Condition category
Mental and Behavioural Disorders
Date applied
29/03/2018
Date assigned
19/04/2018
Last edited
08/10/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Thanks to medical and technological advancements, most children diagnosed with cancer survive their disease. But, what happens after cancer treatment has finished? The cancer has not only affected the child but the whole family in various ways. For parents, a child’s treatment completion is not only an important milestone but also a period of emotional vulnerability. Some parents reports negative long-term emotional consequences years after their child’s treatment is completed. In spite of this, there is an unmet need of psychological support in the healthcare sector for those parents experiencing low mood after their child’s cancer treatment ended.
A potential solution to address this unmet need is to deliver psychological support via the internet. This may increase access to psychological support and may be an effective and acceptable alternative to standard methods of psychological care.
The goal is to examine the feasibility and acceptability of the internet-administered, cognitive-behavioral therapy based, guided, self-help programme - ENGAGE - for parents of children previously treated for cancer. We will also examine the feasibility and acceptability of the study design to help inform future studies in this area. The study’s findings represent a first step to providing parents of children previously treated for cancer with the care that they need.

Who can participate?
Mother and fathers who are feeling distressed or low after their child’s completed cancer treatment, to an extent were they feel a need of psychological support. Parents will live in Sweden, and will be able to write and read in Swedish. The child will have been no older than 18 years old when diagnosed with cancer. Parents also need to have access to email, the internet, and a mobile phone and Bank ID to log onto the internet-administered programme.

What does the study involve?
All eligible parents will be offered the opportunity to access the ENGAGE internet-administered programme. ENGAGE is a therapist-guided self-help programme delivered via the internet that was developed in close collaboration with parents. The programme is based on cognitive-behavioral therapy – an evidence based psychological approach. The programme lasts for 10 weeks and parents will receive guidance from an e-therapist on a weekly basis. The programme starts with one introduction module followed by up to 10 other modules that address specific concerns reported by parents of children previously treated for cancer. Parents will answer questionnaires at three different times: before and after treatment, and at six-months after the treatment has ended.

What are the possible benefits and risks of participating?
We hope that parents who take part in the study will benefit from the ENGAGE programme. Working with the ENGAGE programme may lead to improvements in psychological distress, for example low mood and anxiety. We also hope that participation in the ENGAGE programme and study will not cause any parents harm. When receiving support from an e-therapist, parents may be asked personal questions that they might find difficult to answer, or distressing. The e-therapists are trained to manage distress in a supportive and understanding manner and parents do not need to answer any questions they do not wish to. Parents will also be asked questions about their mood at three different time during the study. Some of these questions will be personal in nature and parents may find them hard to answer, or distressing. Again, parents don’t have to answer these questions if they do not want to. Also, if at any time during the study parents report levels of distress that require more intensive support, we will ensure parents will be referred to more appropriate support for their needs.

Where is the study run from?
Uppsala University (Sweden)

When is study starting and how long is it expected to run for?
March 2014 to January 2020.

Who is funding the study?
1. Vetenskapsrådet (Sweden)
2. Barncancerfonden (Sweden)
3. Cancerfonden (Sweden)

Who is the main contact?
1. Professor Louise von Essen (scientific)
louise-von.essen@kbh.uu.se
2. Dr Joanne Woodford (scientific)
joanne.woodford@kbh.uu.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Louise von Essen

ORCID ID

http://orcid.org/0000-0001-5816-7231

Contact details

MTC-house
Akademiska sjukhuset
Uppsala
75185
Sweden

Type

Scientific

Additional contact

Dr Joanne Woodford

ORCID ID

http://orcid.org/0000-0001-5062-6798

Contact details

MTC-house
Akademiska sjukhuset
Uppsala
75185
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

A feasibility study of an internet-administered, guided, CBT-based, self-help intervention (ENGAGE) for parents of children previously treated for cancer

Acronym

ENGAGE

Study hypothesis

The aim is to examine the feasibility and acceptability of the internet-administered, cognitive behavioral therapy (CBT)-based, guided, self-help intervention ENGAGE for parents of children previously treated for cancer and the study procedures for a future controlled trial. The key feasibility outcomes examined via the proposed protocol concern methodological, procedural, and clinical uncertainties, including:
(1) estimates of likely recruitment and retention rates
(2) feasibility and acceptability of data collection instruments and data collection procedures
(3) feasibility and acceptability of the intervention.

