Integrated short-term palliative rehabilitation in incurable cancer
| ISRCTN | ISRCTN16705336 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16705336 |
| IRAS number | 328722 |
| Secondary identifying numbers | IRAS 328722 |
- Submission date
- 24/04/2023
- Registration date
- 27/04/2023
- Last edited
- 25/03/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
Cancer is one of the main causes of illness, burden and death in Europe. The Joint Research Centre (JRC) of the EU estimated 2.7 million new cancer cases. For all cancers, between 53-79% of men and 41-62% of women are diagnosed with incurable disease. Their cancer treatment is life-prolonging but will not cure the disease.
Cancer is also a major and growing contributor to disability (loss of function). Recent global estimates suggest a loss of 382 disability-adjusted life years per 1000 individuals. Disability is a poorly recognised and undertreated consequence of incurable cancer. Over time, loss of function results in people not being able to continue with valued roles and routines, to manage usual household and social activities, and to self-care. One-third of adults with cancer require assistance to perform basic activities like washing and dressing, and half need help with extended activities like shopping and transportation. Disability reduces quality of life and well-being. Disability related to daily activity is closely related to unplanned hospital admissions and mortality.
Palliative rehabilitation empowers people with incurable conditions to actively manage their condition themselves, enabling them to live fully and enjoy the best health-related quality of life possible, including cancer towards the end of life. It aims to reduce symptoms and help people to stay independent and socially active. WHO policy on Universal Health Coverage states both rehabilitation and palliative care as essential, quality health services. It recommends they be integrated within and between primary, secondary, and tertiary health systems using a multi-professional workforce. While integrated rehabilitation has been achieved for people with chronic respiratory, cardiac and stroke conditions, this is not the case for people with cancer, especially those living with incurable disease. Access to palliative care services has increased but access to rehabilitation remains varied.
In this study, we are evaluating a rehabilitation intervention that has been designed to meet the needs of people living with advanced cancer. The study is taking place in countries across Europe, and we plan to recruit 340 patients from hospitals. We aim to find out if and how the rehabilitation intervention affects the people who take part in the study. We will also study how it fits in with current healthcare services.
Who can participate?
This study is suitable for patients aged 18 or over, diagnosed with advanced solid cancer: lung, colorectal, breast, prostate or other, irrespective of timing in relation to any oncology or palliative care treatments.
What does the study involve?
After signing the informed consent, the participation in this trial will last 16 weeks. Participation in this trial is voluntary and the participants can withdraw any time.
During the first face to face visit, participants will be randomly allocated to receive either INSPIRE rehabilitation intervention + usual care or usual care only. The random allocation will be done using a software maintained by the King’s Clinical Trials Unit.
The trial schedule depends on group allocation:
Participants allocated to usual care only will be asked to complete questionnaires at weeks 4, 8 and 16 either on their own, with a help of a friend or family member, or with the researcher over the telephone or in person. It should take 30 – 45 minutes to compete all the questions.
Participants allocated to the INSPIRE rehabilitation + usual care will be offered up to 3 rehabilitation visits in addition to the questionnaire completion at weeks 4, 8 and 16. Each visit will last 30 -90 minutes.
- 1st rehabilitation visit will be face to face and will be scheduled no later than 14 days after joining the trial. During this visit, a rehabilitation action plan will be put together.
- 2nd rehabilitation will be scheduled around 4 weeks, but no later than 5 weeks after joining the trial.
- 3rd rehabilitation visit will be scheduled around 6 weeks, but no later than 7 weeks after joining the trial.
Both visits 2 and 3 can be face to face, via telephone or via video call and participants will have the opportunity to review and, if needed, change their rehabilitation action plan.
There won’t be any changes in usual care for participants that have been allocated to the rehabilitation intervention group.
Participants allocated to the INSPIRE rehabilitation intervention may also be invited to an optional one-to-one interview with a member of a research team. The interview will last around 30-60 minutes
At the week 28 the research team will look at the participants medical notes to see how they’re getting on; however participants will not need to do anything at this time.
The trial team will collect participants’ medical history and demographic data; however demographic data will be anonymised and only year of birth and initials will be shared with the research teams. All data will be stored on a password-protected database to which only authorised individuals will have access.
What are the possible benefits and risks of participating?
The study is designed to help us understand if the rehabilitation intervention can benefit people living with advanced cancer. This is a very low risk study. This study will require attending appointments and complete questionnaires which might be tiring for some people. It is not yet clear if taking part in this study will be directly beneficial for the study participants. however, taking part should help to improve future care and research, to help care for people with similar conditions in the future.
Where is the study run from?
INSPIRE is coordinated by King's College London (UK) with centres in the UK, Italy, Denmark, Norway, and France.
When is the study starting and how long is it expected to run for?
September 2022 to August 2026
Who is funding the study?
Funding to conduct the trial in the European Union is provided by HORIZON-HLTH-2021-DISEASE-04. In the UK this study is funded by UKRI Innovate (UKRI Reference Number: 10047799)
Who is the main contact?
