An observational study in Rectal Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by Memorial Sloan Kettering Cancer Center · Observational
The purpose of this study is to find out what happens to patients after they have surgery for rectal cancer. After being treated for rectal cancer, patients tell us that their bowel, bladder and sexual function have changed. We are trying to understand how these changes affect your quality of life. The research that we have now does not explain these changes or problems very well. The patients will be asked questions about bowel function, bladder function, sexual function, and quality of life so we can understand these changes better. This will help us take better care of our patients in the future, before and after their treatment for rectal cancer.
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 229 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
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Participants are being asked to take part in this study because they have rectal cancer and are planning on having surgery done at MSKCC.
Exclusion Criteria:
Patients Undergoing Surgery for Rectal Cancer
Behavioral: Questionaires
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.
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.
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.
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.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center