Colorectal Cancer SurvivorNCT05956990
Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors
A study testing multidimensional rehabilitation in people with Colorectal Cancer Survivor and Rehabilitation, run by Qu Shen.
Trial summary
A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. The intervention is based on the behavior change wheel and includes dietary intervention, exercise intervention, psychological support, and behavior… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer Survivor, Rehabilitation, Quality of Life
- What is being tested?
- multidimensional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing adjuvant therapy after curative surgery for colorectal cancer.;
- Age 18 years old and under 65 years old, estimated survival period ≥ 6 months;
- PG-SGA (Patient-Generated Subjective Global Assessment) score less than 4.
- 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.
Who cannot join
- Patients with multiple cancers.
- Tumors not completely resected.
- Patients with severe psychological disorders, severe visual or hearing impairments, or other conditions that hinder intervention.
- Patients with severe complications such as short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis, previous stroke, congestive heart failure or edema, liver or kidney failure, or other conditions that affect patient compliance.
- In addition to colorectal cancer or any other diseases deemed unsuitable for participation by the researchers, patients with severe heart, liver, lung, or kidney diseases.
- Patients with special dietary requirements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Metaverse-based Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors
A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. 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 program aims to enhance the patients' functional ability, opportunities, and motivation, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and adoption of a healthy lifestyle. The intervention period is 4 weeks, with evaluations conducted at baseline and week 4 of the intervention
- Conditions
- Colorectal Cancer Survivor, Rehabilitation, Quality of Life
- Being tested
- multidimensional rehabilitation
- Keywords
- colorectal cancer survivor, Rehabilitation, Quality of Life, Fear of cancer recurrence, lifestyle, home-based
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multidimensional rehabilitationBehavioural
Multidimensional lifestyle interventions
| Study group | Role | What they receive |
|---|---|---|
| multidimensional rehabilitation group | Experimental | 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. Receives: Behavioral: multidimensional rehabilitation |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline at 4 weeks
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.
Measured: Change from Baseline at 4 weeks
Secondary outcomes (9)
Lifestyle
Assessments of lifestyle behaviors will be conducted using a self-developed behavior scale, focusing on the frequency of behaviors such as diet and smoking.
Measured: Change from Baseline at 4 weeks
The International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) is a commonly used tool for assessing individuals' levels of physical activity in their daily lives. It aims to measure individuals' physical activity over the past 7 days, including overall physical activity levels and the frequency of activities.
Measured: Change from Baseline at 4 weeks
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.
Measured: Change from Baseline at 4 weeks
BMI
BMI reflects the patient's nutritional status and physical fitness.
Measured: Change from Baseline at 4 weeks
Chemotherapy completion rate
Chemotherapy completion rate
Measured: 4th week
White blood cell count
White blood cell count
Measured: Change from Baseline at 4 weeks
Red blood cell count
Red blood cell count
Measured: Change from Baseline at 4 weeks
Hemoglobin concentration
Hemoglobin concentration
Measured: Change from Baseline at 4 weeks
Platelet count
Platelet count
Measured: Change from Baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Jul 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer SurvivorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients were randomly assigned to the rehabilitation group and control group by online randomization software
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qu Shen
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University
- Responsible party
- Sponsor-investigator, Qu Shen, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956990
- Sponsor's protocol ID
- XiamenUYHu
- Status last verified
- Mar 2024
- First submitted
- 4 Jul 2023
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Hu Y, Peng H, Su G, Chen B, Yang Z, Ye Y, Zhou B, Lin S, Deng H, Zhang J, Xie Y, He H, Ruan Z, Shen Q. Effect of a metaverse multimodal rehabilitation intervention on quality of life and fear of recurrence in patients with colorectal cancer survivors: A randomized controlled study protocol. Digit Health. 2024 Nov 18;10:20552076241295542. doi: 10.1177/20552076241295542. eCollection 2024 Jan-Dec.
