Trial Title:
Integrated Short-Term Palliative Rehabilitation in Incurable Cancer
NCT ID:
NCT05984797
Condition:
Cancer
Conditions: Keywords:
cancer
Rehabilitation
palliative
support
disability
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Multinational, parallel group, randomised, controlled, assessor blind, superiority trial
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
Owing to the nature of the intervention, it is not possible to blind participants or
intervention practitioners. Individual participants are allocated on a 1:1 basis to
receive either palliative rehabilitation plus usual care or usual care. Treatment
allocation will not be disclosed to the CTRU KCTU trial team or to other members of the
research teams involved in data analysis to maintain blinding during outcome assessment
and to minimise possible bias. Individual participants are allocated on a 1:1 basis to
receive either palliative rehabilitation plus usual care or usual care. A
computer-generated minimisation programme that incorporates a random element will be used
to ensure that treatment groups are well balanced for: trial country ,baseline FACT-G
score (<=64, 65-79, 80+), ECOG performance status (2, 3) in order to guard against chance
bias in patient allocation for prognostic factors.
Intervention:
Intervention type:
Other
Intervention name:
Integrated Short-term Palliative Rehabilitation
Description:
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.
Arm group label:
intervention arm
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.
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.
1. 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.
2. nd rehabilitation will be scheduled around 4 weeks, but no later than 5 weeks after
joining the trial.
3. 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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Herlev Hospital
Address:
City:
Herlev
Zip:
2730
Country:
Denmark
Status:
Not yet recruiting
Investigator:
Last name:
Inna Chen
Email:
Principal Investigator
Facility:
Name:
Hôpital Lyon Sud HCL
Address:
City:
Lyon
Zip:
69002
Country:
France
Status:
Recruiting
Investigator:
Last name:
Guillaume Economos
Email:
Principal Investigator
Facility:
Name:
Istituto Nazionale dei Tumori di Milano
Address:
City:
Milan
Zip:
20133
Country:
Italy
Status:
Not yet recruiting
Investigator:
Last name:
Augusto Caraceni
Email:
Principal Investigator
Facility:
Name:
AUSL di Reggio Emilia
Address:
City:
Reggio Emilia
Zip:
42122
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Stefania Costi
Email:
Principal Investigator
Facility:
Name:
St Olav's Hospital
Address:
City:
Trondheim
Zip:
7030
Country:
Norway
Status:
Not yet recruiting
Investigator:
Last name:
Line Oldervoll
Email:
Principal Investigator
Facility:
Name:
Western General Hospital in Edinburgh
Address:
City:
Edinburgh
Zip:
3H4 2XU
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Barry Laird
Email:
Principal Investigator
Facility:
Name:
St Gemma's Hospice
Address:
City:
Leeds
Zip:
LS17 6QD
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Rachel Byrne
Email:
Principal Investigator
Facility:
Name:
Guy's and St Thomas' NHS Foundation Trust
Address:
City:
London
Zip:
SE1 7EH
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Gareth Jones
Email:
Principal Investigator
Investigator:
Last name:
Nicola Peat
Email:
Sub-Investigator
Facility:
Name:
King's College Hospital
Address:
City:
London
Zip:
SE5 9PJ
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Matthew Maddocks
Email:
Principal Investigator
Facility:
Name:
Worthing Hospital
Address:
City:
Worthing
Zip:
BN11 2DH
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Kirsty Bracewell
Email:
Principal Investigator
Facility:
Name:
York and Scarborough Teaching Hospitals NHS Foundation Trust
Address:
City:
York
Zip:
YO31 8HE
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Lucy Fettes
Email:
Principal Investigator
Start date:
April 18, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
King's College London
Agency class:
Other
Collaborator:
Agency:
Hospices Civils de Lyon
Agency class:
Other
Collaborator:
Agency:
University of Bergen
Agency class:
Other
Collaborator:
Agency:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class:
Other
Collaborator:
Agency:
Research Unit for General Practice, Aarhus University
Agency class:
Other
Collaborator:
Agency:
University of Edinburgh
Agency class:
Other
Collaborator:
Agency:
EAPC
Agency class:
Other
Collaborator:
Agency:
Azienda USL - IRCCS di Reggio Emilia
Agency class:
Other
Source:
King's College London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984797
https://palliativeprojects.eu/inspire/
