Integrated Short-Term Palliative Rehabilitation in Incurable Cancer

Cancer Clinical Trial

— INSPIRE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05984797
• Other study ID #: INSPIRE
• Secondary ID: 328722
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: King's College London
• Contact: INSPIRE Research Team
• Phone: 02078480532
• Email: INSPIRE[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: August 31, 2026
• Est. primary completion date: October 2, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Integrated Short-term Palliative Rehabilitation
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.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev
France	Hôpital Lyon Sud HCL	Lyon
Italy	Istituto Nazionale dei Tumori di Milano	Milan
Italy	AUSL di Reggio Emilia	Reggio Emilia
Norway	St Olav's Hospital	Trondheim
United Kingdom	Western General Hospital in Edinburgh	Edinburgh
United Kingdom	St Gemma's Hospice	Leeds
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	King's College Hospital	London
United Kingdom	Worthing Hospital	Worthing
United Kingdom	York and Scarborough Teaching Hospitals NHS Foundation Trust	York

Sponsors (8)

Lead Sponsor	Collaborator
King's College London	Azienda USL - IRCCS di Reggio Emilia, EAPC, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Hospices Civils de Lyon, Research Unit for General Practice, Aarhus University, University of Bergen, University of Edinburgh

Countries where clinical trial is conducted

Denmark,  France,  Italy,  Norway,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability - Acceptability of Intervention Measure (AIM) and bespoke questionnaire. *Participants randomised to the intervention arm only	Acceptability of Intervention Measure (AIM) is a 4-item scale that measures the perception of satisfaction and agreeability of an intervention. Items are rated using a Likert-type semantic differential scale, ranging from 1 to 5. The AIM has a Cronbach's alpha of 0.85	Assessed within first 2 weeks and then at week 8 after enrollment to the study
Other	Appropriateness - Intervention Appropriateness Measure (IAM) and bespoke questionnaire. *Participants randomised to the intervention arm only	The Intervention Appropriateness Measure (IAM), a 4-item scale measuring the perceived relevance and compatibility of the intervention. Items are rated using a Likert-type semantic differential scale, ranging from 1 to 5. The IAM has a Cronbach's alpha of 0.91	Assessed within first 2 weeks and then at week 8 after enrollment to the study
Other	Access - semi-structured qualitative interviews	Qualitative interviews will be conducted to assess the acceptability and the appropriateness of the intervention from the patients' point of view. These will allow patients to offer their opinion and feelings about the intervention, to identify convergences and divergences between the quantitative and qualitative parts, and finally to deepen our implementation evaluation of the acceptability and appropriateness aspects.	Participants will be interviewed in their own language by a researcher at the inclusion site after completing the rehabilitations intervention and their consent obtained
Other	Bespoke Questionnaire. *Participants randomised to the intervention arm only	A bespoke quantitative questionnaire was designed using adapted items from our literature review of published implementation questionnaires (https://implementationoutcomerepository.org/), rated based on a semantic differential scale (Likert-type), to fit with the ratings used for AIM and IAM	Assessed within first 2 weeks and then at week 8 after enrollment to the study
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Client Service Receipt Inventory	Client Service Receipt Inventory at 8 and 16 weeks	Assessed at 8 and 16 weeks after enrollment to the study

External Links

•   Study Website