Condition category
Cancer
Date applied
26/11/2020
Date assigned
07/12/2020
Last edited
07/12/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Survival rates for childhood brain tumours are improving, but quality of life after treatment is the worst of all cancer survivors. Research on psychological treatments after cancer treatment is the top priority for young people who have had cancer. This study aims to find out if a psychological therapy called Acceptance and Commitment Therapy (ACT) delivered remotely via video-conferencing is a feasible and acceptable treatment for young brain tumour survivors. The study also aims to find out how helpful ACT is for young brain tumour survivors’ health and wellbeing.

Who can participate?
Participants aged 11-to-24 years old who have been diagnosed with a brain tumour and completed treatment at least 6-months before starting the study.

What does the study involve?
Participants will have a 50:50 chance of being placed into one of two groups: Half the study participants will be offered up to 12 weekly sessions of ACT straight away and the other half will be offered ACT after a 12-week wait. The effect of ACT straight away will be compared to those waiting. Every 3-months during this 12-week period participants will be asked to fill in some questionnaires about their health and experience of ACT.

What are the possible benefits and risks of participating?
Acceptance and Commitment Therapy is an evidence-based psychological therapy shown to help improve the physical and mental wellbeing among people with long-term health problems. Therefore, it is expected that participants may experience improvements in their health as a result of taking part.

The intervention is expected to reduce not cause distress, but some participants may experience transitory increases in distress during treatment or find it distressing to be asked about emotions in questionnaires. Therefore, treatment procedures include standardised assessment of participant experience of therapy at every session to enable therapists to be responsive to participant distress. Furthermore, all assessment interviews with participants will be carried out by qualified clinical psychologists who are able to manage any distress related to questionnaires.

Where is the study run from?
Nottingham University Hospitals NHS Trust, University Hospitals Bristol NHS Foundation Trust, and Newcastle-Upon-Tyne Hospitals NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
From September 2018 to January 2023

Who is funding the study?
The Brain Tumour Charity (UK)

Who is the main contact?
Dr Sam Malins
Sam.malins@nottingham.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Sam Malins

ORCID ID

http://orcid.org/0000-0001-9570-186X

Contact details

Nottingham University Hospitals NHS Trust
Department of Clinical Psychology and Neuropsychology
Room 1285A
C Floor
West Block
Queen’s Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924 ext. 86165
Sam.malins@nottingham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 47122, IRAS 266746

Study information

Scientific title

Acceptance and commitment therapy for young brain tumour survivors: an acceptability and feasibility trial

Acronym

ACT NOW

Study hypothesis

1. That ACT will be acceptable and feasible as a psychological treatment to improve quality of life among young brain tumour survivors aged 11-24
2. That ACT will be acceptable and feasible when delivered remotely via video-conferencing
3. That ACT will be clinically effective in improving secondary health and functioning outcomes

Ethics approval

Approved 24/11/2020, East Midlands - Nottingham 1 Research Ethics Committee (HRA1 Meeting Room, The Old Chapel, Royal Standard Place, Nottingham NG1 6FS; +44 (0)207 104 8115; Nottingham1.rec@hra.nhs.uk), ref: 20/EM/0237

Study design

Multi-centre randomized waitlist controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files for parents (ISRCTN10903290_PIS_parent_v4.0_27Oct2020), for participants aged 11-15 years (ISRCTN10903290_PIS_11to15yrs_v0.3_27Oct2020), and for participants aged 16-24 years (ISRCTN10903290_PIS_16to24yrs_v4.0_27Oct2020)

Condition

Psychosocial oncology and survivorship, mental health, psychological wellbeing, young brain tumour survivors, malignant neoplasms of eye, brain and other parts of central nervous system

Intervention

The study aims to recruit 72 patients in total over a 12 month period. The researchers and clinical staff at each site will identify eligible participants according to the inclusion and exclusion criteria. Eligible participants will be provided with an age-appropriate information sheet by the clinical team and researcher who will invite the patient and parent (if desired in over 16-year-olds) to participate during their clinical visit. They will also provide an overview of the study and what it entails. Adequate time will be given to families to read the information and decide whether they would like to participate. If those approached decide they would like to participate informed assent will be sought from participants under 16 years old and informed consent from their parents. Informed consent will directly be sought from participants aged 16 and over.

All of those recruited will be asked to express interest and consent to taking part in qualitative interviews after their treatment. Up to 15 of those consenting will be approached to take part in interviews where participants can describe their experience of the study and treatment they received.

Treatment within the study will involve up to 12 sessions of ACT, each lasting 1 h, delivered weekly over video-conferencing. Participants will then be randomly placed (1:1 ratio) into one of two groups, either ACT offered either straight away or after a 12-week wait. Randomisation will be conducted using established randomisation software (https://www.sealedenvelope.com/). Researchers and participants will not be blind to trial arm allocation. Treatment will begin with written and verbal guidance on the use of video-conferencing software, how to use it safely, and how to get the most out of the medium.

Receiving treatment via video-conferencing will be the default modality for delivery. However, face-to-face treatment will be offered if internet access or appropriate device use is not possible for participants who are otherwise eligible and willing to meet in person. The reasons given for declining participation will be routinely sought, where patients are happy to give a reason, so that face-to-face inclusion can be offered. Any face-to-face meetings will be aligned with COVID-19 safety restrictions and guidelines at the time. Video-conferencing delivery will be supported with telephone contact to enable contingency management for any difficulties with internet connection that may be experienced.

