UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051315 |
|---|---|
| Receipt number | R000058534 |
| Scientific Title | Smartphone Acceptance and commitment therapy to Keep mind sUpple for Relief of post mAstectomy pain syndrome in breast cancer patients: A randomized controlled trial using an innovative decentralized platform (preliminary study) |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2023/06/12 06:23:36 |
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Basic information
Public title
Smartphone Acceptance and commitment therapy to Keep mind sUpple for Relief of post mAstectomy pain syndrome in breast cancer patients: A randomized controlled trial using an innovative decentralized platform (preliminary study)
Acronym
Smartphone Acceptance and commitment therapy to Keep mind sUpple for Relief of post mAstectomy pain syndrome in breast cancer patients (SAKURA Project)
Scientific Title
Smartphone Acceptance and commitment therapy to Keep mind sUpple for Relief of post mAstectomy pain syndrome in breast cancer patients: A randomized controlled trial using an innovative decentralized platform (preliminary study)
Scientific Title:Acronym
Smartphone Acceptance and commitment therapy to Keep mind sUpple for Relief of post mAstectomy pain syndrome in breast cancer patients (SAKURA Project)
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conduct a randomized controlled trial to verify the effectiveness of smartphone ACT for PMPS. At the same time, we will develop a fully decentralized clinical trial infrastructure that allows patients to participate in trials without the need to visit the hospital and to obtain patient-reported outcomes remotely. This study examines feasibility and preliminary utility in a small pilot study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Preliminary usefulness
Pain Intensity and Disability: Brief Pain Inventory (BPI)
Intensity of fatigue and numbness: M.D.Anderson Symptom Inventory (MDASI)
Pain Acceptance: Chronic Pain Acceptance Questionnaire (CPAQ)
Fear of recurrence: Fear of Cancer Recurrence Inventory-short form: (FCRI-SF)
Work Productivity: Work Productivity and Activity Impairment Questionnaire (WPAI)
Anxiety/depression: Hospital Anxiety and Depression Scale (HADS)
Psychological Flexibility: Acceptance and Action Questionnaire 2: (AAQ-2)
Acting on Values: Valuing Questionnaire (VQ)
Quality of Life: EuroQol-5-Deimensions (EQ5D)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Eight-week smartphone cognitive-behavioral therapy for post-mastectomy pain syndrome in breast cancer patients
Interventions/Control_2
Usual treatment group
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
Female
Key inclusion criteria
1. Have been diagnosed with breast cancer
2. Patients with no recurrence more than 1 year after breast cancer surgery
3. 18 years old or older at the time of obtaining consent
4. Having PMPS (postoperative pain in the surgical site, armpit, arm on the side of surgery), or site related to reconstructive surgery (reconstructive site and back or abdomen undergoing surgery for reconstruction, etc.) ) pain persists 1 year after reconstructive surgery
5. Smartphone users: Patients who can install the app by themselves on Android or iOS mobile terminals that can use the app and can use it during the study period (OS version: iOS 13.0 or higher, Android 6.0 or higher)
Key exclusion criteria
1. Cannot read or write Japanese
2. Patients who have pain caused by causes other than cancer and are receiving treatment.
3. Patients who have pain in areas other than wounds, armpits, and arms and are undergoing treatment.
4. Patients with mental symptoms that the investigator/co-investigator judges inappropriate for participation, such as dementia/cognitive dysfunction, severe depression with suicidal ideation, poorly controlled schizophrenia, and schizoaffective disorder.
5. Patients who have serious physical diseases (serious respiratory diseases, cardiovascular diseases, central/peripheral nerve diseases, muscular/skeletal diseases, etc.) and are difficult to receive psychological therapy.
6. Patients who have received ACT in the past
7. Other patients who are judged to be inappropriate by the researcher/co-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuo |
| Middle name | |
| Last name | Akechi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Dept. of Psychiatry and cognitive Behavioral Medicine
Zip code
4678601
Address
Mizuho-cho, Mizuho-ku Nagoya Aichi
TEL
052-853-8271
takechi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Akechi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Dept. of Psychiatry and cognitive Behavioral Medicine
Zip code
4678601
Address
Mizuho-cho, Mizuho-ku Nagoya Aichi
TEL
052-853-8271
Homepage URL
https://sakura-pj.org/about/
takechi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Tatsuo Akechi
Funding Source
Organization
Japan Agency for Medical Research and Development Research Fund
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Ethics Research Review Committee
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi Japan
Tel
052-853-8346
rinshou-kenkyu@med.nagoya-cu.ac.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
名古屋市立大学病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 12 | 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
| 2022 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058534
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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