Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors

Sponsor

Qu Shen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05956990

Collaborator

The First Affiliated Hospital of Xiamen University (Other)

104

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

An online-community based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have completed initial treatment. The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the patient's ability, opportunities, and motivation will be increased, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and promotion of healthy lifestyle. The intervention period is six weeks, with evaluations conducted at baseline, week three of the intervention, and week six of the intervention.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Survivor Rehabilitation Quality of Life	Behavioral: multidimensional rehabilitation	N/A

Detailed Description

After a patient is diagnosed with colorectal cancer, the tumour is completely controlled after a short period of treatment in hospital, and the patient returns to his or her family as a cancer survivor and begins a long period of recovery. However, due to the stress of surgery, the side effects of radiotherapy, chemotherapy and lifestyle changes, the quality of life of colorectal cancer survivors is often lower. Studies have shown that regular rehabilitation during or after cancer treatment can prolong survival, improve cardiorespiratory fitness, body composition and physical function, reduce fatigue, relieve anxiety and depression, and improve quality of life. However, there is a lack of comprehensive and systematic rehabilitation support for colorectal cancer survivors.

The main aim of our study is to establish a community multidimensional rehabilitation programme, to investigate its impact on improving outcome indicators such as quality of life, fear of recurrence and functional ability in colorectal cancer patients, to assess the feasibility and safety of this programme, and ultimately to establish a scalable community multidimensional rehabilitation programme for colorectal cancer.

We will conduct a randomised controlled trial at the First Affiliated Hospital of Xiamen University using a combination of online and offline recruitment. A total of 104 colorectal cancer survivors will be recruited. After obtaining informed consent from the survivors, the subjects will be numbered according to the order of inclusion, and simple random sampling will be performed using SPSS random number table method.

Patient inclusion criteria are: ① Completion of initial treatment for colon or rectal cancer (stage 1-3); Age 18 years or older, expected survival ≥6 months; Ability to walk without assistance; ④ No major surgery within the last 1 month; ⑤ Clear consciousness and normal intelligence; ⑥ Voluntary participation in this research and consent to medical record review; ⑦ Ability to use mobile phones. Inclusion criteria for patients: ⑧ Patients complained of functional impairment such as fatigue, anxiety, depression, loss of muscle strength, etc.

Patient exclusion criteria ① Those who did not know their own condition due to family members' request to conceal their condition; ② Patients with advanced colorectal cancer with distant metastasis, recurrence or multiple organ failure. Patients with multiple cancers. (4) Patients with severe psychological disorders, strict attention, hearing disorders and other influences of the intervention.

Exit criteria: ① Death during the study. ② Leaving the study for their own reasons.

After recruitment, written informed consent and oncologist's medical approval were obtained and baseline assessment was completed. The duration of the intervention was 6 weeks, with 3 weeks being 1 cycle.

The experimental group will explore multidimensional rehabilitation in the community. The intervention is based on the behaviour change wheel theory, and multidimensional rehabilitation intervention was implemented on the basis of family, including diet intervention, exercise intervention, psychological support, behaviour management and family support. Through training, education, motivation and other ways to increase patients' ability, opportunity and motivation, so as to increase the subjects' health behaviour and improve their quality of life. The control group receives routine care.

Quality of life, fear of relapse, healthy lifestyle, 30-second chair-stand test and BMI will be measured at baseline, week 3 and week 6. Patient persistence and discontinuation will be recorded throughout.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

patients were randomly assigned to the prehabilitation group and control group by online randomization softwarepatients were randomly assigned to the prehabilitation group and control group by online randomization software

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

Effect of Community Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: multidimensional rehabilitation group The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the patient's ability, opportunities, and motivation will be increased, thereby promoting healthy behavior.	Behavioral: multidimensional rehabilitation Multidimensional lifestyle interventions
No Intervention: Control group The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence.

Arm

Intervention/Treatment

Experimental: multidimensional rehabilitation group

The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior management. Through various methods such as training, education, and motivation, the patient's ability, opportunities, and motivation will be increased, thereby promoting healthy behavior.

Behavioral: multidimensional rehabilitation

Multidimensional lifestyle interventions

No Intervention: Control group

The patients will receive the conventional clinical guidance according to The First Affiliated Hospital of Xiamen University, including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence.

