UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060098 |
|---|---|
| Receipt number | R000068732 |
| Scientific Title | Effectiveness and safety of home-visiting chemotherapy in patients with unresectable or recurrent cancer and difficulty visiting hospitals: a single-center retrospective observational study (INDEPENDENCE Study) |
| Date of disclosure of the study information | 2025/12/16 |
| Last modified on | 2025/12/16 15:07:35 |
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Basic information
Public title
Effectiveness and safety of home-visiting chemotherapy for advanced cancer patients with difficulty receiving hospital-based chemotherapy
Acronym
INDEPENDENCE Study
Scientific Title
Effectiveness and safety of home-visiting chemotherapy in patients with unresectable or recurrent cancer and difficulty visiting hospitals: a single-center retrospective observational study (INDEPENDENCE Study)
Scientific Title:Acronym
INDEPENDENCE Study
Region
| Japan |
Condition
Condition
Unresectable advanced cancer
Classification by specialty
| Hematology and clinical oncology | Geriatrics | Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate the effectiveness and safety of home-visiting chemotherapy provided as part of routine clinical practice in patients with unresectable advanced cancer not considered eligible for hospital-based chemotherapy, and to identify prognostic factors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Objective response rate, disease control rate, and adverse events
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.Age 20 years or older at the start of treatment.
2.Diagnosis of malignancy based on histology, cytology, or imaging studies.
3.Clinical diagnosis of unresectable advanced cancer.
4.Difficulty in attending hospital-based chemotherapy, with prior clinical decision for palliative care or inability to receive outpatient chemotherapy.
5.First home-visit medical care at the study institution between July 1, 2023 and March 31, 2025.
Key exclusion criteria
1.Patients expressing refusal to participate through the opt-out process.
2.Patients considered inappropriate for the study by the principal investigator.
Target sample size
142
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Tsuruta |
Organization
Tendai Medical Corporation, Tsuruta Clinic
Division name
Department of Medical Oncology
Zip code
810-0044
Address
2F-10, Vivace Hashimoto, 4-11-26 Ropponmatsu, Chuo-ku, Fukuoka-shi, Fukuoka 810-0044, Japan
TEL
092-791-7891
ntsuruta1102@gmail.com
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Tsuruta |
Organization
Tendai Medical Corporation, Tsuruta Clinic
Division name
Department of Medical Oncology
Zip code
810-0044
Address
2F-10, Vivace Hashimoto, 4-11-26 Ropponmatsu, Chuo-ku, Fukuoka-shi, Fukuoka 810-0044, Japan
TEL
092-791-7891
Homepage URL
https://www.tsuruta-cl.com/cancer/optout/
ntsuruta1102@gmail.com
Sponsor or person
Institute
Tendai Medical Corporation, Tsuruta Clinic
Institute
Department
Personal name
Nobuhiro Tsuruta
Funding Source
Organization
None (This study received no specific funding.)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Tendai Medical Corporation
Address
2F-10, Vivace Hashimoto, 4-11-26 Ropponmatsu, Chuo-ku, Fukuoka-shi, Fukuoka 810-0044, Japan
Tel
092-791-7891
ntsuruta1102@gmail.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
鶴田クリニック（福岡県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | 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
142
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
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single-center retrospective observational study using existing medical records. No additional interventions or data collection were performed.
Management information
Registered date
| 2025 | Year | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068732
