Post Mastectomy Pain Syndrome
Conditions
Interventions
smartphone-based psychotherapy + usual care
sham app group + usual care
Sponsors
Nagoya City University
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Interference: Brief Pain Inventory(BPI) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactMie Sakai
Nagoya City University Graduate School of Medical Sciences Department of Psychiatry and Cognitive Behavioral Medicine
Outcome results
None listed