SURECAN: Survivors rehabilitation evaluation after cancer
| ISRCTN | ISRCTN67900293 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67900293 |
| Secondary identifying numbers | CPMS 43122 |
- Submission date
- 18/11/2019
- Registration date
- 09/12/2019
- Last edited
- 15/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Some two million people in the UK are living with or beyond cancer -“cancer survivors”. About a third of these patients report poor quality of life (QoL), or well-being, due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work.
From talking to patients we have found that important aspects of QoL include physical abilities and psychological wellbeing. We surveyed cancer services to see what aftercare is provided and found it did not address important issues highlighted by patients. We therefore are in need of better aftercare for “cancer survivors”.
Since the best approaches are only moderately effective, we decided to adopt Acceptance and Commitment Therapy (ACT). ACT puts patients’ views about what they value most in their lives at the heart of the therapy, in order to improve their quality of life. ACT helps patients to accept what they cannot change (e.g. the cancer might recur) and commit themselves to goals they are able and want to achieve, based on their own values (e.g. becoming closer to loved ones). We know that exercise is helpful and return to work/vocational activity is important to many patients, therefore will integrate ACT with options for physical activity and work support, if these are deemed important by the patient (thus: ACT+).
This study will consist of a pilot RCT, which if meets set criteria will seamlessly progress into a definitive trial comparing ACT+ and usual aftercare, with usual aftercare only, answering if ACT+ with usual aftercare is more effective and cost-effective in improving the QoL of participants living with and beyond cancer than usual aftercare only.
Who can participate?
Patients aged 18 years or above who have completed cancer treatment in the past 24 months.
What does the study involve?
Patients will be randomly allocated to receive ACT+ and usual aftercare, or usual aftercare only for a 14 – 20 week period.
What are the possible benefits and risks of participating?
The benefit to participants is that the intervention may lead to improvements in their quality of life compared to the usual aftercare currently available, which is the aim of the SURECAN study.
The trial is considered to have a very low risk, but there is a risk of psychological distress. The therapy is designed to minimise this and the therapists delivering the therapy are fully trained and experienced to deal with such circumstances.
Where is the study run from?
1. Queen Mary University of London, UK (lead centre)
2. The Royal London Hospital, UK
3. Northern General Hospital, UK
4. University College London Hospitals NHS Foundation Trust, UK
5. North East London NHS Foundation Trust, UK
6. East London NHS Foundation Trust, UK
7. NHS City and Hackney CCG, UK
8. St. Pancras Hospital, UK
9. Cavendish Cancer Care, UK
When is the study starting and how long is it expected to run for?
February 2020 to January 2025
Who is funding the study?
National Institute for Health Research (NIHR), UK
Who is the main contact?
Imran Khan
surecan.study@qmul.ac.uk
Contact information
Public
58 Turner St
LONDON
E1 2AB
United Kingdom
 ORCID ID |
0000-0002-2069-7410 |
|---|---|
| Phone | +44 (0)2078822524 |
| surecan.study@qmul.ac.uk |
Study information
| Study design | Multi-centre pragmatic randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A multi-centre, pragmatic, randomised controlled trial of comparing enhanced Acceptance and Commitment Therapy (plus) added to usual aftercare, versus usual aftercare only |
| Study acronym | SURECAN |
| Study objectives | ACT+ with usual aftercare is more effective and cost-effective in improving the QoL of participants living with and beyond cancer than usual aftercare only |
| Ethics approval(s) |
Approved 20/01/2020, South West – Cornwall and Plymouth (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8079; cornwallandplymouth.rec@hra.nhs.uk), ref: 19/SW/0214 |
| Health condition(s) or problem(s) studied | Mental health, quality of life in cancer survivors |
| Intervention | Patients will be randomised with an allocation ratio 1:1 to enhanced Acceptance and Commitment Therapy (plus) added to usual aftercare (intervention), versus usual aftercare only (control). Acceptance and Commitment Therapy (ACT) puts patients’ views about what they value most in their lives at the heart of the therapy, to improve their quality of life. ACT helps patients to accept what they cannot change and commit themselves to goals they are able and want to achieve, based on their own values. If physical activity and work support are deemed important by the patient the relevant support will be integrated into the therapy (ACT+). Number of sessions The intervention will take the form of up to eight sessions at weekly or fortnightly intervals using different modalities of delivery to suit individual needs: face-to-face sessions, over the phone or skype. The first session will be conducted face-to-face with the therapist. The intervention will be introduced and participants will be provided with the ACT+ participant handbook. Therapy will be delivered by therapists trained in the approach i.e. ACT. They could be situated in Improving Access to Psychological Therapies (IAPT), specialist services, cancer psychological services, or cancer charities. Duration of sessions Each session will take around one hour to complete and will include further exercises to be completed at home in time for the next session. Scheduling of sessions All sessions should be scheduled and take place within a 14 - 20 week period starting from when a participant is allocated to the therapist (i.e. from randomisation). Control (usual aftercare) All participants in the study will receive usual aftercare provided by the NHS or support services. Participants randomised to the usual aftercare arm will receive a Macmillan Cancer Support leaflet about aftercare to all participants, to ensure that appropriate guidance is provided. Randomisation Allocation will be by stratified randomisation, overseen by the Pragmatic Clinical Trials Unit at Queen Mary, remote to researchers, to preserve strict allocation concealment. Participants will be randomised in a 1:1 ratio with 172 participants in each arm. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Functional Assessment of Cancer Therapy: General scale (FACT-G) at 12 months 2. Primary health economics outcome: Quality-adjusted life-years based on EQ5D5L and net monetary benefit at 12 months |
