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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000046186
Receipt No. R000051671
Scientific Title An Observational Study of Follow-up for Symptomatic Adverse Events Using ePRO in Gastrointestinal Cancer Patients after Starting Oral Anticancer Therapy in Pharmacy
Date of disclosure of the study information 2021/11/25
Last modified on 2021/11/25

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Basic information
Public title An Observational Study of Follow-up for Symptomatic Adverse Events Using ePRO in Gastrointestinal Cancer Patients after Starting Oral Anticancer Therapy in Pharmacy
Acronym FORECAST study
Scientific Title An Observational Study of Follow-up for Symptomatic Adverse Events Using ePRO in Gastrointestinal Cancer Patients after Starting Oral Anticancer Therapy in Pharmacy
Scientific Title:Acronym FORECAST study
Region
Japan

Condition
Condition colon cancer, gastric cancer, pancreas cancer, biliary tract cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 In this study, symptom-related adverse events experienced by cancer patients visiting a pharmacy while taking oral anticancer drugs will be collected electronically using PRO-CTCAE, a Patient-Reported Outcome (PRO).
The primary objective is to determine the occurrence of symptom-related adverse events during the observation period (from the start of medication until the 12-week point).
The secondary objectives are to determine the rate and details of patient follow-up by pharmacy pharmacists during the observation period and to examine the association between follow-up and symptom-related adverse events, adherence, and satisfaction. In addition, we will divide the patients into two groups, one with ePRO follow-up and the other with usual follow-up, and examine the differences in the rate of follow-up, adherence, and satisfaction.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To estimate point estimates and 95% confidence intervals for the rate of the worst symptom-related adverse events at 12 weeks.
Key secondary outcomes In the ePRO follow-up group,
1. To estimate the point estimate and 95% confidence interval of the rate of symptom-related adverse events at each time point of weeks 1-12
2. To estimate the rate of PRO-CTCAE input, the rate of PRO-CTCAE input results viewed, and the rate of follow-up at each time point of week 1-12, and for 12 weeks (week 1-12)
3. To examine the relationship between the rate of PRO-CTCAE input at 12 weeks (week 1-12) and the ASK-12, CTSQ scores, and MPR

In the ePRO follow-up group and the usual follow-up group,
1. To compare the follow-up rate at each time point of week 1-12 and the rate for 12 weeks (week 1-12)
2. To compare the number of tracing reports for 12 weeks (week 1-12)
3. To compare ASK-12 and CTSQ scores and MPR
4. To examine the relationship between the rate of 12-week (week 1-12) follow-up and ASK-12, CTSQ scores, and MPR
5. To summarize instructional content as descriptive statistics

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. 20 years old or older
2. have been diagnosed with colorectal, gastric, pancreatic, or biliary tract cancer
3. Treatment with S-1 or capecitabine will be initiated
4. Patient's written consent for participation in the study has been obtained.
Key exclusion criteria 1. Severe mental illness
2. have cognitive impairment that may affect their ability to complete the questionnaire
3. Native language is not Japanese
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Ryohei
Middle name
Last name Soeishi
Organization Hachioji Pharmaceutical Center
Division name Pharmacy
Zip code 193-0944
Address 1097, Tatemachi, Hachioji-city, Tokyo 193-0944 Japan
TEL 042-666-0931
Email ryohei-soeishi@pharma802.com

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Oakada
Organization Hachioji Pharmaceutical Center Pharmacy
Division name Pharmacy
Zip code 193-0944
Address 1097, Tatemachi, Hachioji-city, Tokyo 193-0944 Japan
TEL 042-666-0931
Homepage URL
Email kaisyaizo@gmail.com

Sponsor
Institute Hachioji Pharmaceutical Center Pharmacy
Institute
Department

Funding Source
Organization ealth Labour Sciences Research Grant Research on Policy Planning and Evaluation
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Tohoku University
Tokyo University of Pharmacy and Life Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Pharmaceutical Association
Address 1-21, Kanda Nishiki-cho, Chiyoda-ku, Tokyo 101-0054 Japan
Tel 03-3294-0271
Email druginfo@toyaku.or.jp

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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 25 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2021 Year 07 Month 07 Day
Date of IRB
2021 Year 11 Month 09 Day
Anticipated trial start date
2021 Year 11 Month 25 Day
Last follow-up date
2023 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a single-center observational study to introduce adverse event assessment by ePRO into patient follow-up by pharmacists. Cancer patients taking oral anticancer drugs will be surveyed weekly for adverse events by ePRO from the baseline medication initiation to 12 weeks. This will be the ePRO follow-up group. If ePRO cannot be introduced to the subject, the usual follow-up will be conducted after investigating the reason. ePRO follow-up group and usual follow-up group will be surveyed for adherence and satisfaction, which will be conducted using paper media in the usual follow-up group. Patient follow-up will be conducted as a routine medical treatment and dispensing of medication, medication guidance, and pharmacological management guidance will also be conducted as routine medical treatment.

Management information
Registered date
2021 Year 11 Month 25 Day
Last modified on
2021 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051671

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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