Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study

Sponsor

Qu Shen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05957289

Collaborator

The First Affiliated Hospital of Xiamen University (Other)

Enrollment

Arm

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
Rehabilitation Colorectal Cancer Survivor Quality of Life Pilot Study	Behavioral: multidimensional rehabilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 30, 2023

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

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

Outcome Measures

Primary Outcome Measures

Number of adverse events [6th week]
Record the occurrence of adverse events, including nausea, vomiting, pain, etc.
Adherence [6th week]
The number of days per week that participants complied with the protocol will be recorded over a 6-week period.
Viability [6th week]
Record the number and reasons for loss to follow-up
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.
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.
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.
BMI [Change from Baseline at 6 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
LowDensity Lipoprotein (LDL) [Change from Baseline at 6 weeks]
LowDensity Lipoprotein (LDL)
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

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.