Health TrialsbyHealthPanel

iCANSleep: Smartphone App-Based Insomnia Treatment for Cancer Survivors

ConditionsInsomniaCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial University of Newfoundland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cancer survivors

Over 18 years of age

Lives in Canada

Understands English or French fluently

Disqualifiers

Presence of a sleep disorder other than insomnia that is not adequately treated (e.g., untreated sleep apnea)

Presence of a psychological disorder that is currently untreated or would impair the ability to participate (e.g., bipolar disorder)

Major sensory deficit (e.g., blindness)

Previous experience receiving CBT-I.

Trial design

Design model

Single group

Treatments tested in this trial

  • App-Based Cognitive Behavioural Therapy for Insomnia

    Behavioral

    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.

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: Immediate TreatmentExperimental treatment 1 intervention
Group B: Waitlist ControlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Insomnia Severity

Insomnia Severity Index (Min: 0, Max: 28; Higher scores = worse outcomes)

Time frame
From enrollment until 3-month follow-up
2

Sleep Efficiency

Sleep efficiency measured by the Consensus Sleep Diary

Time frame
From enrollment to end of treatment at 7 weeks
3

Sleep-Onset Latency

Sleep-onset latency measured by the Consensus Sleep Diary

Time frame
From enrollment to end of treatment at 7 weeks
4

Wake After Sleep Onset

Wake after sleep onset measured by the Consensus Sleep Diary

Time frame
From enrollment to end of treatment at 7 weeks

Secondary outcomes

1

Fatigue

Patient-Reported Outcome Measurement Information System: Fatigue 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

Time frame
From enrollment to 3-month follow-up
2

Anxiety

Patient-Reported Outcome Measurement Information System Anxiety 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

Time frame
From enrollment to 3-month follow-up
3

Depression

Patient-Reported Outcome Measurement Information System Depression 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

Time frame
From enrollment to 3-month follow-up
4

Pain Level

Patient-Reported Outcome Measurement Information System Pain 8a Short Form (Min: 8, Max: 40; Higher scores = worse outcomes)

Time frame
From enrollment to 3-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial University of Newfoundland

Lead sponsor

Source ClinicalTrials.gov
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