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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)

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) - Smartphone Acceptance and commitment therapy to Keep mind sUpple for Relief of post mAstectomy pain syndrome in breast cancer patients (SAKURA Project)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051315
Enrollment
40
Registered
2023-06-12
Start date
2023-06-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Eight-week smartphone cognitive-behavioral therapy for post-mastectomy pain syndrome in breast cancer patients Usual treatment group

Sponsors

Nagoya City University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Feasibility

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactMie Sakai

Nagoya City University Graduate School of Medical Sciences Dept. of Psychiatry and cognitive Behavioral Medicine

info@sakura-pj.org090-7042-9321

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026