Finding My Way UK: an investigation of the benefits of online psychological support for cancer survivors
| ISRCTN | ISRCTN14317248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14317248 |
| IRAS number | 288469 |
| Secondary identifying numbers | CPMS 48313, IRAS 288469 |
- Submission date
- 18/03/2021
- Registration date
- 08/04/2021
- Last edited
- 20/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The North West has a high rate of cancer diagnosis and deaths compared to the rest of the UK. Over one-third of cancer patients report anxiety or depression, three-quarters report psychological distress, and pilot work has confirmed high levels of psychological and supportive care needs that patients in the North West of the UK would like more support with. There is a lack of evidence about what might best reduce distress in UK cancer patients. ‘Finding My Way’ is a web-based programme developed in Australia. It contains six sections that help patients to better cope with the consequences of cancer treatment. In Australian research, cancer survivors who completed ‘Finding My Way’ reported reduced psychological distress and used fewer healthcare services. This study will test whether ‘Finding My Way’ is helpful to UK patients, potentially saving the NHS valuable resources.
Who can participate?
People aged 16 years and over who have received a cancer diagnosis within the last 6 months and who have received anti-cancer treatment with curative intent
What does the study involve?
Participants will be randomly allocated to one of two groups. Participants in the ‘immediate access’ group will receive immediate access to the Finding My Way programme, which is an online coping programme for UK-based cancer survivors. The ‘waitlist control’ group will immediately be provided with an information pack about other psychological services they can access. The ‘waitlist control’ group will then also receive access to the Finding My Way programme once they have finished all other studies activities. All participants will be sent a link to complete a series of questionnaires at the start of the study and 3 and 6 weeks after their assignment to either study group, and then again 3 months and 6 months after that. These questionnaires will ask about participants’ mental health, quality of life, and health service utilisation.
What are the possible benefits and risks of participating?
Based on findings from an Australian study that tested the Australian version of Finding My Way, the researchers have evidence to suggest that participants may experience reduced distress after completing the UK-adapted version of the Finding My Way online programme. The Australian study also found that participants who completed Finding My Way were better able to self-manage their symptoms and did not need to use as many other health care services. The risks associated with taking part in this study are low. Nevertheless, reading some material may trigger difficult thoughts and strong emotions.
Where is the study run from?
University of Chester (UK)
When is the study starting and how long is it expected to run for?
March 2020 to May 2023
Who is funding the study?
North West Cancer Research (UK)
Who is the main contact?
Prof Nick Hulbert-Williams, nick.hulbert-williams@edgehill.ac.uk
Contact information
Scientific
Edge Hill University
St Helens Road
Ormskirk
L39 4QP
United Kingdom
| Phone | +44 (0)1695 657684 |
|---|---|
| nick.hulbert-williams@edgehill.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Finding My Way UK: adaptation and replication testing of the benefits of online psychological support for cancer survivors |
| Study hypothesis | 1. The UK-adapted Finding My Way programme reduces cancer-specific distress more than an information pack signposting local support services. 2. The UK-adapted Finding My Way programme reduces anxiety, depression and stress more than an information pack signposting local support services. 3. The UK-adapted Finding My Way programme improves quality of life more than an information pack signposting local support services. 4. The UK-adapted Finding My Way programme improves psychological adjustment to cancer more than an information pack signposting local support services. 5. The UK-adapted Finding My Way programme reduces health service utilisation more than an information pack signposting local support services. 6. Social support moderates the effect of the UK-adapted Finding My Way programme on cancer-specific distress; depression, anxiety and stress; quality of life; psychological adjustment to cancer; and health service utilisation. 7. Vulnerability to distress moderates the effect of the UK-adapted Finding My Way programme on cancer-specific distress; depression, anxiety and stress; quality of life; psychological adjustment to cancer; and health service utilisation. 8. Motivation to seek information moderates the effect of the UK-adapted Finding My Way programme on cancer-specific distress; depression, anxiety and stress; quality of life; psychological adjustment to cancer; and health service utilisation. 9. Psychological flexibility mediates the effect of the UK-adapted Finding My Way programme on cancer-specific distress. |
