Condition category
Cancer
Date applied
03/11/2020
Date assigned
04/11/2020
Last edited
06/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andy Turner

ORCID ID

http://orcid.org/0000-0001-6538-4242

Contact details

Centre for Intelligent Healthcare
Faculty of Health and Life Sciences
Coventry University
Priory Street
Coventry
CV1 5FB
United Kingdom
+44 (0)7599782465
hsx116@coventry.ac.uk

Type

Public

Additional contact

Dr Hayley Wright

ORCID ID

http://orcid.org/0000-0003-2199-8255

Contact details

Centre for Intelligent Healthcare
Faculty of Health and Life Sciences
Coventry University
Priory Street
Coventry
CV1 5FB
United Kingdom
+44 (0)7904118985
ab7764@coventry.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRRID: RR1-10.2196/24264

Study information

Scientific title

The Help to Overcome Problems Effectively (HOPE) programme for people living with cancer during COVID-19: a feasibility randomised waitlist controlled trial

Acronym

HOPE

Study hypothesis

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

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

Study design

Feasibility 1:1 randomized waitlist controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Other

Patient information sheet

See additional files

Condition

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

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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)

Overall trial start date

31/03/2020

Overall trial end date

02/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Total final enrolment

41

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

30/04/2020

Recruitment end date

03/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Coventry University
Priory Street
Coventry
CV1 5FB
United Kingdom

Sponsor information

Organisation

Coventry University

Sponsor details

Priory Street
Coventry
CV1 5FB
United Kingdom
+44 (0)2477657498
ethics.uni@coventry.ac.uk

Sponsor type

University/education

Website

http://www.coventry.ac.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of feasibility RCT results in Journal of Medical Internet Research. Raw data will be available to the research team only, as per study ethical approval.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical conditions.

Intention to publish date

01/05/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/11/2020: The participant information sheet was uploaded as an additional file. 04/11/2020: Trial’s existence confirmed by Coventry University