INSPIRE@kcl.ac.uk
Contact information
Public
King's College London
Institute of Psychology, Psychiatry and Neuroscience
16 De Crespigny Park
London
SE5 8AB
United Kingdom
 ORCID ID |
0009-0008-5102-8907 |
|---|---|
| Phone | +44 (0)20 7848 0532 |
| sylvia.1.wilczynska@kcl.ac.uk |
Study information
| Study design | Multinational parallel group randomized controlled assessor blind superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community, Hospital |
| Study type | Treatment |
| Scientific title | Integrated Short-term Palliative Rehabilitation to improve quality of life and equitable care access in incurable cancer: A multi-national randomised controlled trial. |
| Study acronym | INSPIRE |
| Study hypothesis | Palliative rehabilitation in addition to usual care is more effective than usual care at improving health-related quality of life in patients with incurable solid cancer |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Advanced incurable solid cancer: lung, colorectal, breast, prostate, etc. |
| Intervention | The intervention being tested is Integrated Short-term Palliative Rehabilitation. It comprises up to 3 manualised sessions (face to face and/or remotely (via telephone or video-conference) delivered by a rehabilitation practitioner (typically a physiotherapist or occupational therapist). Core components focus on (i) self-management of symptoms, (ii) physical activities and fitness, and (iii) social participation, with explicit use of behaviour change techniques with goal setting and action planning. The rehabilitation practitioner works in partnership with the person with incurable cancer, and those important to them, to support and optimise their function. Sessions focus on outcomes each person has said are important to them. The rehabilitation practitioner attends to practical, physical, emotional, psychological, and existential concerns impacting on function, either directly within the intervention or indirectly through onward referral. The intervention allows for individual tailoring and flexibility in location, timing and frequency of sessions and content over a 7-week intervention period. Participants can receive a minimum of two rehabilitation sessions and a maximum of three rehabilitation sessions. It is delivered in addition to any usual services delivered by the participant's oncology team and palliative care team. The randomisation ration is 1:1 (palliative rehabilitation + usual care : usual care only) |
| Intervention type | Other |
| Primary outcome measure | Health related quality of life - Functional Assessment of Cancer Therapy (FACT) General scale at 8 weeks |
| Secondary outcome measures | 1. Functional Assessment of Cancer Therapy (FACT) General scale at 4 and 16 weeks 2. Disability - World Health Organization Disability Assessment Schedule (WHODAS 2.0) at 8 and 16 weeks 3. Symptoms- Palliative Outcomes Scale – Symptoms (POS-S) at 8 and 16 weeks 4. Goal attainment- Goal attainment scale (GAS-Light) at 8 and 16 weeks 5. Client Service Receipt Inventory at 8 and 16 weeks |
| Overall study start date | 01/09/2022 |
| Overall study end date | 31/08/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 340 |
| Participant inclusion criteria | 1. Aged 18 years or older 2. Diagnosis of incurable solid cancer: lung, colorectal, breast, prostate or other, irrespective of timing in relation to any oncology or palliative care treatments 3. Eastern Cooperative Oncology Group performance status 2-3 4. Able to provide informed consent and complete trial assessments in available languages. |
| Participant exclusion criteria | 1. Blood cancers: Leukaemia, Lymphoma, Myelodysplastic Syndromes (MDS), Myeloproliferative Disorder (MPD), Multiple Myeloma 2. Currently receiving specialist rehabilitation* for their cancer or co-morbidity-related dysfunction, or received within the two weeks prior to consent 3. Clinician rated prognosis of less than 3 months |
| Recruitment start date | 03/10/2023 |
| Recruitment end date | 02/10/2025 |
Locations
Countries of recruitment
- Denmark
- England
- France
- Italy
- Norway
- United Kingdom
Study participating centres
London
SE5 9RS
United Kingdom
Lyon
69008
France
Milan
20133
Italy
Reggio Emilia
42122
Italy
København
2100
Denmark
5007
Norway
Sponsor information
University/education
Principal’s Office Department
Guy’s Campus
London
SE1 4UL
England
United Kingdom
| Phone | +4420 7188 4557 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- UKRI
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Horizon Europe, Horizon Europe Programme, Framework Programme, Horizon Europe, EU Framework Programme, Horizon
Results and Publications
| Intention to publish date | 31/08/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Open access publications: Findings of the trial, process and implementation evaluation and an equity and inclusivity evaluation will be published in peer-reviewed journals with open access, in line with King’s College London’s Research Publications Policy. This policy recognises that open access provides greater visibility of research worldwide, supports research collaborations, and ensures reach to the widest possible audience. . |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 17/11/2023 | 25/03/2024 | No | No |
Additional files
Editorial Notes
25/03/2024: Protocol uploaded.
31/05/2023: The following changes have been made and the plain English summary updated accordingly:
1. Belgium and Scotland were removed from the countries of recruitment.
2. The University of Edinburgh, European Association of Palliative Care and European Cancer Patient Coalition were removed from the study participating centres.
27/04/2023: Trial's existence confirmed by UKRI.