At baseline, 3, 6, 9, and 12-month follow-up participants (and their parents for those under 16) will be asked to complete a series of health-related questionnaires to assess any changes over the course of their involvement. Those identified to take part in experiential interviews will be invited to conduct this interview after they have completed their final ACT session. Participants will be asked to complete the following questionnaires:
1. Strengths and Difficulties Questionnaire
2. Generalised Anxiety Disorder assessment
3. Patient Health Questionnaire for depression
4. Euroqol quality of life assessment
5. World Health Organisation wellbeing index
6. Patient-Reported Outcomes Measurement Information System- Satisfaction with Social Roles and Activities
7. Avoidance and Fusion Questionnaire for Youth (for participants aged 11 to 15 years)
8. Acceptance and Action Questionnaire (for participants aged 16 to 24 years)
9. Client Service Receipt Inventory (at 3 and 12 months only)
10. Experience of Service Questionnaire (at3 and 6 months only)
The parent/carer of participants aged 11 to 15 years will be asked to complete appropriate versions of the Strengths and Difficulties Questionnaire and the Client Service Receipt Inventory.

A statistician will be consulted for advice on the analysis. Feasibility and acceptability will be assessed by comparing the number of participants approached with the number recruited and the proportion of participants completing treatment. Analysis of clinical change will compare 3-month outcomes of those receiving ACT straight away with those waiting for the same period. Change in outcomes will also be measured over the 12-month follow-up period. Thematic analysis will be utilised for the interview data.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Psychological inflexibility measured using the Acceptance and Action Questionnaire II (AAQ-II) for 16-24-year-olds and the Avoidance and Fusion Questionnaire for Youth (AFQ-Y8) for 11-15-year-olds at baseline, 3, 6, 9, and 12 months
2. Wellbeing measured using the World Health Organisation wellbeing index (WHO-5) at baseline, 3, 6, 9, and 12 months; and the Outcome Rating Scale at baseline, each treatment session, then at 3, 6, 9, and 12 months
3. Generalised anxiety measured using the Generalised Anxiety Disorder assessment (GAD-7) at baseline, 3, 6, 9, and 12 months
4. Depression measured using the Patient Health Questionnaire (PHQ-9) at baseline, 3, 6, 9, and 12 months
5. Quality of life assessed using the Euroqol 5-dimensions 3-levels (EQ-5D-3L) for 16-24-year-olds and the Euroqol 5-dimensions youth version (EQ-5D-Y) at baseline, 3, 6, 9, and 12 months
6. Social engagement measured with the Patient-Reported Outcomes Measurement Information System, Satisfaction with Social Roles and Activities (PROMIS) at baseline, 3, 6, 9, and 12 months
7. Functioning assessed using the Strengths and Difficulties Questionnaire (SDQ) at baseline, 3, 6, 9, and 12 months
8. Health service usage measured using the Client Service Receipt Inventory (CSRI) at baseline 3 and 12 months
9. The credibility of the treatment assessed using the Credibility/Expectancy Questionnaire (CEQ) at baseline and at session 2 of treatment
10. Patient evaluations of treatment assessed using the Evaluation of Service Questionnaire (ESQ) at 3 months (for those in the immediate treatment arm) or 6 months (for those in the waitlist arm).

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/09/2018

Overall trial end date

01/01/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 11 to 24 years
2. Have had a historical primary diagnosis of brain tumour
3. Have stable disease and either off treatment or on low-intensity treatment
4. Sufficient understanding of English to engage with the intervention (spoken and written), as judged by the assessing clinician
5. Sufficient cognitive, sensory, and speech capabilities to take part in the intervention
6. Oral and written informed consent to participate in the study given by participants (or their parents if under 16)
7. Participants give written assent if under 16 years old
8. Access to the internet and appropriate devices to receive treatment over video-conferencing (the default modality for delivery). However, face-to-face treatment will be offered if internet access or appropriate device use is not possible for participants who are otherwise eligible.

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

Planned Sample Size: 72; UK Sample Size: 72

Participant exclusion criteria

1. Previous structured behavioural intervention within the last 6 months
2. Previous or current alcohol/substance dependence, psychosis, suicidality, or anorexia nervosa
3. Moderate/severe intellectual disability
4. Immediate risk to self or others
5. Parent or child not able to speak or read/write English

Recruitment start date

01/01/2021

Recruitment end date

31/12/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Trust Headquarters Queens Medical Centre Derby Road
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

University Hospitals Bristol NHS Foundation Trust
Marlborough Street
Bristol
BS1 3N
United Kingdom

Trial participating centre

Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital Freeman Road High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor information

Organisation

Nottingham University Hospitals NHS Trust

Sponsor details

Trust Headquarters
R&I
Room 2600
C Floor
South Block
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44(0)115 970 9049
researchsponsor@nuh.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nuh.nhs.uk/

Funders

Funder type

Charity

Funder name

Brain Tumour Charity

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

31/12/2023

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

26/11/2020: Trial’s existence confirmed by the National Institute for Health Research (NIHR).