PubMed 39564355
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metaverse-based Multidimensional Rehabilitation Intervention on Quality of Life and Fear of Recurrence in Colorectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT05956990
- Acronym / sponsor ID
- XiamenUYHu
- Conditions
- Colorectal Cancer Survivor, Rehabilitation, Quality of Life
- Keywords
- colorectal cancer survivor, Rehabilitation, Quality of Life, Fear of cancer recurrence, lifestyle, home-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Qu ShenUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A metaverse-based multidimensional rehabilitation program will be implemented for colorectal cancer survivors who have undergone curative surgery and adjuvant therapy. 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 program aims to enhance the patients' functional ability, opportunities, and motivation, thereby promoting healthy behavior. Outcome measures include quality of life, fear of recurrence, and adoption of a healthy lifestyle. The intervention period is 4 weeks, with evaluations conducted at baseline and week 4 of the intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- patients were randomly assigned to the rehabilitation group and control group by online randomization software
| Arm | Type | Receives |
|---|---|---|
| multidimensional rehabilitation group | Experimental | Behavioral: multidimensional rehabilitationThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients undergoing adjuvant therapy after curative surgery for colorectal cancer.;
- Age 18 years old and under 65 years old, estimated survival period ≥ 6 months;
- PG-SGA (Patient-Generated Subjective Global Assessment) score less than 4.
- Be able to walk without assistance;
- Conscious and intellectually normal;
Key exclusion criteria (6 listed)
- Patients with multiple cancers.
- Tumors not completely resected.
- Patients with severe psychological disorders, severe visual or hearing impairments, or other conditions that hinder intervention.
- Patients with severe complications such as short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis, previous stroke, congestive heart failure or edema, liver or kidney failure, or other conditions that affect patient compliance.
- In addition to colorectal cancer or any other diseases deemed unsuitable for participation by the researchers, patients with severe heart, liver, lung, or kidney diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multidimensional rehabilitationMultidimensional lifestyle interventions | Behavioural | multidimensional rehabilitation group |
Primary outcome
Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Change from Baseline at 4 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)
Time frame: Change from Baseline at 4 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.
9 secondary outcomes
Lifestyle
Time frame: Change from Baseline at 4 weeks
The International Physical Activity Questionnaire (IPAQ)
Time frame: Change from Baseline at 4 weeks
30-second Chair Sit-To-Stand (30-s STS)
Time frame: Change from Baseline at 4 weeks
BMI
Time frame: Change from Baseline at 4 weeks
Chemotherapy completion rate
Time frame: 4th week
White blood cell count
Time frame: Change from Baseline at 4 weeks
Red blood cell count
Time frame: Change from Baseline at 4 weeks
Hemoglobin concentration
Time frame: Change from Baseline at 4 weeks
Platelet count
Time frame: Change from Baseline at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Derived from this study: PubMed 39564355Hu Y, Peng H, Su G, Chen B, Yang Z, Ye Y, Zhou B, Lin S, Deng H, Zhang J, Xie Y, He H, Ruan Z, Shen Q. Effect of a metaverse multimodal rehabilitation intervention on quality of life and fear of recurrence in patients with colorectal cancer survivors: A randomized controlled study protocol. Digit Health. 2024 Nov 18;10:20552076241295542. doi: 10.1177/20552076241295542. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: Yes
Related trials for Colorectal Cancer Survivor
RecruitingPhase 3
Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Not yet recruiting
Mind-Body Interventions for the Improvement of Quality of Life, Stress, and Sleep Quality Among Survivors of Breast, Prostate, Endometrial, or Colorectal Cancer
Breast Cancer Stage I, Colorectal Cancer
Recruiting
Low Load Blood Flow Restriction Resistance Training in Colorectal Cancer Related Sarcopenia
Colorectal Cancer Survivors
RecruitingObservational study
Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies
Prostate Cancer, Liver Cancer
Active, not recruiting
Improving Nutrition and Physical Activity for Cancer Survivors (Tools To Be Fit)
Bladder Cancer, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing multidimensional rehabilitation in people with Colorectal Cancer Survivor and Rehabilitation, run by Qu Shen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qu Shen (+865922189613, shenqumail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) (time frame: Change from Baseline at 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.