Sleep Coach: A Mobile App to Address Insomnia Symptoms Among Cancer Survivors

NCT ID: NCT04827459

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-12
• Study Completion Date: 2022-08-08

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.

Conditions

Insomnia; Breast Cancer; Prostate Cancer; Colon Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MI Sleep Coach Mobile Application

The Sleep Coach app includes evidence-based CBT-I strategies, interactive activities and a computerized dialogue agent to engage users in the adoption of and adherence to CBT-I strategies.

Group Type: EXPERIMENTAL

Sleep Coach App

Intervention Type: BEHAVIORAL

Participants will be encouraged to interact with the mobile app daily for as much time as they wish, or for as little as 5 - 10 minutes, over a 7-week period.

Interventions

Sleep Coach App

Participants will be encouraged to interact with the mobile app daily for as much time as they wish, or for as little as 5 - 10 minutes, over a 7-week period.

Intervention Type: BEHAVIORAL

Other Intervention Names

MI Sleep Coach

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Breast Cancer Research Foundation

OTHER

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noel Arring, DNP, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

References

Arring N, Barton DL, Lafferty C, Cox B, Conroy DA, An L. Mi Sleep Coach Mobile App to Address Insomnia Symptoms Among Cancer Survivors: Single-Arm Feasibility Study. JMIR Form Res. 2024 Apr 26;8:e55402. doi: 10.2196/55402.

Reference Type: DERIVED

PMID: 38669678 (View on PubMed)

Other Identifiers

HUM00194610

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2021.004

Identifier Type: -

Identifier Source: org_study_id