NCT07101302

iCANSleep: Smartphone App-Based Insomnia Treatment for Cancer Survivors

iCANSleep: A Randomized Controlled Trial of a Smartphone App-Based Insomnia Treatment for Cancer Survivors

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Memorial University of Newfoundland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators will answer the question of whether treating insomnia using the mobile-app-based intervention of Cognitive Behavioural Therapy for Insomnia (CBT-I) for cancer survivors ("iCANSleep") can improve symptoms of insomnia in Canadian cancer survivors compared to a waitlist control group. The investigators will recruit 146 people with insomnia who have completed cancer treatment at least 3 months prior to the study.

Detailed description

The investigators will conduct a randomized controlled trial of immediate treatment with the CBT-I app "iCANSleep" compared to a delayed treatment group with 146 cancer survivors who have completed primary treatment at least 3 months prior and meet DSM diagnostic criteria for insomnia. Participants who are randomized to the immediate treatment group will complete the 7-modules of the CBT-I treatment right away. Those randomized to the delayed treatment group will begin the intervention following an 8-week waiting period. The treatment group will complete assessments at baseline, mid-treatment, post-treatment, and 3-month follow-up. The delayed treatment group will complete an assessment at baseline, halfway through their wait at 4 weeks, and prior to beginning treatment at 8 weeks. They will also complete assessments at mid-treatment, post-treatment and 3-month follow-up. Insomnia severity will be analyzed using the Insomnia Severity Index (ISI) as the primary outcome. Other measures will include fatigue, anxiety, depression, pain, work productivity, sleep beliefs, daytime impact of insomnia, and pre-sleep arousal. The investigators hypothesize that the immediate treatment group will report significantly greater improvements in insomnia compared to the waitlist control group at post-treatment (primary endpoint). The investigators also hypothesize that these improvements will be maintained at 3-months follow-up (secondary endpoint).

Conditions

• Insomnia
• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	App-Based Cognitive Behavioural Therapy for Insomnia	The iCANSleep app is based on an established CBT-I protocol. The core features of the iCANSleep app include 1) a modified CBT-I protocol for cancer survivors and 2) daily sleep diaries. Core components of CBT-I treatment to be implemented include sleep restriction, stimulus control, cognitive restructuring, and psychoeducation. These components will be modified into 7-weekly modules.

Timeline

• Start date: 2025-11-04
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-08-03
• Last updated: 2026-02-20

Locations

1 site across 1 country: Canada