Clinical trial NCT06889571: Feasibility of a Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers
Official title: A Single-arm Feasibility Study of Nurse-supported Mobile App for Self-help CBT-I in Cancer Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Cancer Caregivers
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study Goal The goal of this clinical trial is to evaluate whether a nurse-supported mobile app for self-help cognitive behavioral therapy for insomnia (CBT-I) is feasible for cancer caregivers and whether it can improve their sleep-related outcomes and overall well-being.

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.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* 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:

* Another sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome, rapid eye movement behavior disorder), besides insomnia, that is not adequately treated
* 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Every month, up to 1 year
measure: Retention rate
timeFrame: 6 weeks after randomization
measure: Adherence rate
timeFrame: 6 weeks after randomization
measure: Participants' perspectives of acceptability and satisfaction
timeFrame: 6 weeks after randomization
measure: Adverse events
timeFrame: Throughout the study period (from baseline to 6 weeks post-randomization)
measure: Participants' perceived experiences of the proposed intervention
timeFrame: 6 weeks post-randomization
Secondary outcomes:
measure: Insomnia severity
timeFrame: T0 (Baseline): prior to randomization, T1 (6 weeks): 6 weeks after randomization
measure: Sleep patterns
timeFrame: T0 (Baseline): prior to randomization, T1 (6 weeks): 6 weeks after randomization
measure: Sleep quality
timeFrame: T0 (Baseline): prior to randomization, T1 (6 weeks): 6 weeks after randomization
measure: Caregiver burden
timeFrame: T0 (Baseline): prior to randomization, T1 (6 weeks): 6 weeks after randomization
measure: Depressive symptoms
timeFrame: T0 (Baseline): prior to randomization, T1 (6 weeks): 6 weeks after randomization
measure: Anxiety symptoms
timeFrame: T0 (Baseline): prior to randomization, T1 (6 weeks): 6 weeks after randomization
measure: Fatigue
timeFrame: T0 (Baseline): prior to randomization, T1 (6 weeks): 6 weeks after randomization
measure: Health-related quality of life
timeFrame: T0 (Baseline): prior to randomization, T1 (6 weeks): 6 weeks after randomization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: