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Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors

Primary Purpose

Colorectal Cancer Survivor, Rehabilitation, Quality of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
multidimensional rehabilitation
Sponsored by
Qu Shen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer Survivor focused on measuring colorectal cancer survivor, Rehabilitation, Quality of Life, Fear of cancer recurrence, lifestyle, home-based

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    multidimensional rehabilitation group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    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)
    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)
    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
    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
    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
    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)
    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
    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
    BMI reflects the patient's nutritional status and physical fitness.
    BMI
    BMI reflects the patient's nutritional status and physical fitness.
    Insulin-like Growth Factor-1 (IGF-1)
    Insulin-like Growth Factor-1 (IGF-1)
    Insulin-like growth factor binding-protein-3 (IGFBP-3)
    Insulin-like growth factor binding-protein-3 (IGFBP-3)
    Fasting blood glucose
    Fasting blood glucose
    High-Density Lipoprotein (HDL)
    High-Density Lipoprotein (HDL)
    Triglycerides
    Triglycerides
    Cholesterol
    Cholesterol
    Low-Density Lipoprotein (LDL)
    Low-Density Lipoprotein (LDL)

    Full Information

    First Posted
    July 4, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Qu Shen
    Collaborators
    The First Affiliated Hospital of Xiamen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05956990
    Brief Title
    Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors
    Official Title
    Effect of Community Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Qu Shen
    Collaborators
    The First Affiliated Hospital of Xiamen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer Survivor, Rehabilitation, Quality of Life
    Keywords
    colorectal cancer survivor, Rehabilitation, Quality of Life, Fear of cancer recurrence, lifestyle, home-based

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    patients were randomly assigned to the prehabilitation group and control group by online randomization software
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    104 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    multidimensional rehabilitation group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    multidimensional rehabilitation
    Intervention Description
    Multidimensional lifestyle interventions
    Primary Outcome Measure Information:
    Title
    Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    Description
    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.
    Time Frame
    Change from Baseline at 6 weeks
    Title
    Fear of Progression Questionaire-Short Form (FoP-Q-SF)
    Description
    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.
    Time Frame
    Change from Baseline at 6 weeks
    Secondary Outcome Measure Information:
    Title
    Health-Promoting Lifestyle Profile Il (HPLP II)
    Description
    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.
    Time Frame
    Change from Baseline at 6 weeks
    Title
    HPLP II
    Description
    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.
    Time Frame
    Change from Baseline at 3 weeks
    Title
    Family APGAR Index
    Description
    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.
    Time Frame
    Change from Baseline at 6 weeks
    Title
    Family APGAR Index
    Description
    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.
    Time Frame
    Change from Baseline at 3 weeks
    Title
    30-second Chair Sit-To-Stand (30-s STS)
    Description
    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.
    Time Frame
    Change from Baseline at 6 weeks
    Title
    30-s STS
    Description
    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.
    Time Frame
    Change from Baseline at 3 weeks
    Title
    BMI
    Description
    BMI reflects the patient's nutritional status and physical fitness.
    Time Frame
    Change from Baseline at 6 weeks
    Title
    BMI
    Description
    BMI reflects the patient's nutritional status and physical fitness.
    Time Frame
    Change from Baseline at 3 weeks
    Title
    Insulin-like Growth Factor-1 (IGF-1)
    Description
    Insulin-like Growth Factor-1 (IGF-1)
    Time Frame
    Change from Baseline at 6 weeks
    Title
    Insulin-like growth factor binding-protein-3 (IGFBP-3)
    Description
    Insulin-like growth factor binding-protein-3 (IGFBP-3)
    Time Frame
    Change from Baseline at 6 weeks
    Title
    Fasting blood glucose
    Description
    Fasting blood glucose
    Time Frame
    Change from Baseline at 6 weeks
    Title
    High-Density Lipoprotein (HDL)
    Description
    High-Density Lipoprotein (HDL)
    Time Frame
    Change from Baseline at 6 weeks
    Title
    Triglycerides
    Description
    Triglycerides
    Time Frame
    Change from Baseline at 6 weeks
    Title
    Cholesterol
    Description
    Cholesterol
    Time Frame
    Change from Baseline at 6 weeks
    Title
    Low-Density Lipoprotein (LDL)
    Description
    Low-Density Lipoprotein (LDL)
    Time Frame
    Change from Baseline at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qu Shen
    Phone
    +865922189613
    Email
    shenqumail@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors

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