The digital Hope programme for people living with cancer during COVID-19

ISRCTN	ISRCTN79623250
DOI	https://doi.org/10.1186/ISRCTN79623250
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	IRRID: RR1-10.2196/24264
Sponsor	Coventry University
Funder	Investigator initiated and funded

Submission date: 03/11/2020
Registration date: 04/11/2020
Last edited: 08/11/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The COVID-19 pandemic has created additional challenges for people with cancer (PWC), both in terms of physical and mental health. PWC have reported concerns about the further risks to their health from COVID-19, increased anxiety relating to potential cancellation or reduction in treatments and advice from medical teams, and significant anxiety and fears of contracting COVID-19. During the UK lockdown, one in four PWC have experienced depression, anxiety and stress, and one in seven PWC experienced further decline in their physical health.

In response to the shortage of available, tailored self-management support for PWC, we co-designed a programme together with PWC, clinicians and other experts. This led to the group-based self-management programme: Help to Overcome Problems Effectively, known as the “HOPE Programme”, for survivors of all types of cancer, which was originally delivered in-person. The face-to-face version of the Hope Programme has been adapted for digital delivery, and initial evaluation suggests potential effects on anxiety, depression and positive wellbeing, with positive user evaluations. A feasibility randomised controlled trial (RCT) study is the next step in the testing of this digital intervention.

The aim of this study is to test the feasibility of a digitally delivered self-management programme for PWC.

Who can participate?
Macmillan Cancer Support hold a contact list of cancer patients who had expressed interest in attending an in-person Hope programme, which has been cancelled due to COVID-19. All patients on this list were invited to take part in the study and access the digital Hope Programme self-management course. Participants must be adults over the age of 18 years, with a cancer diagnosis of any type and at any stage, be located in the UK, have access to the internet and a device that will allow them to engage with the intervention, be fluent in English to be able to engage with all the material in the intervention, and must not have been recruited by Macmillan Cancer Support via the NHS.

What does the study involve?
Participants will be asked to complete an online consent form and health and wellbeing questionnaires including some sociodemographic questionnaires, at baseline. All study documents and questionnaires are presented online. Upon completion of consent and baseline questionnaires, participants will be randomly allocated to the intervention group (IG) or a waitlist control group (WLCG). The IG will have access to the Hope Programme starting the following week, and the WLCG will join a 6-week waiting list for the next Hope Programme. The study questionnaires will be completed at baseline, and again after 6 weeks, and then again at post-programme for the WLCG.

What are the possible benefits and risks of participating?
The digital Hope Programme has been shown to be helpful for a small group of people living with cancer in a study which did not have a control group. Participants may find the course helpful and/or may have suggestions for how it could be improved before it is put into a full scale clinical trial. Participants will be entered into a prize draw for £50 Amazon Gift vouchers for completion of all study questionnaires.
There are no direct risks of taking part in this study. Whilst we do not anticipate the questionnaires will cause any distress to participants, some of the questions will ask about their health, which may touch on topics that some participants may find sensitive. Participants are informed that they do not have to answer any questions that they are uncomfortable with. If participants do experience any distress from completing the questionnaires, they are encouraged to contact their GP, or the Samaritans.

Where is the study run from?
The study takes place completely online, and is run by Coventry University (UK).

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

Who is funding the study?
Investigator initiated and funded.

Who is the main contact?
Professor Andy Turner, hsx116@coventry.ac.uk

Contact information

Prof Andy Turner
Scientific

Centre for Intelligent Healthcare
Faculty of Health and Life Sciences
Coventry University
Priory Street
Coventry
CV1 5FB
United Kingdom

ORCID ID	0000-0001-6538-4242
Phone	+44 (0)7599782465
Email	hsx116@coventry.ac.uk

Dr Hayley Wright
Public

Centre for Intelligent Healthcare
Faculty of Health and Life Sciences
Coventry University
Priory Street
Coventry
CV1 5FB
United Kingdom

