Condition category
Mental and Behavioural Disorders
Date applied
30/01/2020
Date assigned
13/02/2020
Last edited
11/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cancer not only creates physical problems but can also cause psychological problems, including sleep-related problems. Sleep-related problems, including insomnia, are known to be effectively treated using cognitive-behavioral therapy (CBT). However, CBT is expensive in terms of space, time, and monetarily. Therefore, in this study, a CBT mobile application was developed, and the aim of this study is to find out whether the developed mobile application is effective in reducing sleep-related problems in cancer patients.

Who can participate?
Those aged 16-65 years with a past diagnosis of any type of cancer may participate.

What does the study involve?
The study involves filling out a few questionnaires, and doing a simple 10-minute computer task. After this step, the participant will be randomly placed in a group which either uses or does not use a mobile application. In the group that uses a mobile application, CBT methods will be taught everyday for 10-15 minutes on weekdays for 66 days. After 66 days for all groups, the questionnaires and computer task that was previously done will be completed again, after which participation is ended.

What are the possible benefits and risks of participating?
Benefits of the study are that participants, regardless of which group they are placed in, will have access (at the end of the study for some groups) to the CBT application which may help them reduce their sleep-problems. Risks include fatigue from using mobile phones, or having to access the application everyday.

Where is the study run from?
Yonsei University (South Korea)

When is the study starting and how long is it expected to run for?
April 2016 to April 2019

Who is funding the study?
National R&D Program for Cancer Control, Ministry of Health and Welfare, Republic of Korea (HA16C0021)

Who is the main contact?
Yung Jae Suh
yjsuh1221@yonsei.ac.kr

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Yung Jae Suh

ORCID ID

http://orcid.org/0000-0003-4675-4177

Contact details

10-211ho
Yu Eok-Gyeom Memorial Hall
Yonsei University
50 Yonsei-ro
Seodaemun-gu
Seoul
120-749
Korea
South
+82 02-2123-7536
yjsuh1221@yonsei.ac.kr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRB No. 7001988-315 201901-SB-153-17

Study information

Scientific title

A pilot randomized controlled trial on an app-based cognitive behavioral therapy program for sleep problems in cancer patients

Acronym

Study hypothesis

The intervention group that used an app-based CBT program will have less sleep-related symptoms compared to a control group that did not use an app-based CBT program.

Ethics approval

Approved 17/12/2019, Yonsei University Institutional Review Board (), ref: IRB NO. IRB No. 7001988-315 201901-SB-153-17

Study design

Multi-centered interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sleep-problems in cancer patients

Intervention

All participants went through the following steps: screening, pre-intervention assessment, intervention in the intervention or attention control group or waiting in the waitlist control group, and post-intervention assessment.

The participants who met the inclusion criteria were randomly assigned to the three groups (HARUToday Sleep, HARUCard Sleep, and waitlist control group). Each participant drew a card from a shuffled deck of three cards, one for each group, and was assigned into the drawn group. Participants were blinded about which treatment they were receiving and what type of groups were being compared in the study.

HARUToday Sleep:
The participants installed the HARUToday Sleep program on their personal smartphones after the pre-intervention assessment and were instructed to complete one session per day for a total of 10 weeks (66 days) at home, excluding weekends.
The HARUToday Sleep program is composed of five cognitive behavioral therapy zones and 48 sessions, each of which takes approximately 10 to 15 minutes to complete. All sessions are composed of four phases: 1) Sleep quality rating, 2) Lesson, 3) Summary, and 4) Quizzes. In the “Sleep quality rating” phase, participants rate their sleep quality from 0 points to 10 points, after which there was a “Lesson” phase, “Summary” phase, and “Quiz” phase. Other features included reward and prompting systems.

HARUCard Sleep:
The HARUCard Sleep program was developed for the attention control group. This group was added in order to control, at least partially, the confounding factor of viewing and paying attention to a mobile application during the training period. Participants in this group received cancer-related information or information on how to manage sleep problems for 66 days, for one session a day, excluding weekends. The sleep quality ratings, as well as the reward and prompting system, were the same as in the HARUToday program.

Participants in all groups completed the same pre-intervention assessment package, which included two questionnaires and a dot-probe computer task.

Trained research assistants administered both the questionnaires and the computer task. All assessments were carried out in laboratory spaces within the present institution or in empty spaces within hospitals.

All participants from the three groups returned to the research lab or the hospital within two weeks of completing the program for the post-intervention and completed the satisfaction survey and post-intervention assessment.

All participants who completed the post-intervention assessment received a monetary reward, and those who were in the attention control or waitlist control group were provided with the HARUToday Sleep app upon request.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Sleep quality measured using the Pittsburgh Sleep Quality Index score at baseline, and after the intervention was completed (66 days excluding weekends)

Secondary outcome measures

Measured at baseline, and after the intervention was completed (66 days excluding weekends):
1. Attention bias measured using the attentional bias score
2. General health measured using the Short-Form 36 score
3. Program satisfaction using the program satsfaction questionnaire

Overall trial start date

30/04/2016

Overall trial end date

30/04/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All genders
2. Age range of 16-65 years
3. Has a past diagnosis of any type of cancer
4. 8.5 points or more on the Pittsburgh Sleep Quality Index (PSQI)
4. Taking no medications (such as antidepressants)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

66

Participant exclusion criteria

Taking sleep-related medication

Recruitment start date

01/06/2018

Recruitment end date

28/02/2019

Locations

Countries of recruitment

Korea, South

Trial participating centre

Yonsei University
50 Yonsei-ro Seodaemun-gu
Seoul
03722
Korea, South

Sponsor information

Organisation

Yonsei University

Sponsor details

Yonsei University International Review Board
50 Yonsei-ro Seodaemun-gu
Seoul
03722
Korea
South
+82 (0)221235143
irb@yonsei.ac.kr

Sponsor type

University/education

Website

https://irb.yonsei.ac.kr/

Funders

Funder type

Government

Funder name

Ministry of Health and Welfare

Alternative name(s)

Ministry of Health, Welfare and Family Affairs, MOHW

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Korea, South

Results and Publications

Publication and dissemination plan

A paper describing the results of the study will be published in 2020, and the application is currently being freely disseminated on mobile application stores.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

01/03/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/02/2020: Trial’s existence confirmed by Yonsei University Institutional Review Board