| Ethics approval(s) | Approved 03/03/2021, Wales REC 4 (Health and Care Research Wales Support Centre, Castlebridge 4, Wales REC 4, CF11 9AB, UK; +44 (0)2920230457; Wales.REC4@wales.nhs.uk), REC ref: 21/WA/0029 |
| Condition | Online psychological support for cancer survivors |
| Intervention | Randomisation Prior to the beginning of the study, the Liverpool Clinical Trials Centre will create the randomisation code for the study and set up a randomisation portal to be used by unblinded members of the research team. This system will be set up such that each participant in the study will be randomised to either the active intervention arm of the study or the waitlist control arm in a 1:1 ratio. Intervention Arm Participants in the intervention arm of the trial will receive immediate access to the UK-adapted Finding My Way programme. The Finding My Way programme is composed of six modules, which address the following topics: 1. Starting treatment: This module provides guidance on working with the medical team, including assertive communication and decision making. 2. Coping with physical symptoms and side effects: This module provides information about fatigue, pain, and insomnia and provides activity pacing worksheets and relaxation audio tracks. 3. Coping with emotional distress: This module covers depression, anxiety, anger and stress and includes both cognitive restructuring worksheets and mindfulness audio tracks. 4. Body image, identity, and sexuality: This module includes psychosexual worksheets and therapeutic writing activities. 5. Your family and friends: This module provides further guidance on assertive communication and needs assessment worksheets. 6. Completing treatment: This module includes self-management strategies to facilitate healthy lifestyles. One new module is made available to participants each week, such that the Finding My Way Programme runs over a total of 6 weeks. The programme also includes one booster module summarizing key programme strategies, including sign-posting to material in the first six modules and some additional text and video content related to survivorship, which is made available to participants 1 month after the completion of the main 6-week programme. Participants will complete a battery of questionnaires assessing their psychological functioning, quality of life and health service utilisation 3 weeks and 6 weeks after receiving access to the Finding My Way programme. The researchers will administer the same battery of questionnaires at 3-month and 6-month follow-up. The Waitlist-Control Group Participants in the waitlist-control group will receive an information pack signposting them to psychological support services that they can access. They will receive access to the UK-adapted Finding My Way programme after they have completed 6-month follow-up data collection. Participants will complete a battery of questionnaires assessing their psychological functioning, quality of life and health service utilisation 3 weeks and 6 weeks after receiving their information pack. We will administer the same battery of questionnaires at 3-month and 6-month follow-up. |
| Intervention type | Behavioural |
| Primary outcome measure | Cancer-specific distress measured by the Post-Traumatic Stress Scale measured at baseline, mid-point assessment, post-treatment assessment, 3-month follow-up assessment, and 6-month follow-up assessment |
| Secondary outcome measures | 1. Depression, anxiety, and stress measured by the Depression, Anxiety, and Stress Scales – 21 item version (DASS-21) at baseline, mid-point assessment, post-treatment assessment, 3-month follow-up assessment, and 6-month follow-up assessment 2. Quality of life measured by the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (version 3.0) (QLQ-C30) at baseline, mid-point assessment, post-treatment assessment, 3-month follow-up assessment, and 6-month follow-up assessment 3. Psychological adjustment to cancer measured by the Psychological Impact of Cancer (PIC) Scale at baseline, mid-point assessment, post-treatment assessment, 3-month follow-up assessment, and 6-month follow-up assessment 4. Health service utilisation measured by the UK Cancer Costs Questionnaire at baseline, mid-point assessment, post-treatment assessment, 3-month follow-up assessment, and 6-month follow-up assessment 5. Social support measured by the MOS Social Support Survey at baseline 6. Vulnerability to distress measured by the Difficulties in Emotion Regulation Scale at baseline 7. Motivation to seek information measured by the Miller Behavioural Style Scale at baseline 8. Psychological flexibility measured by the CompACT at baseline, mid-point assessment, post-treatment assessment, 3-month follow-up assessment, and 6-month follow-up assessment |