Ethics approval

The Regional Ethical Review Board in Uppsala, Sweden has granted approval for the study, 14/03/2018. ref: 2017/527

Study design

The study has an uncontrolled, within-group, baseline-, post-treatment (12 weeks), and six-month follow-up design with an embedded qualitative and quantitative process evaluation.

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Condition

Posttraumatic stress, depression, anxiety

Intervention

ENGAGE can be described as an internet-administered, guided, cognitive-behavioral therapy (CBT) based, self-help intervention. All participants will receive the intervention. The intervention is guided by an e-therapist for 10 weeks. Guidance will be provide via video or telephone call (initial and mid-treatment support sessions) with additional email support provided each week. The intervention comprises of one introductory chapter followed by up to 10 treatment modules addressing key concerns identified for the population. The intervention is 10 weeks. Participants will be followed-up post-intervention (12 weeks post allocation) and 6 months follow-up.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Recruitment and eligibility is assessed by:
1. Number of parents identified via the Swedish Childhood Cancer Registry and the Swedish Tax Agency and/or via advertisements at the end of the 6 month recruitment period
2. Percentage of parents assessed for eligibility; fulfilling inclusion criteria, and included (of total number identified) at the end of the 6 month recruitment period
3. Ambiguities regarding eligibility criteria throughout the 6 month recruitment period
4. Reasons for ineligibility throughout the 6 month recruitment period
5. Reasons for non-participation throughout the 6 month recruitment period

Data collection is assessed by:
1. Percentage of participants completing questionnaires at baseline, post-treatment (12 weeks) and 6 month follow-up
2. Numbers of missing items on each clinical outcome measurement at baseline, post-treatment (12 weeks) and 6 month follow-up
3. Types and number of potential uncertainties in diagnostic interviews at baseline

Attrition is assessed by:
1. Rates of study dropout at post-treatment (12 weeks) and 6 month follow-up
2. Rate of intervention dropout at post-treatment (12 weeks)

Resources needed to complete the study and the intervention is assessed by:
Length of time required for:
1. participants to work through the intervention at post-treatment (12 weeks)
2. participants to complete questionnaires and interviews at baseline, post-treatment (12 weeks) and 6 month follow-up
3. e-therapists to deliver the intervention at post-treatment (12 weeks)
4. study personnel to administer the study, assessed at the end of the feasibility trial

Participants’ adherence to intervention is assessed by:
Number of:
1. opened introductory chapters at post-treatment (12 weeks)
2. opened CBT modules, completed action plans at post-treatment (12 weeks)
3. completed video or telephone assessment sessions at post-treatment (12 weeks)
4. completed ‘booster’ support sessions at post-treatment (12 weeks)

Participants’ use of the intervention is assessed by:
Number of:
1. logins at post-treatment (12 weeks)
2. use of optional support functions at post-treatment (12 weeks)

E-therapists’ adherence to intervention is assessed by:
1. Content of internet-administered written e-therapist-parent communication at post-treatment (12 weeks)

Participants’ acceptability of intervention and data
1. Reasons for poor attendance and withdrawal from study and intervention at post-treatment (12 weeks) and 6 month follow-up
2. Impressions and experiences of working with the intervention (including positive and negative consequences) and of completing questionnaires and interviews at post-treatment (12 weeks)