| Secondary outcome measures | Self-reported by patient response to questionnaires: 1. Quality of life measured using Functional Assessment of Cancer Therapy: General scale (FACT-G) at screening, baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 2. Health economics measured using the Client Service Receipt Inventory (CSRI) at baseline, 16 weeks, 52 weeks, 2 years 3. Fear of cancer recurrence measured using the Fear of Cancer Recurrence (FCR4) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 4. Depression and anxiety measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 5. Fatigue measured using the Chalder Fatigue Scale (CFS) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 6. Impact of cancer on QoL measured using the Impact Of Cancer scale (IOC) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 7. Psychological flexibility measured using the Acceptance and Action Questionnaire (AAQ-II) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 8. Values measured using the Valuing Questionnaire (VQ) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 9. Goal-directed behaviour measured using the Committed Action Questionnaire (CAQ) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years 10. Beliefs about emotions measured using Beliefs about Emotions Scale (BES) at baseline, 7 weeks, 16 weeks, 52 weeks, 2 years |
| Overall study start date | 09/04/2018 |
| Completion date | 29/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 344 in total: 45 recruited for internal pilot and 299 recruited for main trial |
| Key inclusion criteria | Current inclusion criteria as of 28/11/2023: 1. Within 24 months of having completed cancer treatment, (or about to complete) with curative intent for breast cancer, lower gastro-intestinal cancer, urological cancer, a haematological cancer, head and neck cancer, and any other common cancer with good survival 2. Aged 18 years or over 3. Participant’s GP practice falls within a participating IAPT service catchment, or if other psychological service provider, participant resides within their catchment area 4. Ability to give informed consent 5. Sufficient fluency in spoken English to be able to participate in a talking-based therapy delivered in English 6. With a score of 78 or less on the Functional Assessment of Cancer Therapy – General (FACT-G) _____ Previous inclusion criteria: 1. Within 24 months of having completed cancer treatment, (or about to complete) with curative intent for breast cancer, colorectal cancer, prostate cancer, a haematological cancer, head and neck cancer, and any other common cancer with good survival 2. Aged 18 years or over 3. Participant’s GP practice falls within a participating IAPT service catchment, or if other psychological service provider, participant resides within their catchment area 4. Ability to give informed consent 5. Sufficient fluency in spoken English to be able to participate in a talking-based therapy delivered in English 6. With a score of 78 or less on the Functional Assessment of Cancer Therapy – General (FACT-G) |
| Key exclusion criteria | Current exclusion criteria as of 28/11/2023: 1. Will not have not completed their cancer treatment by the commencement of the trial (excepting those receiving long-term, ongoing maintenance treatment e.g. androgen suppression therapy in urological cancer) 2. Receiving palliative or terminal care 3. Currently receiving another psychological intervention (NB participants taking antidepressants or anxiolytic drugs remain eligible) 4. Other serious co-morbid condition which would make it difficult for the participant to receive a talking-based one-to one intervention 5. Require urgent psychiatric or clinical psychology assessment _____ Previous exclusion criteria: 1. Will not have not completed their cancer treatment by the commencement of the trial (excepting those receiving long-term, ongoing maintenance treatment e.g. androgen suppression therapy in prostate cancer) 2. Receiving palliative or terminal care 3. Currently receiving another psychological intervention (NB participants taking antidepressants or anxiolytic drugs remain eligible) 4. Other serious co-morbid condition which would make it difficult for the participant to receive a talking-based one-to one intervention 5. Require urgent psychiatric or clinical psychology assessment |
| Date of first enrolment | 01/03/2021 |
| Date of final enrolment | 30/11/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Whitechapel Rd
London
E1 1BB
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
London
NW1 2BU
United Kingdom
Whitechapel
London
E1 2AB
United Kingdom
Marsh Way
Rainham
Ilford
IG3 8XJ
United Kingdom
Aldgate
London
E1 8DE
United Kingdom
The Lawson Practice
85 Nuttall Street
London
N1 5HZ
United Kingdom
4 St. Pancras Way
London
NW1 0PE
United Kingdom
Sheffield
S10 2GB
United Kingdom
Sponsor information
University/education
58 Turner Street
London
E1 2AB
England
United Kingdom
| Phone | +44 (0)2078822524 |
|---|---|
| surecan.study@qmul.ac.uk | |
| Website | http://www.surecanstudy.qmul.ac.uk |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results are planned to be published in peer reviewed scientific journals, conference presentations, publication on study website and submission to regulatory authorities. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Approaches to share data will be handled by the QMUL PCTU’s Data Sharing Committee which includes a Senior Statistician and a Senior Data Manager. All requests for data sharing will follow the PCTU data sharing procedures, regarding assessing access requests with guarantees of confidentiality and pre-specified analysis plans. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 5.0 | 02/10/2023 | 28/11/2023 | No | No |
| Protocol article | 02/04/2024 | 03/04/2024 | Yes | No | |
| Statistical Analysis Plan | 30/01/2025 | 30/01/2025 | Yes | No |
Additional files
Editorial Notes
15/04/2025: The following changes were made to the trial record:
1. The overall end date was changed from 30/04/2025 to 29/01/2025.
2. The ethics approval was added.
30/01/2025: Publication reference added.
03/04/2024: Publication reference and total final enrolment added.
28/11/2023: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The overall end date was changed from 08/10/2023 to 30/04/2025.
3. The recruitment end date was changed from 31/03/2023 to 30/11/2023.
4. The inclusion criteria were changed.
5. The exclusion criteria were changed.
6. The plain English summary was updated to reflect these changes.
02/02/2022: The recruitment end date has been changed from 31/07/2022 to 31/03/2023.
13/04/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/10/2020 to 01/03/2021.
2. The recruitment end date was changed from 31/12/2021 to 31/07/2022.
20/04/2020: The recruitment start date has been changed from 01/02/2020 to 01/10/2020.
06/12/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)
