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