Secondary outcome measures

1. Symptoms of post-traumatic stress (PTSS) is measured using the revised Post traumatic Stress Disorder Checklist for DSM-5 (PCL-5) and DSM-IV (PCL-C) at baseline, weekly, post-treatment (12 weeks) and 6 month follow-up.
2. Symptoms of depression is measured using the Patient Health Questionnaire (PHQ-9) at baseline, post-treatment (12 weeks) and 6 month follow-up.
3.Symptoms of anxiety is measured using GAD-7 at baseline, weekly, post-treatment (12 weeks) and 6 month follow-up.
4. Frequency of parental fear of cancer recurrence and of their child experiencing another serious health condition is measured using 5 item Likert scales developed by the research team and rated from ”very often” to ”not at all” at baseline, post-treatment (12 weeks) and 6 month follow-up.
5. Psychological inflexibility and experiential avoidance is measured using the Acceptance and Action Questionnaire, 6-items (AAQ-6) at baseline, weekly, post-treatment (12 weeks) and 6 month follow-up.
6. Depressive inactivity is measured using the Behavioural Activation for Depression Scale (BADS) at baseline, weekly, post-treatment (12 weeks) and 6 month follow-up.
7. Symptoms of fatigue is measured using the Fatigue Severity Scale (FSS) at baseline, post-treatment (12 weeks) and 6 month follow-up.
8. Self-compassion is measured using the Self-Compassion Scale-Short form (SCS-SF) at baseline, post-treatment (12 weeks) and 6 month follow-up.
9. Quality of life is measured using the EQ-5D and with a modified short-version of the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TiC-P), assessing direct and indirect medical costs and indirect non-medical costs at baseline, post-treatment (12 weeks) and 6 month follow-up.
10. Psychiatric disorders is measured using the M.I.N.I neuropsychiatric interview at eligibility interview, post-treatment (12 weeks) and 6 month follow-up

Overall trial start date

01/03/2014

Overall trial end date

31/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Parents/caregivers (adults, both mothers and fathers) will be included according to:
1. Parent of a child diagnosed with cancer when 0-18 years who has completed cancer treatment three months to five years previously
2. Resides in Sweden
3. Able to read and understand text in Swedish
4. Has access to e-mail, the internet, and a mobile telephone and/or Bank ID
5. Self-reports a need for psychological support related to the child’s cancer disease and treatment

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

The following exclusion criteria will be used:
1. Self-reported or clinician assessed (based on the M.I.N.I neuropsychiatric interview) symptoms of a severe and enduring mental health difficulty
2. Self-reported or clinician assessed (based on the M.I.N.I neuropsychiatric interview) misuse of alcohol, street drugs, and/or prescription medication
3. Acutely suicidal
4. Currently attending psychological treatment. Those excluded due to a severe and enduring mental health difficulty, substance misuse, and/or acute suicidality will be guided to appropriate healthcare services.

Recruitment start date

01/05/2019

Recruitment end date

31/10/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Clinical Psychology in Healthcare, Department of Women's and Children's Health, Uppsala University
MTC-house, Akademiska sjukhuset
Uppsala
75185
Sweden

Sponsor information

Organisation

Uppsala University

Sponsor details

Box 256
Uppsala
751 05
Sweden

Sponsor type

University/education

Website

http://www.uu.se/

Funders

Funder type

Not defined

Funder name

Vetenskapsrådet

Alternative name(s)

Swedish Research Council, VR

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

Sweden

Funder name

Cancerfonden

Alternative name(s)

Swedish Cancer Society

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Funder name

Barncancerfonden

Alternative name(s)

Swedish Childhood Cancer Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Sweden

Results and Publications

Publication and dissemination plan

The ENGAGE protocol is prepared and planned to be submitted to an open access journal in Spring 2018 ( June 2018). Results from the ENGAGE study will be submitted to open access journals in the beginning of 2020.
The results we plan to present are:
1. Intervention feasibility results
2. Intervention adherence/internet-administered CBT usage

IPD sharing statement:
At present, Swedish Universities are working towards the finalisation of mechanisms to share research data in accordance with General Data Protection Regulation (GDPR), as such the exact criterion cannot yet be specified concerning for how long data will be available, exact data sharing mechanisms and how participant consent will be obtained and any additional ethical or legal restrictions. Once data sharing mechanisms have been put in place, in accordance with GDPR, we will be able to provide further details concerning data sharing

Intention to publish date

31/01/2020

Participant level data

Other

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29903802

Publication citations

Additional files

Editorial Notes

08/10/2018: The following changes were made to the trial record: 1. The contacts were updated. 2. The recruitment start date was changed from 01/09/2018 to 01/05/2019. 3. The recruitment end date was changed from 31/03/2019 to 31/10/2019. 13/07/2018: Publication reference added.