Clinical trial NCT04827459: Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
Official title: Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Breast Cancer
Prostate Cancer
Colon Cancer
Keywords: cancer survivor
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
Collaborators: name: Breast Cancer Research Foundation
First posted: 2021-04-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial will evaluate the adherence, usefulness, satisfaction and effect size for the Sleep Coach app as an intervention for insomnia in 30 adult post-treatment cancer survivors.

Detailed description: Difficulty sleeping, falling and/or staying asleep, is common in people after they have been diagnosed and treated for cancer. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered to be the preferred treatment but until now, there has been limited access for most people to CBT-I because it has required an in-person visit with a trained therapist. This research study is to test a mobile CBT-I app called MI Sleep Coach to deliver CBT-I. The goal of this study is to understand if people are willing to use the app, if they find it useful in helping with sleep difficulty and if they are satisfied with using it. The investigators hope to use information from this small feasibility study to study the effectiveness of the app in a larger group of cancer survivors and ultimately to help cancer survivors with sleep difficulties to sleep better.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Has completed curative-intent treatment (chemo, surgery, RT) for prostate, colon or breast cancer at least three months and not more than 5 years prior to study entry. Note: Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex), Herceptin and maintenance therapies are allowed.
* Ability to read and write English
* Ability to complete questionnaire(s) by themselves or with assistance.
* Reports trouble falling asleep or staying asleep on at least 3 nights per week (most weeks) for the last 3 months.
* Own an Android phone version 8 or higher (The latest version of Android is 11.0) or an iPhone running iOS 11 or higher (The latest version of iOS is 14.3.)
* Ability to provide informed written consent.

Exclusion Criteria:

* Inability to read and write English
* Diagnosis of a sleep disorder other than insomnia (e.g. sleep apnea, restless legs syndrome, narcolepsy)
* Diagnosis of Insomnia prior to cancer diagnosis
* Reports physical symptoms that interfere with sleep, such as shortness of breath, pain, hot flashes, frequent urination
* Major psychiatric or medical condition other than cancer suspected to contribute to their sleep disturbance
* Evidence of active cancer (i.e. not considered NED)
* Currently or previously received CBT-I
* Patients who are night shift workers or subject to other external restrictions on their opportunity to sleep at night.

Primary outcomes:
measure: Percentage of participants engaging with the app at least 4 days/week
timeFrame: 7 weeks
measure: Percentage of participants that find the intervention useful
timeFrame: 7 weeks
measure: Percentage of participants satisfied with the intervention
timeFrame: 7 weeks
Secondary outcomes:
measure: Effect size of the intervention as measured by the Insomnia Severity Index (ISI).
timeFrame: baseline to 7 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Noel Arring, DNP, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: