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Smartphone behavioral activation and problem-solving therapy for fear of recurrence among breast cancer patients: A randomized control trial

Smartphone behavioral activation and problem-solving therapy for fear of recurrence among breast cancer patients: A randomized control trial - SMILE project

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031140
Enrollment
444
Registered
2018-03-01
Start date
2018-03-01
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

Intervention group: They start to use the smartphone-based problem-solving treatment program &quot
Kaiketsu-App&quot
for iPhones and iPads and the smartphone-based behavioral activation program the &quot
Genki-App&quot
for iPhones and iPads.&quot
consists of 7 sessions, including one introductory section, 4 sessions for learning PST 5 steps, 1 session for actual training, and one epilogue. The &quot
can be completed within 4 weeks at the fastest. One session needs approximately 30 minutes to complete. &quot
has been developed as a part of the smartphone-based CBT program &quot
Kokoro-App&quot
that was developed for our previous study.&quot
consists of 2 sessions.The &quot
can be completed within between 2 weeks and 8 weeks and each session needs approximately 30 minutes per week to complete. Waiting list control group: If the participant is allocated to the control gr

Sponsors

Japan Supportive, Palliative and Psychosocial Oncology Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) diagnosis of breast cancer and awareness of the cancer diagnosis 2) 1 year after breast surgery 3) currently disease-free 4) able to complete e-patient reported outcome (ePRO) by using iPhone 5) iPhone and/or iPad user and having apple ID to install application on Apple store

Exclusion criteria

Exclusion criteria: 1) Having active and serious physical disease that disturb household and light work and current and past history of cancer other than breast cancer 2) Having serious psychiatric disease 3) an inability to understand Japanese 4) currently following up and getting treated in a psychiatry department and/or by any other mental health professionals 5) inappropriate to participate judged by researchers 6) patients who received structured problem-solving therapy, behavioral action therapy, and cognitive-behavioral therapy including participants into our previous study investigating the preliminary effectiveness of the smartphone-based problem-solving treatment

Design outcomes

Primary

MeasureTime frame
Fear of recurrence: Japanese version of the Concerns About Recurrence Scale (CARS-J)

Secondary

MeasureTime frame
1.Fear of recurrence: Fear of Cancer Recurrence Inventory short form (FCRI-SF-J) 2. Psychological distress: Hospital Anxiety and Depression Scale (HADS) 3. Patients perceived needs: Short-form Supportive Care Needs Survey questionnaire (SCNS-SF34) 4. Posttraumatic Growth Inventory-Japanese (PTGI-J) 5. Level of satisfaction with treatment

Countries

Japan

Contacts

Public ContactTatsuo Akechi

Nagoya City University Graduate School of Medical Sciences Department of Psychiatry and Cognitive-Behavioral Medicine

takechi@med.nagoya-cu.ac.jp052-853-8271

Outcome results

None listed

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