Study of the effect of bridge symptom intervention in symptom management of colorectal cancer patients undergoing postoperative chemotherapy

ISRCTN	ISRCTN11016599
DOI	https://doi.org/10.1186/ISRCTN11016599
Major Project of Philosophy and Social Science Research in Colleges and Universities in Jiangsu Province Grant No	2023SJZD144
Sponsor	Government of Jiangsu Province
Funder	Government of Jiangsu Province

Submission date: 25/12/2025
Registration date: 09/01/2026
Last edited: 06/01/2026

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Ms LI Tian
Principal investigator, Public, Scientific

School of Nursing, Suzhou Medical College of Soochow University
Suzhou
215006
China

Phone	+86 13081655183
Email	20235231053@stu.suda.edu.cn

Study information

Primary study design	Interventional
Allocation	Non-randomized controlled trial
Masking	Open (masking not used)
Control	Placebo
Assignment	Parallel
Purpose	1. Develop a bridging symptom intervention program for patients undergoing adjuvant chemotherapy after colorectal cancer (CRC) surgery； 2. Evaluate the efficacy of bridging symptom intervention in symptom management for patients undergoing adjuvant chemotherapy after CRC surgery.
Scientific title	The study on the effect of bridge symptom intervention in symptom management of colorectal cancer patients undergoing postoperative chemotherapy
Study objectives
Ethics approval(s)	Approved 15/08/2025, Ethics Committee of Soochow University (Room 1312, Comprehensive Building, First Affiliated Hospital of Soochow University, No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province, 215006, China; +86 512 6797 2861; sdfyec@163.com), ref: SUDA20250108H13
Health condition(s) or problem(s) studied	Symptom management in patients undergoing adjuvant chemotherapy after colorectal cancer surgery
Intervention	Randomization Grouping Method: Block randomization method is adopted. The specific operation process is as follows: First, patients are sorted according to their enrollment time, and different block lengths (i.e., each block includes a different number of patients) are set to divide all patients into several blocks; subsequently, the simple randomization method is used to number the patients in each block sequentially (1, 2, 3...); starting from any position in the random number table, a corresponding number of random numbers are continuously selected and assigned to each patient in the block; then, the random numbers are ranked and numbered according to their values. It is pre-specified that patients whose random number ranking falls within a certain range in each block are included in Group A (control group), and those whose ranking falls within another range are included in Group B (intervention group). Interventional Measure 1. Vomiting: Knowledge Education + PMR Guidance and Practice + Problem-Solving. PMR guidance: 1. Clench fists - relax; stretch all five fingers - relax 2. Clench fists and bend arms upward - relax; straighten fingers and stretch arms forcefully - relax 3. Furrow the forehead tightly - relax; frown deeply - relax 4. Close eyes tightly - relax 5. Press the tongue firmly against the upper palate - relax 6. Close lips tightly - relax 7. Tilt the head back as far as possible in sequence - bend to the right - bend to the left - finally lower the head to press against the chest - relax 8. Shrug shoulders upward - relax; shrug shoulders forward - relax 9. Take a deep breath - relax 10. Push the abdomen out forcefully - relax; tighten the abdomen forcefully - relax 11. Bend the waist forward - relax 12. Lift the lower legs to tense the buttocks and thighs - lower the lower legs to relax 13. Press the heels down hard to tense the calf and thigh muscles - relax 14. Press the toes down hard to tense the calf muscles - relax 15. Curl the soles of the feet outward to both sides to tense the calves - relax 2. Fatigue: Pre-Exercise Assessment → Individualized Prescription (50-65% HRmax, 10-45 mins, ≥3 days/week). Pre-exercise Assessment: 1. Fatigue level: The Numerical Rating Scale (NRS) is used for screening and recording, where 0 points indicate no fatigue, 1-3 points indicate mild fatigue, 4-6 points indicate moderate fatigue, and 7-10 points indicate severe fatigue. For patients with no or mild (0-3 points) fatigue, continuous monitoring is conducted; for patients with moderate to severe (4-10 points) fatigue, exercise management is implemented 2. Presence of contraindications (such as extensive osteolytic bone metastasis, extreme thrombocytopenia, anemia, fever or active infection; restrictions secondary to cancer metastasis or other comorbidities; safety issues, such as high risk of falls assessed) 3. Develop a personalized exercise plan based on the patient's basic conditions such as age, gender, treatment status and physical condition Individualized Prescription: 1. Exercise form: Aerobic exercise. According to the patient’s daily exercise habits, guide the patient to choose exercise forms such as walking, going up and down stairs, jogging, Baduanjin, cycling, etc. Considering the age and safety of CRC patients undergoing adjuvant chemotherapy, strenuous exercise is not suitable, so walking, going up and down stairs and other exercise methods are recommended first 2. Exercise intensity: Start from low intensity to moderate intensity exercise (the exercise intensity is when the heart rate reaches 50%-65% of the maximum heart rate; the maximum heart rate for women = 210 - age, and the maximum heart rate for men = 220 - age) 3. Duration: Start from a low duration. Perform 5-10 minutes of stretching warm-up exercises before and after exercise, move the limbs to avoid limb injuries during exercise, and exercise for 10-45 minutes every day 4. Exercise frequency: At least 3 days a week
Intervention type	Behavioural
Primary outcome measure(s)	Symptom clusters score measured using the Chinese version of the Memorial Symptom Assessment Scale (MSAS-C) at the day before chemotherapy (T0), the end of the 2nd chemotherapy cycle (T1), the end of the 4th chemotherapy cycle (T2), the end of the 6th chemotherapy cycle (T3)
Key secondary outcome measure(s)
Completion date	25/06/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	106
Total final enrolment	106
Key inclusion criteria	1. Age ≥ 18 years old 2. Confirmed as CRC by pathological report and receiving adjuvant chemotherapy after surgery for the first time 3. Receiving the combined chemotherapy regimen XELOX (oxaliplatin and capecitabine) 4. Undergoing laparoscopic surgery as the surgical approach 5. Clinical Stage II and Stage III 6. Voluntary participation
Key exclusion criteria	1. Patients with severe physical diseases, such as other malignant tumors 2. Patients with organic brain diseases or complicated with other mental disorders 3. Patients with a previous history of ostomy surgery 4. Patients who need to have their condition concealed
Date of first enrolment	21/08/2025
Date of final enrolment	30/11/2025

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Jingjing Hou, 20235231053@stu.suda.edu.cn. Expected sharing date: August 1, 2026.

Editorial Notes

06/01/2026: Study’s existence confirmed by the Medical Ethics Committee of the First Affiliated Hospital of Soochow University, China.