CancerINSPIRENCT05984797
Integrated Short-Term Palliative Rehabilitation in Incurable Cancer
A study testing Integrated Short-term Palliative Rehabilitation in people with Cancer, run by King's College London at 11 sites in 5 countries.
Trial summary
The goal of this intervention trial is to determine if 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Integrated Short-term Palliative Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 11 sitesin 5 countries
- Study dates
- 18 Apr 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Diagnosis of incurable solid cancer: lung, colorectal, breast, prostate or other, irrespective of timing in relation to any oncology or palliative care treatments
- Eastern Cooperative Oncology Group performance status 2-3
- Able to provide informed consent and complete trial assessments in available languages.
Who cannot join
- Blood cancers: Leukaemia, Lymphoma, Myelodysplastic Syndromes (MDS), Myeloproliferative Disorder (MPD), Multiple Myeloma.
- Currently receiving specialist rehabilitation* for their cancer or co-morbidity-related dysfunction, or received within the two weeks prior to consent.
- Clinician rated prognosis of less than 3 months.
Trial locations and contacts
11 sites in 5 countries.
11 sites in 5 countries
United Kingdom6 sites, 6 recruiting
- Not yet recruiting
Western General Hospital in Edinburgh
Edinburgh, 3H4 2XU
Barry Laird
- Not yet recruiting
St Gemma's Hospice
Leeds, LS17 6QD
Rachel Byrne
- Not yet recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 7EH
Gareth Jones
Nicola Peat
- Recruiting
King's College Hospital
London, SE5 9PJ
Matthew Maddocks
- Not yet recruiting
Worthing Hospital
Worthing, BN11 2DH
Kirsty Bracewell
- Not yet recruiting
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, YO31 8HE
Lucy Fettes
Italy2 sites, 2 recruiting
- Not yet recruiting
Istituto Nazionale dei Tumori di Milano
Milan, 20133
Augusto Caraceni
- Recruiting
AUSL di Reggio Emilia
Reggio Emilia, 42122
Stefania Costi
Denmark1 site, 1 recruiting
- Not yet recruiting
Herlev Hospital
Herlev, 2730
Inna Chen
France1 site, 1 recruiting
- Recruiting
Hôpital Lyon Sud HCL
Lyon, 69002
Guillaume Economos
Norway1 site, 1 recruiting
- Not yet recruiting
St Olav's Hospital
Trondheim, 7030
Line Oldervoll
About this study
Official title: Integrated Short-term Palliative Rehabilitation to Improve Quality of Life and Equitable Care Access in Incurable Cancer: A Multi-national Randomised Controlled Trial
The goal of this intervention trial is to determine if 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.
Read the detailed description
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, the investigators 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 the investigators plan to recruit 340 participants from hospitals. The investigators aim to find out if and how the rehabilitation intervention affects the participants who take part in the study. The investigators 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.
- st 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.
- nd rehabilitation will be scheduled around 4 weeks, but no later than 5 weeks after joining the trial.
- rd 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 Trial Manager: INSPIRE@kcl.ac.uk
- Conditions
- Cancer
- Being tested
- Integrated Short-term Palliative Rehabilitation
- Keywords
- cancer, Rehabilitation, palliative, support, disability
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Short-term Palliative RehabilitationOther
Participants will be offered up to 3 manualised sessions (face to face and/or remotely, via telephone or video-conference) delivered by an expert rehabilitation practitioner (physiotherapist, occupational therapist,).
Core components focus on (i) self-management of symptoms, (ii) physical activities and fitness, and (iii) social participation. Delivery of rehabilitation intervention components will include explicit use of behaviour change techniques including goal setting and action planning to focus on outcomes that are meaningful for the person, their family, and clinicians.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | Integrated Short-term Palliative Rehabilitation + usual care Receives: Other: Integrated Short-term Palliative Rehabilitation |
| control arm | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Assessed using Functional Assessment of Cancer Therapy (FACT-G) General scale, where high score indicates better functional well-being and quality of life for cancer patients. Lower scores may indicate a greater burden of symptoms, reduced ability to perform daily activities, and overall lower satisfaction with life during the cancer journey.
Measured: Assessed at 8 weeks after enrollment to the study
Secondary outcomes (5)
FACT-G: Assessed using Functional Assessment of Cancer Therapy - General
Functional Assessment of Cancer Therapy (FACT) General scale at 4 and 16 weeks, where high score indicates better functional well-being and quality of life for cancer patients. Lower scores may indicate a greater burden of symptoms, reduced ability to perform daily activities, and overall lower satisfaction with life during the cancer journey.
Measured: Assessed at 4 and 16 weeks after enrollment to the study
Disability - World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Higher scores reflect more significant disability, while lower scores indicate better functional status and less disability. It is used to measure and assess the impact of health conditions or disabilities on a participant's ability to function in their daily life.
