An interventional study of Multimodal prehabilitation management Multimodal prehabilitation management in Colorectal Cancer, sponsored by Xiamen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Xiamen University · Not applicable, Interventional, and Treatment
The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. This is a prospective randomized controlled trail, designed to explore if the patients who take Colorectal Cancer Surgery will benefit from short-term multimodal prehabilitation strategy. multimodal prehabilitation includes exercise, nutrition supplement and physiology management preoperatively. It starts from the day that patients decide to take the surgery until the day before surgery, lasting 1\~2 week in The First Affiliated Hospital of Xiamen University. And investigators follow-up patients until 4 weeks after surgery to investigate if multimodal prehabilitation strategy can improve the postoperative functional recovery and improve the quality of life #reduce complications and improve prognosis.
The process of enhancing an individual's functional capacity to optimize physiologic reserves before an operation to withstand the stress of surgery has been coined prehabilitation. It has been confirm that trimodal prehabilitation strategy including exercise, diet and psychology guidance could improve postoperative functional recovery after surgery for patients undergoing colorectal resection. Although many clinical studies have confirmed that preoperative exercise for patients undergoing colorectal cancer surgery is safe and useful, but the prehabilitation strategy in previous studies usually takes 4\~8 weeks. However, patient suspected of malignant tumor often wouldn't wait for such a long period. Investigators therefore designed this study to investigate if a 1\~2 week multimodal prehabilitation strategy benefits the patients undergoing laparoscopic colorectal cancer resection. There will be 100 patients awaiting operation for primary colorectal cancer recruited in this research at The First Affiliated Hospital of Xiamen University.
After informed consent was obtained, the patients will be divided into two groups randomly, the prehibilitation group and control group.
The prehabilitation group will receive an individual trimodal prehabilitation strategy after a complete assessment, including physical exercise, nutritional optimization, and psychological therapy, as well as conventional guidance. The length of prehabilitation was determined by the waiting time till surgery alone. The control group will receive the conventional guidance, including drug treatment recommendations for chronic disease, quit smoking and abstinence. Both of the groups are also provided some useful information about surgery process. The functional capability will be examined for both groups at several time points (baseline, the day before surgery,4 weeks postoperatively) The primary end point is functional walking capacity as measured by the 6 minutes walking distance (6MWD) 4 weeks postoperatively, health-related quality of life scales and cancer-related fatigue. The secondary end points include self-reported physical activity, and prognosis information (postoperative complications, length of hospital stay, ICU stay time, hospitalization expenses, etc.).
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 100 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Xiamen University is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Multimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training ), nutritional suggestion and optimization#whey protein supplement#, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence).
Behavioral: Multimodal prehabilitation management Multimodal prehabilitation management
The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including drug treatment recommendations for chronic disease, quit smoking and abstinence.
Multimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise ), nutritional suggestion and optimization（whey protein supplement）, and psychological therapy, as well as conventional guidance (including drug treatment recommendations for chronic disease, quit smoking and abstinence).
6-minute-walking-distance (6MWD)
Use 6-minute-walking-distance (6MWD) to evaluate the physical functional capability objectively.
Time frame: [Time Frame: 4 weeks postoperatively]
Cancer-related fatigue
Use the Cancer Fatigue Scale to measure the fatigue of cancer patients in the last few weeks,The scale has 3 dimensions, include somatic fatigue, emotional fatigue and cognitive fatigue, with 15 entries. The scale is scored on a 5-point scale. Entries 1, 2, 3, 6, 9, 12, and 15 are used to assess somatic fatigue, 5, 8, 11, and 14 are used to assess emotional fatigue, and 4, 7, 10, and 13 are used to assess cognitive fatigue. The scale has a total score of 0-60, with somatic fatigue scoring in the range of 0-28, emotional fatigue and cognitive fatigue both scoring in the range of 0-16, and the higher the score, the more severe the fatigue.
Time frame: [Time Frame: 4 weeks postoperatively]
Quality of Life Scale
Use the SF-36 to evaluate the intermediate phase of recovery.The full scale consists of 25 items, including four dimensions and eight individual items, which are disease information (4 items), medical examination information (3 items), treatment information (6 items), and other service information (6 items). The scale was based on the Likert 4 scale, with answers of "not at all", "somewhat", "quite", and "very "The scores of each dimension/item were linearly converted to a scale of 0-100 according to the EORTC manual, and then the mean value was taken to obtain the total scale score.
Time frame: [Time Frame: 4 weeks postoperatively]
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Dec 2023, 8 months after the start.
Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 8 months is below that.
Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.
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