UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046186 |
|---|---|
| Receipt number | 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 | 2024/05/27 13:49:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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, depending on the availability of electronic PRO (ePRO) input, the follow-up group will be divided into two groups, the ePRO follow-up group and the usual follow-up group, to examine 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 follow-up details 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
77
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
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
kaisyaizo@gmail.com
Sponsor or person
Institute
Hachioji Pharmaceutical Center Pharmacy
Institute
Department
Personal name
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
Tokyo University of Pharmacy and Life Sciences Pharmacy
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
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
八王子薬剤センター薬局（東京都）、東京薬科大学附属薬局（東京都）
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
No longer recruiting
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
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051671
