Condition category
Cancer
Date applied
29/01/2018
Date assigned
30/01/2018
Last edited
30/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
At any one time, over 65,000 people are alive in the UK having been given a lung cancer diagnosis. The condition and its medical treatment (with chemotherapy, radiotherapy and surgery) cause many symptoms that affect day-to-day life. These include breathlessness, weakness and tiredness or fatigue. Rehabilitation treatments can help to relieve these symptoms and can help people to stay active and independent whilst living with lung cancer. Most research studies to date have offered rehabilitation in the form of supervised exercise programmes. These involve vigorous physical training, over several months, and often take place in a hospital setting, so require a lot of commitment from the person with cancer. Many people do not feel able to take part in these intensive programmes and miss out on rehabilitation. The aim of this project is test a different form of rehabilitation service, which may help more people to access and benefit from rehabilitation.

Who can participate?
Adults who have been recently diagnosed with lung cancer or pleural mesothelioma.

What does the study involve?
Participants are offered the rehabilitation service close to the time when they are diagnosed to help them prepare for medical treatments and stay active. This is delivered by a specialist physiotherapist and is short-term so the person can benefit from advice and education quickly and does not have to sign up to a long programme. It is delivered alongside the care other health professions provide for the person with cancer, such as their cancer doctor or nurse. People recently diagnosed with lung cancer are randomly allocated to receive the rehabilitation service or usual care. People allocated to receive the service have three contacts with the physiotherapist. These are discuss symptom and problems that are limiting their daily living, to learn about ways to self-manage these, and to develop an action plan to encourage good health behaviours, such as staying active by pacing daily tasks. We Markers of how well the research study went, including how many people took part, their experiences of the research and the extent to which people receive the care they were allocated to are measured. Symptom distress, physical activity levels, functional ability and quality of life before and after the service (or usual care) are assessed.

What are the possible benefits and risks of participating?
The trial is designed to understand if short-term rehabilitation can benefit people with lung cancer or mesothelioma. We don’t know if it will benefit people but the information we get from this trial will help improve the future treatment of people with lung cancer or mesothelioma. It is a very low risk trial. Rehabilitation is tolerated by people with a wide range of health conditions. The rehabilitation will be tailored to each person’s needs and capability. Some people may benefit from the rehabilitation but it is possible other people will not benefit from rehabilitation.

Where is the study run from?
Kings College London (UK)

When is the study starting and how long is it expected to run for?
May 2015 to May 2019

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Jo Bayly (Scientific)
joanne.bayly@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Joanne Bayly

ORCID ID

http://orcid.org/0000-0001-9478-8932

Contact details

Cicely Saunders Institute of Palliative Care
Policy and Rehabilitation
Florence Nightingale Faculty of Nursing
Midwifery & Palliative Care
King’s College London
Bessemer Road
London
SE5 9PJ
United Kingdom
+44 207 848 5679
joanne.bayly@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35673

Study information

Scientific title

Short term integrated rehabilitation for people with thoracic cancer: A feasibility trial

Acronym

Study hypothesis

This is a study to find out if people who have recently been diagnosed with lung cancer or mesothelioma are willing to participate in a short rehabilitation programme.

Ethics approval

London South East Research Ethics Committee, 23/11/2017, ref: 17/LO/1871

Study design

Randomised; Interventional; Design type: Treatment, Complex Intervention, Rehabilitation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Cancer, Primary sub-specialty: Palliative and supportive care; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs

Intervention

This study is testing the feasibility of a short term rehabilitation service for patients who have been diagnosed with either lung cancer or pleural mesothelioma within the last 8 weeks.

Participants are randomly allocated to one of two groups.

One group receives standard care as usual.

One group receives standard care plus a short term rehabilitation service. This involves up to three sessions with a physiotherapist in either the hospital or home setting.

Key components of the service include:
1. Checking patient’s understanding and beliefs about their illness, their concerns and treatment goals
2. Screening how well they are functioning in daily life
3. Information and strategies to support self-management
4. Help for patient and family to anticipate and manage future situations, e.g. deterioration
5. A rehabilitation action plan, integrated follow up and onward referral to existing services

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The primary aim of this study is to establish the feasibility of a future definitive trial; as such it’s aims are:
1. To inform the recruitment, sample size and timeline of a future fully-powered trial, by establishing the number of participants identified, approached, consented, randomised and completed over the trial period and the rate of recruitment per month.
2. To inform future trial procedures by establishing the acceptability and experience of the trial processes to participants; including randomisation, the proportion of randomised patients remaining on trial for 30 and 60 days, the number of physiotherapy contacts received and reasons for drop out.
3. To refine future trial procedures by establishing response and completion rates for each trial outcome at baseline, 30 and 60 days, summarised overall and by trial arm.
4. To further assess the acceptability of the trial procedures by evaluating treatment fidelity and contamination using number of planned contacts per participant, number of patients seen with carer and mode of contact, the proportion of patients with a rehabilitation plan.
5. To further assess the acceptability of the intervention by evaluating the uptake of discreet components: i. self-management of symptoms, ii. maintain physical activity and fitness, iii. maintain task performance and participation in activities, iv. onward referral to other services by treatment arm.

Secondary outcome measures

The self-reported outcome measures that will be evaluated within this feasibility study are as follows:
1. Symptom levels, measured using the Integrated Palliative Care Outcome Scale (iPOS) completed at baseline and 30 and 60 days post baseline.
2. Physical activity levels, measured using the Physical Activity Scale for the Elderly (PASE).
3. Confidence and self-efficacy to manage the impact of illness and treatment, measured using the Self-efficacy measure for chronic disease (SEMCD).
4. Health-Related Quality of life, measured using the Functional Assessment of Cancer Therapy- Lung (FACT-L) and the FACT-L Trial Outcome Index (FACT-L TOI) and the EuroQol 5-Dimension 5 Level (EQ-5D-5L).
5. Participant’s recent health service use will be measured using the Client Service Receipt Inventory (CSRI).
6. Participants experience of receiving the trial rehabilitation intervention, measured using the Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction – Patient Satisfaction (FACIT-TS=PS).
7. Experience of participating in the trial will be evaluated in both arms using questions from the National Institute of Health Research Clinical Research Network Coordinating Centre Patient Research Experience Questionnaire.

Overall trial start date

19/05/2015

Overall trial end date

31/05/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age >18 years
2. Clinical or histological diagnosis of NSCLC, SCLC or MPM, within the last 8 weeks
3. ECOG performance status 0-3
4. Ability to respond to questions in written English – or availability of interpreters to enable this

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Co-existing progressive neurological condition (e.g. multiple sclerosis, motor neurone disease)
2. ECOG performance status 4(due to association with short survival)
3. Inability to complete patient questionnaires due to cognitive impairment, or language difficulties and lack of interpreters
4. Patients currently receiving specialist rehabilitation, or planned to receive within the next month
5. Receiving palliative care with expectation of death within 1 month

Recruitment start date

01/02/2018

Recruitment end date

07/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King’s College Hospital (lead centre)
Denmark Hill
London
SE5 9RS
United Kingdom

Trial participating centre

Princess Royal University Hospital
Farnborough Common
Kent
BR6 8ND
United Kingdom

Trial participating centre

Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom

Trial participating centre

St Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Director of Research Management & Director of Administration (Health Schools)
Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer review journal within one year of trial end date. Planned dissemination via presentation at an International Oncology Conference and via the NIHR South London Collaboration for Leadership in Applied Health Research and Care (South London CLAHRC) within one year of trial end date.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes