes after rectal cancer surgery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Stage I-III rectal adenocarcinoma based on preoperative testing
- Surgery (Sphincter preserving - transanal (TAE),transanal endoscopic microsurgery (TEM), low anterior resection (LAR), coloanal resection (CAA), OR Permanent stoma - abdominal perineal resection (APR)) planned at MSKCC
- Age > or = to 18
- Speak English
Exclusion Criteria:
- Stage IV disease at time of pre-operative consult
- History of other malignancies (besides squamous cell or basal cell cancer of skin) less than five years ago
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1
Patients Undergoing Surgery for Rectal Cancer
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Prior to surgery, patients will be asked to complete baseline surveys.
In addition, a random subsample of approximately 30 patients will be asked to participate in a short qualitative interview to explore expectations regarding bowel function and quality of life following surgery.
Follow-up surveys will be completed at 6, 12 and 24 months after bowel continuity has been restored (defined by their last surgical procedure).
Patients with a permanent stoma will receive the Stoma-specific QOL questions in place of the MSKCC Bowel Function Instrument at 6 and 12 months after initial surgery.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To prospectively evaluate bowel, sexual and bladder function in patients who undergo resection for stage I-III rectal cancer.
Time Frame: Two sets of surveys before surgery. After surgery, the participant will be asked to fill out some or all of a series of surveys at 6, 12, and 24 months.
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Two sets of surveys before surgery. After surgery, the participant will be asked to fill out some or all of a series of surveys at 6, 12, and 24 months.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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To assess the impact of bowel, bladder and sexual function on quality of life over time in patients undergoing resection for stage I-III rectal cancer and to compare QOL in patients with and without a stoma.
Time Frame: Two sets of surveys before surgery. After surgery, the participant will be asked to fill out some or all of a series of surveys at 6, 12, and 24 months.
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Two sets of surveys before surgery. After surgery, the participant will be asked to fill out some or all of a series of surveys at 6, 12, and 24 months.
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To evaluate the expectations, informational needs and satisfaction with the surgical consent process in patients undergoing resection for stage I-III rectal cancer.
Time Frame: Two sets of surveys before surgery. After surgery, the participant will be asked to fill out some or all of a series of surveys at 6, 12, and 24 months.
|
Two sets of surveys before surgery. After surgery, the participant will be asked to fill out some or all of a series of surveys at 6, 12, and 24 months.
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Collaborators and Investigators
Investigators
- Principal Investigator: Julio Garcia-Aguilar, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-151
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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