Feasibility of a Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers
NCT ID: NCT06889571
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2025-05-12
2025-07-23
Brief Summary
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Main Questions
1. Feasibility:
Can the intervention be successfully implemented in terms of recruitment, retention, adherence to the intervention protocol, safety, and participant satisfaction?
2. Preliminary Effects:
Does the intervention improve subjective sleep outcomes (e.g., insomnia severity, sleep quality, total sleep time, time in bed, sleep efficiency, wake after sleep onset, and sleep onset latency) as well as depressive symptoms, anxiety symptoms, fatigue, caregiver burden, and health-related quality of life?
What Participants Will Do i) Use a 6-week self-help CBT-I program delivered via a WeChat mini program. ii) Receive weekly nurse support sessions (up to 20 minutes each) for six weeks.
* These sessions may be conducted via phone calls or instant messaging, based on participant preference.
* Each session includes reviewing weekly progress, addressing any barriers to adherence, and planning next steps.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers
Nurse-Supported Mobile App for Self-Help CBT-I
The intervention consists of two components: 1) a mobile app delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session.
Interventions
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Nurse-Supported Mobile App for Self-Help CBT-I
The intervention consists of two components: 1) a mobile app delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session.
Eligibility Criteria
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Inclusion Criteria
* Informal caregiver (e.g., family members, friends, or neighbors) who co-resides with and provides unpaid care for cancer survivors of any site or stage, with daily contact of at least 4 hours. If two or more caregivers are available for a cancer survivor, the one providing most of the daily care will be included.
* Able to understand the research procedures, and read and communicate in Chinese
* Able to use WeChat
* Insomnia severity index scores \> 7
Exclusion Criteria
* Psychotic disorders (e.g., bipolar disorder, schizophrenia); Suicidal ideation with intent and plan OR attempted suicide within the past 2 months
* Currently taking any psychotropic drugs (e.g., antidepressants, anxiolytics, sleep medications)
* Unstable or acute medical condition or condition requiring surgery in the next 6 months; Pregnancy; or Epilepsy
* Currently participating in any other interventional program
* Prior experience with CBT-I
* Night, evening, early morning or rotating shift work
* Currently caring for a cancer patient receiving hospice care
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Yangxi Huang
Principal Investigator
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Other Identifiers
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Nurse-supported CBT-I 2025
Identifier Type: -
Identifier Source: org_study_id
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