iCANSleep: Smartphone App-Based Insomnia Treatment for Cancer Survivors

Memorial University of Newfoundland

Status: Not yet enrolling

Conditions: Insomnia; Cancer

Treatments: Behavioral: App-Based Cognitive Behavioural Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT07101302

43146

Details and patient eligibility

About

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.

Full 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).

Enrollment: 146 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cancer survivors
• Over 18 years of age
• Lives in Canada
• Understands English or French fluently
• DSM-5 diagnosis of insomnia
• ISI score of 8 or higher
• Good performance status as indicated by a score of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
• Access to internet connection
• Ownership of smartphone
• Fluency using mobile applications.
• Individuals with non-hematological malignancies must show no evidence of cancer or clinically stable/inactive disease for a minimum of 3 months prior to enrollment (for individuals with non-metastatic cancer) or be on a stable treatment regimen for the prior 3 months (for individuals with metastatic cancer) to ensure that insomnia is not a direct, acute response to cancer treatment.
• Individuals with hematological malignancies must be in remission at the time of recruitment and have completed cancer treatments (e.g., transplant, chemotherapy, immunotherapy, radiotherapy) at least 3 months prior.

Exclusion criteria

• 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.
• The use of medications prescribed for sleep (e.g., hypnotics, sedatives, or antidepressants) will be tracked and adjusted for in the statistical analysis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Immediate Treatment

Experimental group

Description:

The immediate treatment group will begin the app-based insomnia intervention immediately after enrolling.

Treatment:

Behavioral: App-Based Cognitive Behavioural Therapy for Insomnia

Waitlist Control

Experimental group

Description:

The waitlist control group will begin the app-based intervention after a waiting period of 8 weeks after enrolling.

Treatment:

Behavioral: App-Based Cognitive Behavioural Therapy for Insomnia