Clinical Trial: 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 (Japan)

Tokyo, Sept. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059180) titled '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' on Sept. 24.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Nagoya City University

Condition: Condition - Post Mastectomy Pain Syndrome Classification by malignancy - Malignancy Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - smartphone-based psychotherapy + usual care Interventions/Control_2 - sham app group + usual care

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 Size - 40

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067689

Disclaimer: Curated by HT Syndication.