Smartphone-based distress screening, information provision, and psychotherapy for reducing psychological distress among AYA cancer survivors: protocol for a fully decentralized muti-center randomized controlled clinical trial

UMIN ID: UMIN000054583

Registered date:06/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: cancer
• Date of first enrollment: 2024/05/13
• Target sample size: 224
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Distress screening-based information provision Participants' distress and supportive care needs will be screened by smartphone-based Japanese version of the Distress Thermometer and Problem List (DTPL-J) at week 0 and 4. DTPL-J consist of 49 items including 5 categories (physical problems, Family problems, Practical problems, Emotional problem, and Spiritual or Religious problems) and its validity and reliability was confirmed. Based on the screening, the participants will be automatically directed to the website of a public medical institution that provides appropriate information and self-care skills that help to ameliorate its distress and needs. If there will no appropriate website, the multidisciplinary research teams compensate for these information.
Smartphone-based Problem solving therapy (PST) PST provides patients with a structured, five-step strategy for solving their problems: (1) identification, definition, and breakdown of the problem; (2) establishing achievable goals; (3) generating solutions; (4) evaluating and choosing the solution; and (5) implementing the chosen solution and evaluating the outcome after implementation. The smartphone-based PST program (Life2Bits Inc., Japan) was developed for this study. The app development was based on our empirically supported PST manual. The app comprise nine sessions. Each session takes approximately 10 minutes to complete.

Outcome(s)

• Primary Outcome: Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF)
• Secondary Outcome: Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), UCLA Loneliness Scale version 3 Japanese version short form (UCLA-LS3-J-SF), Brief Resilience Scale Japanese version (BRS-J), Euro QOL 5D-5L (EQ-5D-5L)

Key inclusion & exclusion criteria

• Age minimum: 15years-old
• Age maximum: 39years-old
• Gender: Male and Female
• Exclude criteria: (1) Estimated prognosis is within 6 months. (2) Currently attending psychiatry or psychosomatic medicine. (Follow-up by the palliative care team is acceptable.) (3) Patients with psychiatric symptoms that the physician deems inappropriate for participation, such as dementia, cognitive dysfunction, or severe depression with thoughts of death. (4) Difficulty in reading and writing Japanese. (5) Have participated in cognitive-behavioral therapy, including smartphone-based therapy (e.g., our previous studies; Smile Project, Smile Again Project, or Sakura Project). (6) The investigator determines that the patient is not suitable to participate in the study.

Related Information

• Primary Sponsor: Nagoya City University
• Source(s) of Monetary Support: Japan science and technology agency