RehabilitationNCT05957289
Multidimensional Rehabilitation Intervention in Colorectal Cancer Survivors - a Pilot Study
A study testing multidimensional rehabilitation in people with Rehabilitation and Colorectal Cancer Survivor, 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
- Rehabilitation, Colorectal Cancer Survivor, 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
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Dec 2024
- 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 Pilot Study
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.
- 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Record the occurrence of adverse events, including nausea, vomiting, pain, etc.
Measured: 4th week
Adherence
The number of days per week that participants complied with the protocol will be recorded over a 4-week period.
Measured: 4th week
Viability
Record the number and reasons for loss to follow-up
Measured: 4th week
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 (5)
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
Semi-structured interviews
After the intervention, semi-structured interviews were conducted with the participants. The main topics covered included the benefits and adverse reactions of the multidimensional rehabilitation intervention, factors that facilitated or hindered participation in the multidimensional rehabilitation, and the pros and cons of the metaverse platform.
Measured: 4th week
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 Jun 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05957289
- Sponsor's protocol ID
- XiamenUSQ
- Status last verified
- Mar 2024
- First submitted
- 13 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
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 - a Pilot Study
- ClinicalTrials.gov ID
- NCT05957289
- Acronym / sponsor ID
- XiamenUSQ
- Keywords
- Colorectal cancer survivor, Rehabilitation, Quality of Life, Fear of cancer recurrence, Lifestyle, Home-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Qu ShenUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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. |
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
Number of adverse events
Time frame: 4th week
Record the occurrence of adverse events, including nausea, vomiting, pain, etc.
Adherence
Time frame: 4th week
The number of days per week that participants complied with the protocol will be recorded over a 4-week period.
Viability
Time frame: 4th 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)
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.
5 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
Semi-structured interviews
Time frame: 4th week
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.
- Individual participant dataSharing planned: Yes
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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 Rehabilitation and Colorectal Cancer Survivor, 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?
Number of adverse events (time frame: 4th week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.