UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044887 |
|---|---|
| Receipt number | R000051269 |
| Scientific Title | Effectiveness of hospital-based case management intervention on Chinese colorectal cancer patients |
| Date of disclosure of the study information | 2021/07/17 |
| Last modified on | 2021/07/17 11:59:32 |
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Basic information
Public title
Effectiveness of hospital-based case management intervention on Chinese colorectal cancer patients
Acronym
CM
Scientific Title
Effectiveness of hospital-based case management intervention on Chinese colorectal cancer patients
Scientific Title:Acronym
Effectiveness of hospital-based case management intervention on Chinese colorectal cancer patients
Region
| Asia(except Japan) |
Condition
Condition
colorectal cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to propose a CM intervention that is suitable for Chinese colorectal cancer patients and explore the effectiveness over 12-month follow up.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
quality of life was measured at baseline (T0), three days after operation (T1), the first stage (T2-1), middle stage (T2-2) and last stage of chemotherapy (T2-3), and the end of one-year intervention (T3).
Key secondary outcomes
Anxiety and depression and symptom distress are measured at six time points same as quality of life. Overall treatment adherence was calculated at the end of T3. Oral chemotherapy adherence was measured at T2-1, T2-2 and T2-3 of chemotherapy. Unplanned readmission rates were measured at the end of T1, T2 and T3.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
intervention group was managed for one year by case manager, who organized multidisciplinary team, provided regular assessment, consulting service, and referrals.
Interventions/Control_2
routine care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Diagnosed with colorectal cancer through histopathology; (2) Aged between 18 and 65 years old; (3) Treated for the first time and accepted adjuvant chemotherapy; (4) Patients with an expected survival time >1 year; (5) willing to participate with informed consent.
Key exclusion criteria
(1) patients without the ability of reading, writing and understanding of Chinese; (2) Patients with metastasis or recurrence; (3) Diagnosed with an advanced stage of cancer and accepted palliative therapy; (4) Patients with severe cardiopulmonary function disorders, such as heart function level 3 and above, COPD, level 3 hypertension; (5) Patients with psychiatric history.
Target sample size
156
Research contact person
Name of lead principal investigator
| 1st name | Meifen |
| Middle name | |
| Last name | Zhang |
Organization
Sun Yat-sen University
Division name
School of Nursing
Zip code
510080
Address
School of Nursing, Sun Yat-sen University, 74, Zhongshan 2nd Rd., Guangzhou 510080, China.
TEL
(+86)13416225022
zhmfen@mail.sysu.edu.cn
Public contact
Name of contact person
| 1st name | Meifen |
| Middle name | |
| Last name | Zhang |
Organization
Sun Yat-sen University
Division name
School of Nursing
Zip code
510080
Address
School of Nursing, Sun Yat-sen University, 74, Zhongshan 2nd Rd., Guangzhou 510080, China.
TEL
(+86)13416225022
Homepage URL
zhmfen@mail.sysu.edu.cn
Sponsor or person
Institute
Department of Finance of Guangdong Province
Institute
Department
Personal name
Funding Source
Organization
Department of Finance of Guangdong Province
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
China
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sun Yat-sen University Cancer Center
Address
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou 510060, China.
Tel
020-87343392
wxdzhongda@163.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Sun Yat-sen University (China)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
188
Results
85 patients in control group and 80 patients in CM group were recruited. Repeated measurement ANOVA showed that significant intervention effect and time effect in global quality of life, anxiety and depression, symptom distress, oral chemotherapy adherence (p<0.05). The CM group showed statistically significantly better overall treatment adherence and lower unplanned readmission rate (p<0.05).
Results date posted
| 2021 | Year | 07 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Comparison of the demographic and clinic characteristics between participants who completed and who dropped out was presented in table 2. No significant difference was observed. As shown in table 2 and 3, there were no significant differences between the CM and control group on baseline assessment of demographic, clinic characteristics and outcome variables.
Participant flow
188 participants were preliminary included after eligibility screening, all of which consented to participate. 23 participants discontinued the follow-up because of lost connection (n=14), joining another research (n=5), and passing away (n=4). 165 participants were eventually included into data analysis (attrition rate: 12.2%).
Adverse events
none
Outcome measures
Plan to share IPD
none
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2021 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051269
