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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044887
Receipt No. 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

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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
Email 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
Email zhmfen@mail.sysu.edu.cn

Sponsor
Institute Department of Finance of Guangdong Province
Institute
Department

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
Email 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
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051269

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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