Clinical trial NCT05984797: Integrated Short-Term Palliative Rehabilitation in Incurable Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: cancer
Rehabilitation
palliative
support
disability
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Hospices Civils de Lyon
name: University of Bergen
name: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Research Unit for General Practice, Aarhus University
name: University of Edinburgh
name: EAPC
name: Azienda USL - IRCCS di Reggio Emilia
First posted: 2023-08-09
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multinational, parallel group, randomised, controlled, assessor blind, superiority trial
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Primary outcomes:
measure: Health related quality of life
timeFrame: Assessed at 8 weeks after enrollment to the study
Secondary outcomes:
measure: FACT-G: Assessed using Functional Assessment of Cancer Therapy - General
timeFrame: Assessed at 4 and 16 weeks after enrollment to the study
measure: Disability - World Health Organization Disability Assessment Schedule (WHODAS 2.0)
timeFrame: Assessed at 8 and 16 weeks after enrollment to the study
measure: Symptoms - Palliative Outcomes Scale
timeFrame: Assessed at 8 and 16 weeks after enrollment to the study
measure: Goal attainment- Goal attainment scale (GAS-Light)
timeFrame: Assessed at 8 and 16 weeks after enrollment to the study
measure: Client Service Receipt Inventory
timeFrame: Assessed at 8 and 16 weeks after enrollment to the study
Other outcomes:
measure: Acceptability - Acceptability of Intervention Measure (AIM) and bespoke questionnaire. *Participants randomised to the intervention arm only
timeFrame: Assessed within first 2 weeks and then at week 8 after enrollment to the study
measure: Appropriateness - Intervention Appropriateness Measure (IAM) and bespoke questionnaire. *Participants randomised to the intervention arm only
timeFrame: Assessed within first 2 weeks and then at week 8 after enrollment to the study
measure: Access - semi-structured qualitative interviews
timeFrame: Participants will be interviewed in their own language by a researcher at the inclusion site after completing the rehabilitations intervention and their consent obtained
measure: Bespoke Questionnaire. *Participants randomised to the intervention arm only
timeFrame: Assessed within first 2 weeks and then at week 8 after enrollment to the study
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Lyon
country: France
facility: Hôpital Lyon Sud HCL
city: Milan
country: Italy
facility: Istituto Nazionale dei Tumori di Milano
city: Reggio Emilia
country: Italy
facility: AUSL di Reggio Emilia
city: Trondheim
country: Norway
facility: St Olav's Hospital
city: Edinburgh
country: United Kingdom
facility: Western General Hospital in Edinburgh
city: Leeds
country: United Kingdom
facility: St Gemma's Hospice
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: King's College Hospital
city: Worthing
country: United Kingdom
facility: Worthing Hospital
city: York
country: United Kingdom
facility: York and Scarborough Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: KCL
name: Matthew Maddocks
role: PRINCIPAL_INVESTIGATOR
References: