Integrated Short-Term Palliative Rehabilitation in Incurable Cancer

NCT05984797 | Recruiting DMC

• 2 other identifiers: INSPIRE328722
• Study Type: interventional
• Target: 340
• Locations: 5 countries
• Sites: 11

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.

Conditions

Cancer

Keywords

cancer; Rehabilitation; palliative; support; disability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• FACT-G: Assessed using Functional Assessment of Cancer Therapy - General

  Assessed at 4 and 16 weeks after enrollment to the study

• Disability - World Health Organization Disability Assessment Schedule (WHODAS 2.0)

  Assessed at 8 and 16 weeks after enrollment to the study

• Symptoms - Palliative Outcomes Scale

  Assessed at 8 and 16 weeks after enrollment to the study

• Goal attainment- Goal attainment scale (GAS-Light)

  Assessed at 8 and 16 weeks after enrollment to the study

• Client Service Receipt Inventory

  Assessed at 8 and 16 weeks after enrollment to the study

Other Outcomes (4)

• Acceptability - Acceptability of Intervention Measure (AIM) and bespoke questionnaire. *Participants randomised to the intervention arm only

  Assessed within first 2 weeks and then at week 8 after enrollment to the study

• Appropriateness - Intervention Appropriateness Measure (IAM) and bespoke questionnaire. *Participants randomised to the intervention arm only

  Assessed within first 2 weeks and then at week 8 after enrollment to the study

• Access - semi-structured qualitative interviews

  Participants will be interviewed in their own language by a researcher at the inclusion site after completing the rehabilitations intervention and their consent obtained

Study Arms (2)

intervention arm

EXPERIMENTAL

Integrated Short-term Palliative Rehabilitation + usual care

Other: Integrated Short-term Palliative Rehabilitation

control arm

NO INTERVENTION

usual care

Interventions

Integrated Short-term Palliative Rehabilitation OTHER

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.

intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (11)

Herlev Hospital

Herlev, 2730, Denmark

NOT YET RECRUITING

Hôpital Lyon Sud HCL

Lyon, 69002, France

RECRUITING

Istituto Nazionale dei Tumori di Milano

Milan, 20133, Italy

NOT YET RECRUITING

AUSL di Reggio Emilia

Reggio Emilia, 42122, Italy

RECRUITING

St Olav's Hospital

Trondheim, 7030, Norway

NOT YET RECRUITING

Western General Hospital in Edinburgh

Edinburgh, 3H4 2XU, United Kingdom

NOT YET RECRUITING

St Gemma's Hospice

Leeds, LS17 6QD, United Kingdom

NOT YET RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

NOT YET RECRUITING

King's College Hospital

London, SE5 9PJ, United Kingdom

RECRUITING

Worthing Hospital

Worthing, BN11 2DH, United Kingdom

NOT YET RECRUITING

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, YO31 8HE, United Kingdom

NOT YET RECRUITING

Related Links

• Study Website

MeSH Terms

Conditions

Neoplasms

Study Officials

• Matthew Maddocks

  KCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

INSPIRE Research Team

CONTACT

02078480532; INSPIRE@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multinational, parallel group, randomised, controlled, assessor blind, superiority trial

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 9, 2023
• Study Start: April 18, 2024
• Primary Completion: October 2, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Locations

IT (2); GB (6); FR (1); DK (1); NO (1)