Feasibility of a Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers

NCT06889571 | Completed

• 1 other identifier: Nurse-supported CBT-I 2025
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

• 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.

Conditions

Insomnia; Cancer Caregivers

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  The recruitment rate will be evaluated by the percentage of the target number of participants successfully recruited per month.

  Every month, up to 1 year

• Retention rate

  The retention rate will be assessed by the percentage of recruited participants providing outcome data at post-intervention time point.

  Post-intervention (i.e., at the end of the 6-week intervention period)

• Adherence rate

  The adherence rate will be measured by the percentage of recruited participants who adhere to the proposed intervention, including reviewing sessions on the WeChat mini program and engaging in weekly nurse support sessions.

  Post-intervention (i.e., at the end of the 6-week intervention period)

• Participants' perspectives of acceptability and satisfaction

  The participants' perspectives of acceptability and satisfaction will be evaluated using eight adapted items from the Acceptability E-scale. Each item is rated on a 5-point Likert scale, with scores ranging from 1 to 5. The total score ranges from 8 to 40, with higher scores indicating greater acceptability and satisfaction with the intervention.

  Post-intervention (i.e., at the end of the 6-week intervention period)

• Adverse events

  All adverse events reported by the participants will be documented.

  Throughout the study period (from baseline to post-intervention [i.e., at the end of the 6-week intervention period])

• Participants' perceived experiences of the proposed intervention

  Participants' perceived experiences of the proposed intervention (e.g., intervention delivery, adherence, safety, and satisfaction) will be assessed through post-intervention qualitative interviews to provide a further understanding of the intervention's feasibility.

  Post-intervention (i.e., at the end of the 6-week intervention period)

Secondary Outcomes (8)

• Insomnia severity

  T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period）

• Sleep patterns

  T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)

• Sleep quality

  T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)

• Caregiver burden

  T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)

• Depressive symptoms

  T0 (Baseline): prior to the start of the intervention, T1 (6 weeks): Post-intervention (i.e., at the end of the 6-week intervention period)

Study Arms (1)

Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers

EXPERIMENTAL

Behavioral: Nurse-Supported Mobile App for Self-Help CBT-I

Interventions

Nurse-Supported Mobile App for Self-Help CBT-I BEHAVIORAL

The intervention consists of two components: 1) a mobile app delivered 6-week self-help CBT-I program; and 2) Weekly nurse support session.

Nurse-Supported Mobile App for Self-Help CBT-I in Cancer Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 21, 2025
• Study Start: May 12, 2025
• Primary Completion: July 20, 2025
• Study Completion: July 23, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Locations

CN (1)