UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060942 |
|---|---|
| Receipt number | R000069743 |
| Scientific Title | Patient and Family Financial burden in Life |
| Date of disclosure of the study information | 2026/03/16 |
| Last modified on | 2026/03/16 13:04:57 |
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Basic information
Public title
Patient and Family Financial burden in Life
Acronym
PaFFL
Scientific Title
Patient and Family Financial burden in Life
Scientific Title:Acronym
PaFFL
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to clarify the current status and impact of financial toxicity associated with cancer treatment from the perspectives of both patients and their families. Through a multicenter questionnaire survey, the degree of financial toxicity experienced by patients and family members will be quantified using the Japanese version of the Comprehensive Score for Financial Toxicity (COST). The study will also evaluate the impact of financial toxicity on daily life, employment, psychological well-being, and treatment continuity. In addition, the social and psychological burden experienced by family members supporting patients, as well as the utilization and needs of support resources such as counseling and patient support centers, will be investigated. The findings of this study aim to provide comprehensive evidence on the current state of financial toxicity in Japan and contribute to the improvement of support systems and policy development for patients with cancer and their families.
Basic objectives2
Others
Basic objectives -Others
In addition to assessing the extent of financial toxicity associated with cancer treatment, this study aims to comprehensively evaluate the social, psychological, and lifestyle impacts experienced by patients and their families. Specifically, the study will investigate changes in employment status, the impact on household finances, perceptions of medical expenses, psychological burden, and the utilization and needs of patient support resources such as counseling and patient support centers. Furthermore, exploratory analyses will be conducted to examine associations between financial toxicity and patient characteristics, including age, cancer type, treatment modalities, and socioeconomic background. Through these analyses, the study aims to provide a multidimensional understanding of financial toxicity among patients with cancer and their families in Japan and to generate evidence that may contribute to the development of future support systems and policy initiatives.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the degree of financial toxicity assessed using the Japanese version of the Comprehensive Score for Financial Toxicity (COST).
Financial toxicity will be evaluated based on COST scores obtained from the questionnaire survey, and the distribution and severity of financial toxicity among patients with cancer and their family members will be analyzed.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with cancer who are receiving or have received cancer treatment
Individuals able to respond to the questionnaire
Individuals who provide written or electronic informed consent
Family members or primary caregivers supporting patients with cancer
Key exclusion criteria
Individuals who are unable to complete the questionnaire as judged by the investigator
Individuals who do not provide informed consent
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Honda |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL
052-762-6111
khonda@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Honda |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi
TEL
052-762-6111
Homepage URL
khonda@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Cancer Center
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi
Tel
052-762-6111
khonda@aichi-cc.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
| 2026 | Year | 03 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter observational study conducted using a questionnaire survey. The study aims to evaluate financial toxicity associated with cancer treatment among patients with cancer and their family members. Participants will complete questionnaires including the Japanese version of the Comprehensive Score for Financial Toxicity (COST) to assess the degree of financial toxicity. Additional information regarding patient characteristics, employment status, financial burden related to medical expenses, psychological burden, and utilization of support resources will also be collected. The study will be conducted within routine clinical practice and does not involve any intervention.
Management information
Registered date
| 2026 | Year | 03 | Month | 16 | Day |
Last modified on
| 2026 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069743