ORCID ID	0000-0003-2199-8255
Phone	+44 (0)7904118985
Email	ab7764@coventry.ac.uk

Study information

Primary study design	Interventional
Study design	Feasibility 1:1 randomized waitlist controlled trial
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN79623250_PIS.docx
Scientific title	The Help to Overcome Problems Effectively (HOPE) programme for people living with cancer during COVID-19: a feasibility randomised waitlist controlled trial
Study acronym	HOPE
Study objectives	The aim of this study is to test the feasibility of a digitally delivered self-management programme, Help to Overcome Problems Effectively (HOPE), for people with cancer (PWC). This will inform the design of a definitive randomised controlled trial (RCT). Additionally, preliminary assessment of the impact of the Hope programme, via secondary outcomes, will be used to assess signals of efficacy in a trial context. The planned primary outcomes (trail feasibility objectives) of the study are to investigate: · Recruitment rates for participation and for randomisation · Retention and follow-up rates as the participants move through the trial · Adherence rates to study procedures, intervention attendance, and engagement · Sample size and effect size estimation for a definitive trial · Progression criteria for a definitive trial The secondary outcomes are: · Measures of depression, anxiety, confidence to self-manage cancer (patient activation) and mental wellbeing, as indicated by scores on validated measures
Ethics approval(s)	Approved 28/04/2020, Coventry University Ethics Committee (Coventry University, Priory Street, Coventry, West Midlands, CV1 5FB, UK; no telephone number provided; ethics.uni@coventry.ac.uk), ref: P106024
Health condition(s) or problem(s) studied	Self-management for people with cancer
Intervention	This study will employ a feasibility, randomised wait-list control group design, to explore the feasibility of a trial of the digital Hope Programme for PWC. Randomisation is via Qualtrics survey platform, following completion of consent and baseline questionnaires. The intervention is a six-week digital self-management programme. Quantitative monitoring of participant progress through the online programme will be undertaken. Participants will be asked to complete standardised measures of depression, anxiety, mental wellbeing and confidence in managing their cancer.
Intervention type	Behavioural
Primary outcome measure(s)	Feasibility outcome measures 1. Recruitment rates for participation and randomisation will be collected through Qualtrics. All eligible participants identified by MCS will be sent a link to the Qualtrics study survey, so we will calculate recruitment rates from those providing consent and/or completing baseline questionnaires 2. Retention and follow-up rates. Follow up will be online. Participants who become lost to follow up will be identified through Qualtrics as those not completing post programme questionnaires. It is possible that these participants may still complete some or all of the Hope programme, and so participant retention can be identified separately through engagement with the Hope platform. Participants who explicitly request to be withdrawn from the study will be categorized accordingly, but we will not contact participants to obtain reasons for not completing questionnaires. 3. Adherence rates. The Hope platform collects user engagement data such as login frequency and duration, which assists the moderators with participant engagement and experience. Participants also have the option of receiving system generated automatic nudge reminders sent to their email address. We will analyse this user engagement data to generate usage patterns and provide an overview of session attendance and participant engagement. 4. Sample size and effect size estimation. To inform sample size estimation for a future definitive trial, we will calculate the standard deviations of the continuous secondary outcomes pertaining to depression, anxiety, mental wellbeing and confidence to manage their cancer. To estimate potential effect sizes for a primary outcome in a future definitive trial, namely change in scores on key secondary outcome measures from pre- to post programme, we will calculate the difference between the mean difference pre and post programme for the intervention and control groups and divide by the pooled standard deviation at baseline 5. Progression criteria We will collate the data from all participants in this feasibility RCT to inform progression to a definitive trial (all measured using the Hope platform): 5.1. Recruitment rate 5.2. Questionnaire completion rate 5.3. Programme completion rate
Key secondary outcome measure(s)	1. Sociodemographic and health questionnaire at baseline only, requesting the following personal information from participants: gender, age, ethnicity, marital status, highest level of education, employment and occupation, and some details about their cancer diagnosis and any other medical conditions. Preprogramme and postprogramme (i.e. 6 weeks post-randomisation): 2. The Patient Health Questionnaire (PHQ-9) (depression) 3. The Generalized Anxiety Disorder scale (GAD7) (anxiety) 4. The Warwick Edinburgh Mental Wellbeing Scale (WEMWBS) (mental wellbeing) 5. The Patient Activation Measure (PAM®) (knowledge, skills and confidence in patients and the extent to which people feel engaged and confident in taking care of their condition)
Completion date	02/09/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Total final enrolment	41
Key inclusion criteria	1. Diagnosis of any type of cancer, at any stage 2. Adult (18 years or over) 3. Located in the United Kingdom 4. Access to the internet and a device that will allow them to engage with the intervention 5. Fluent in English to be able to engage with all the material in the intervention 6. Not recruited via the NHS
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	30/04/2020
Date of final enrolment	03/05/2020

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Coventry University

Priory Street
Coventry
CV1 5FB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical conditions.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		05/11/2021	08/11/2021	Yes	No
Protocol article	protocol	04/12/2020	12/01/2021	Yes	No
Participant information sheet			06/11/2020	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN79623250_PIS.docx: uploaded 06/11/2020

Editorial Notes

08/11/2021: Publication reference added.
10/05/2021: The intention to publish date was changed from 01/05/2021 to 31/07/2021.
01/02/2021: Internal review.
12/01/2021: Publication reference added.
06/11/2020: The participant information sheet was uploaded as an additional file.
04/11/2020: Trial’s existence confirmed by Coventry University