Integrated Short-Term Palliative Rehabilitation in Incurable Cancer

Study Overview
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Brief Summary
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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
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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

Official Title
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Integrated Short-term Palliative Rehabilitation to Improve Quality of Life and Equitable Care Access in Incurable Cancer: A Multi-national Randomised Controlled Trial

Conditions
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Cancer

Intervention / Treatment
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* Other: Integrated Short-term Palliative Rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multinational, parallel group, randomised, controlled, assessor blind, superiority trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention arm<br>Integrated Short-term Palliative Rehabilitation + usual care | Other: Integrated Short-term Palliative Rehabilitation<br>* 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.<br>|
| No Intervention: control arm<br>usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed at 8 weeks after enrollment to the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Assessed at 8 and 16 weeks after enrollment to the study | 
| Client Service Receipt Inventory | Client Service Receipt Inventory at 8 and 16 weeks | Assessed at 8 and 16 weeks after enrollment to the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, Rehabilitation, palliative, support, disability