UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059180 |
|---|---|
| Receipt number | R000067689 |
| Scientific Title | Development and Efficacy of Smartphone-Based Psychotherapy for Post-Mastectomy Pain Syndrome: A Multicenter, Sham-Controlled, Double-Blind, Randomized Parallel-Group Trial Using a Decentralized Clinical Trial Platform |
| Date of disclosure of the study information | 2025/09/24 |
| Last modified on | 2025/09/24 22:23:11 |
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Basic information
Public title
Development and Efficacy of Smartphone-Based Psychotherapy for Post-Mastectomy Pain Syndrome: A Multicenter, Sham-Controlled, Double-Blind, Randomized Parallel-Group Trial Using a Decentralized Clinical Trial Platform
Acronym
Development and Efficacy of Smartphone-Based Psychotherapy for Post-Mastectomy Pain Syndrome: A Multicenter, Sham-Controlled, Double-Blind, Randomized Parallel-Group Trial Using a Decentralized Clinical Trial Platform
Scientific Title
Development and Efficacy of Smartphone-Based Psychotherapy for Post-Mastectomy Pain Syndrome: A Multicenter, Sham-Controlled, Double-Blind, Randomized Parallel-Group Trial Using a Decentralized Clinical Trial Platform
Scientific Title:Acronym
Development and Efficacy of Smartphone-Based Psychotherapy for Post-Mastectomy Pain Syndrome: A Multicenter, Sham-Controlled, Double-Blind, Randomized Parallel-Group Trial Using a Decentralized Clinical Trial Platform
Region
| Japan |
Condition
Condition
Post Mastectomy Pain Syndrome
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled trial will be conducted to evaluate the effectiveness of a smartphone application-based psychotherapy for Post Mastectomy Pain Syndrome (PMPS). In addition, this study aims to develop the foundation for a fully decentralized clinical trial, enabling patients to participate without the need to visit the clinic and allowing for remote collection of patient-reported outcomes. Initially, a small-scale pilot trial will be conducted to assess preliminary efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain Interference: Brief Pain Inventory(BPI)
Key secondary outcomes
Pain intensity: Brief Pain Inventory(BPI)
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 and depression: Hospital Anxiety and Depression Scale(HADS)
Psychological flexibility: Acceptance and Action Questionnaire 2(AAQ-2)
Values-based action: 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
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
smartphone-based psychotherapy + usual care
Interventions/Control_2
sham app group + usual care
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. Diagnosed with breast cancer
2. More than one year post-breast cancer surgery with no recurrence
3. Aged 18 years or older at the time of obtaining consent
4. Persistent pain after breast cancer surgery(pain in the surgical site, underarm, or the arm on the operated side) present even one year after surgery, or pain in areas related to reconstructive surgery(such as the reconstructed site, back, or abdomen where surgery was performed for reconstruction) present one year after reconstruction, causing interference with daily life. The average pain intensity and interference with general activity in daily life, as measured by the Brief Pain Inventory(BPI) question 9-A, are 4 points or higher
5. Patients able to install and use the smartphone app on their own on an Android or iOS mobile device(OS version: iOS 15.0 or higher, Android 6.0 or higher) and use it throughout the study period
Key exclusion criteria
1. Patients who are unable to read or write Japanese
2. Patients with pain believed to be caused by factors other than cancer surgery and who are receiving treatment for such pain
3. Patients with pain outside of the surgical site (wound), axilla, or arm, who are receiving treatment for such pain
4. Patients with psychiatric symptoms judged by the principal investigator or sub-investigators to be inappropriate for participation, such as dementia or cognitive impairment, severe depression with suicidal ideation, uncontrolled schizophrenia, or schizoaffective disorder
5. Patients with severe physical illnesses (e.g., severe respiratory diseases, cardiovascular diseases, central or peripheral nervous system disorders, musculoskeletal disorders) for whom psychotherapy is difficult
6. Patients who have previously received the same psychotherapy provided by this app
7. Other patients judged inappropriate for participation by the principal investigator or sub-investigators
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
Department of Psychiatry and Cognitive Behavioral Medicine
Zip code
467-8601
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
090-7042-9321
info@sakura-pj.org
Public contact
Name of contact person
| 1st name | Mie |
| Middle name | |
| Last name | Sakai |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Psychiatry and Cognitive Behavioral Medicine
Zip code
467-8601
Address
Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
090-7042-9321
Homepage URL
info@sakura-pj.org
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
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
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
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 24 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067689