Measured: Assessed at 8 and 16 weeks after enrollment to the study
Symptoms - Palliative Outcomes Scale
Symptoms- Palliative Outcomes Scale - Symptoms (POS-S): designed to evaluate the severity and impact of various symptoms on the participant's quality of life. Higher scores indicate more severe symptoms and a greater impact on the patient's well-being, while lower scores indicate milder symptoms and less disruption in daily life.
Measured: Assessed at 8 and 16 weeks after enrollment to the study
Goal attainment- Goal attainment scale (GAS-Light)
Goal attainment- Goal attainment scale (GAS-Light): is a tool used to measure the extent to which an participant has achieved specific goals or objectives.
Measured: Assessed at 8 and 16 weeks after enrollment to the study
Client Service Receipt Inventory
Client Service Receipt Inventory at 8 and 16 weeks
Measured: Assessed at 8 and 16 weeks after enrollment to the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start18 Apr 2024
- Primary completion2 Oct 2025 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multinational, parallel group, randomised, controlled, assessor blind, superiority trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon, University of Bergen, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Research Unit for General Practice, Aarhus University, University of Edinburgh, EAPC, Azienda USL Reggio Emilia - IRCCS
- Responsible party
- Sponsor
- Investigators
- Matthew Maddocks, Principal investigator, KCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984797
- Sponsor's protocol ID
- INSPIRE
- Other IDs
- 328722
- Acronym
- INSPIRE
- Status last verified
- May 2024
- First submitted
- 24 Jul 2023
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Short-term Palliative Rehabilitation to Improve Quality of Life and Equitable Care Access in Incurable Cancer: A Multi-national Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05984797
- Acronym / sponsor ID
- INSPIRE / INSPIRE
- Conditions
- Cancer
- Keywords
- cancer, Rehabilitation, palliative, support, disability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon, University of Bergen, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Research Unit for General Practice, Aarhus University, University of Edinburgh, EAPC, Azienda USL Reggio Emilia - IRCCS
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 2 Oct 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this intervention trial is to determine if 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.
Detailed description
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, the investigators 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 the investigators plan to recruit 340 participants from hospitals. The investigators aim to find out if and how the rehabilitation intervention affects the participants who take part in the study. The investigators 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.
- st 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.
- nd rehabilitation will be scheduled around 4 weeks, but no later than 5 weeks after joining the trial.
- rd 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 Trial Manager: INSPIRE@kcl.ac.uk
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multinational, parallel group, randomised, controlled, assessor blind, superiority trial
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Other: Integrated Short-term Palliative RehabilitationIntegrated Short-term Palliative Rehabilitation + usual care |
| control arm | No intervention | –usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older.
- Diagnosis of incurable solid cancer: lung, colorectal, breast, prostate or other, irrespective of timing in relation to any oncology or palliative care treatments
- Eastern Cooperative Oncology Group performance status 2-3
- Able to provide informed consent and complete trial assessments in available languages.
Key exclusion criteria (3 listed)
- Blood cancers: Leukaemia, Lymphoma, Myelodysplastic Syndromes (MDS), Myeloproliferative Disorder (MPD), Multiple Myeloma.
- Currently receiving specialist rehabilitation* for their cancer or co-morbidity-related dysfunction, or received within the two weeks prior to consent.
- Clinician rated prognosis of less than 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Short-term Palliative RehabilitationParticipants will be offered up to 3 manualised sessions (face to face and/or remotely, via telephone or video-conference) delivered by an expert rehabilitation practitioner (physiotherapist, occupational therapist,). Core components focus on (i) self-management of symptoms, (ii) physical activities and fitness, and (iii) social participation. Delivery of rehabilitation intervention components will include explicit use of behaviour change techniques including goal setting and action planning to focus on outcomes that are meaningful for the person, their family, and clinicians. | Other | intervention arm |
Primary outcome
Health related quality of life
Time frame: Assessed at 8 weeks after enrollment to the study
Assessed using Functional Assessment of Cancer Therapy (FACT-G) General scale, where high score indicates better functional well-being and quality of life for cancer patients. Lower scores may indicate a greater burden of symptoms, reduced ability to perform daily activities, and overall lower satisfaction with life during the cancer journey.
5 secondary outcomes
FACT-G: Assessed using Functional Assessment of Cancer Therapy - General
Time frame: Assessed at 4 and 16 weeks after enrollment to the study
Disability - World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Time frame: Assessed at 8 and 16 weeks after enrollment to the study
Symptoms - Palliative Outcomes Scale
Time frame: Assessed at 8 and 16 weeks after enrollment to the study
Goal attainment- Goal attainment scale (GAS-Light)
Time frame: Assessed at 8 and 16 weeks after enrollment to the study
Client Service Receipt Inventory
Time frame: Assessed at 8 and 16 weeks after enrollment to the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Maddocks principal investigator
KCL
11 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Short-term Palliative Rehabilitation in people with Cancer, run by King's College London at 11 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Italy, Denmark, France, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact INSPIRE Research Team (02078480532, INSPIRE@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (time frame: Assessed at 8 weeks after enrollment to the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.