Outcome Measures

Primary Outcome Measures

Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [Change from Baseline at 6 weeks]
This Scale was developed to measure the quality of life of patients with cancer. It includes 30 questions and three sub-dimensions: General Well-Being, Functional Difficulties, and Symptom Control. The maximum score on the scale is 100, and the minimum is 0. High scores on the functional sub-dimension indicate good/healthy functional status, high scores on the symptom sub-dimension indicate high levels of symptoms and/or problems, and high scores on the global health status/quality of life sub-dimension indicate good quality of life.
Fear of Progression Questionaire-Short Form (FoP-Q-SF) [Change from Baseline at 6 weeks]
The FoP-Q-SF was developed by German scholar Herschbach in 2005 in people such as diabetes, rheumatic diseases and cancer, to measure patients' fear of disease progression or recurrence, a total of 7 dimensions, 43 entries, Cronbach's α is 0.7. It is a single-dimensional scale with a total of 12 items, using the Liket 5-level scoring method, the score range is 12~60, the higher the score, the higher the level of fear.

Secondary Outcome Measures

Health-Promoting Lifestyle Profile Il (HPLP II) [Change from Baseline at 6 weeks]
HPLP II is adapted and revised by American scholar Walker et al. according to the Kang-promoted lifestyle scale I, including self-actualization, health responsibility, exercise, nutrition, interpersonal support, stress coping 6 dimensions, a total of 52 items, each item adopts a 4-level scoring method, of which 1 means never, 2 means sometimes, 3 means often, 4 means always, the score is 52~208 points, the higher the score indicates the higher the level of healthy behavior, the total score of the scale is "52~90", "91~" 129", "130~168", "169~208" four range evaluation, "good" and "excellent" four grades.
HPLP II [Change from Baseline at 3 weeks]
HPLP II is adapted and revised by American scholar Walker et al. according to the Kang-promoted lifestyle scale I, including self-actualization, health responsibility, exercise, nutrition, interpersonal support, stress coping 6 dimensions, a total of 52 items, each item adopts a 4-level scoring method, of which 1 means never, 2 means sometimes, 3 means often, 4 means always, the score is 52~208 points, the higher the score indicates the higher the level of healthy behavior, the total score of the scale is "52~90", "91~" 129", "130~168", "169~208" four range evaluation, "good" and "excellent" four grades.
Family APGAR Index [Change from Baseline at 6 weeks]
APGAR will be used to assess the family functioning. It includes five aspects: fitness, cooperation, growth, affectivity, and intimacy, and adopts the Likert 3-level scoring method, and each item is assigned 0 points, 1 point, and 2 points from never, sometimes to often.
Family APGAR Index [Change from Baseline at 3 weeks]
APGAR will be used to assess the family functioning. It includes five aspects: fitness, cooperation, growth, affectivity, and intimacy, and adopts the Likert 3-level scoring method, and each item is assigned 0 points, 1 point, and 2 points from never, sometimes to often.
30-second Chair Sit-To-Stand (30-s STS) [Change from Baseline at 6 weeks]
Ability to test mobility and posture transposition. Using a chair without armrests, the number of times the participant could change from a sitting state (leaning back on the chair with both feet on the ground) to fully standing within 30 s was counted. Two tests were performed, with 1 min of rest in between, and the average value was rounded to the nearest value.
30-s STS [Change from Baseline at 3 weeks]
Ability to test mobility and posture transposition. Using a chair without armrests, the number of times the participant could change from a sitting state (leaning back on the chair with both feet on the ground) to fully standing within 30 s was counted. Two tests were performed, with 1 min of rest in between, and the average value was rounded to the nearest value.
BMI [Change from Baseline at 6 weeks]
BMI reflects the patient's nutritional status and physical fitness.
BMI [Change from Baseline at 3 weeks]
BMI reflects the patient's nutritional status and physical fitness.
Insulin-like Growth Factor-1 (IGF-1) [Change from Baseline at 6 weeks]
Insulin-like Growth Factor-1 (IGF-1)
Insulin-like growth factor binding-protein-3 (IGFBP-3) [Change from Baseline at 6 weeks]
Insulin-like growth factor binding-protein-3 (IGFBP-3)
Fasting blood glucose [Change from Baseline at 6 weeks]
Fasting blood glucose
High-Density Lipoprotein (HDL) [Change from Baseline at 6 weeks]
High-Density Lipoprotein (HDL)
Triglycerides [Change from Baseline at 6 weeks]
Triglycerides
Cholesterol [Change from Baseline at 6 weeks]
Cholesterol
Low-Density Lipoprotein (LDL) [Change from Baseline at 6 weeks]
Low-Density Lipoprotein (LDL)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Complete the primary treatment for colon cancer or rectal cancer (stage 1-3);
Age 18 years old and under 65 years old, estimated survival period ≥ 6 months;
be able to walk without assistance;
Conscious and intellectually normal;
Voluntarily participate in the research of this topic and provide the consent form for medical record review;
Mobile phones can be used.

Exclusion Criteria:

unaware of their own condition because their family members have requested that their illness be concealed;
Patients with advanced colorectal cancer with distant metastasis, recurrence or multi-organ failure.
Patients with multiple cancers.
Patients with severe psychological disorders, severe visual impairment, hearing impairment and other effects on intervention.