| Overall study start date | 01/03/2020 |
| Overall study end date | 31/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 294; UK Sample Size: 294 |
| Total final enrolment | 289 |
| Participant inclusion criteria | 1. Been diagnosed with cancer in the past 6 months 2. Have received anti-cancer treatment with curative intent 3. Aged 16 years or over 4. Sufficiently proficient in English to provide informed consent and use the online programme 5. Able to access the internet 6. Currently have (or willing to set up) an active email address |
| Participant exclusion criteria | Severe comorbidity considered by the screening nurse to interfere with the individual’s ability to complete the requirements of the study or provide informed consent (e.g., intellectual disability or neurological impairment) |
| Recruitment start date | 12/04/2021 |
| Recruitment end date | 26/08/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Liverpool Road
Chester
CH2 1UL
United Kingdom
Ysbyty Gwynedd
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
Whinney Heys Road
Blackpool
FY3 8NR
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Clatterbridge Road
Bebington
CH63 4JY
United Kingdom
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Poplar Grove
Stockport
SK2 7JE
United Kingdom
Stott Lane
Salford
M6 8HD
United Kingdom
Sponsor information
University/education
c/o Ms Marie-Anne O'Neil
Research & Knowledge Transfer Office
University of Chester
Parkgate Rd
Chester
CH1 4BJ
England
United Kingdom
| Phone | +44 (0)1244511481 |
|---|---|
| m.oneil@chester.ac.uk | |
| Website | http://www.chester.ac.uk/ |
"ROR" |
https://ror.org/01drpwb22 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- North West Cancer Research Fund, NWCR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The clinical trial data will be published in relevant peer-reviewed journals as a joint effort of the Trial Steering Group without undue delay following the completion of the study. |
| IPD sharing plan | The quantitative datasets generated during and/or analysed during the current study will be stored in a publicly available repository. The researchers will share anonymised data via the Open Science Framework. These data will include the primary and secondary outcome measures, demographic and clinical data, as well as any moderating or mediating variables we ultimately include in all planned and exploratory analyses. The researchers will not include the name of participants’ recruiting cancer centre in the interest of maintaining participant anonymity. Participants will explicitly consent for their anonymised data to be shared with other members of the research community. Given the limited scope of the qualitative interview schedule, and the ethical risks involved in releasing qualitative data openly, the researchers do not currently plan to share data from this aspect of the trial. They will, however, review best practice guidelines as they change over the course of the project, and they will review this aspect of the data sharing policy at the time of project completion. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V2 | 15/02/2021 | 08/04/2021 | No | No |
| Protocol file | version 4 | 16/08/2021 | 08/09/2021 | No | No |
| Protocol article | Adaptation Report and Protocol | 20/09/2021 | 21/09/2021 | Yes | No |
| Protocol file | version 5 | 09/11/2021 | 28/01/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
20/09/2024: The intention to publish date was changed from 31/10/2023 to 31/07/2025.
28/11/2023: Total final enrolment added.
27/11/2023: Contact details updated.
26/08/2022: The recruitment end date was changed from 31/08/2022 to 26/08/2022.
23/08/2022: Record confirmed up to date.
28/01/2022: The following changes were made to the trial record:
1. The protocol (not peer reviewed) has been uploaded as an additional file.
2. The recruitment end date was changed from 28/02/2022 to 31/08/2022.
3. The overall trial end date was changed from 31/10/2022 to 31/05/2023.
4. Stockport NHS Foundation Trust and Northern Care Alliance NHS Foundation Trust were added as trial participating centres.
21/09/2021: Publication reference added.
20/09/2021: Internal review.
08/09/2021: The following changes have been made:
1. The trial participating centres "East Lancashire Hospitals NHS Trust", "Bolton NHS Foundation Trust", and "Bradford Teaching Hospitals NHS Foundation Trust" have been added.
2. The protocol (not peer reviewed) has been uploaded as an additional file.
08/04/2021: Uploaded protocol Version 2, 15 February 2021 (not peer reviewed).
18/03/2021: Trial's existence confirmed by the NIHR.
