Mobile app for helping cancer caregivers with insomnia
A Single-arm Feasibility Study of Nurse-supported Mobile App for Self-help CBT-I in Cancer Caregivers
This study is testing a mobile app with nurse support to help cancer caregivers improve their sleep and overall well-being over six weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06889571 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility of a nurse-supported mobile app designed for self-help cognitive behavioral therapy for insomnia (CBT-I) specifically for cancer caregivers. Participants will engage in a 6-week program delivered through a WeChat mini program, complemented by weekly nurse support sessions. The study aims to assess recruitment, retention, adherence, safety, and participant satisfaction, as well as the preliminary effects on sleep-related outcomes and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are informal caregivers aged 18 and older who provide daily care for cancer survivors and experience insomnia.
Not a fit: Patients with other untreated sleep disorders or severe psychiatric conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall well-being for cancer caregivers.
How similar studies have performed: While the approach of using mobile apps for CBT-I is gaining traction, this specific application for cancer caregivers is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Yangxi Huang
- Email: hyangxi@connect.hku.hk
- Phone: +852 6358 1459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.