Integrated rehabilitation for thoracic cancer

ISRCTN	ISRCTN92666109
DOI	https://doi.org/10.1186/ISRCTN92666109
Protocol serial number	35673
Sponsor	King's College London
Funder	National Institute for Health Research

Submission date: 29/01/2018
Registration date: 30/01/2018
Last edited: 12/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Ms Joanne Bayly
Scientific

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

ORCID ID	0000-0001-9478-8932
Phone	+44 207 848 5679
Email	joanne.bayly@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Treatment, Complex Intervention, Rehabilitation
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Short term integrated rehabilitation for people with thoracic cancer: A feasibility trial
Study objectives	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(s)	London South East Research Ethics Committee, 23/11/2017, ref: 17/LO/1871
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/05/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	60
Total final enrolment	54
Key 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
Key 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
Date of first enrolment	01/02/2018
Date of final enrolment	07/01/2019

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

King’s College Hospital (lead centre)

Denmark Hill
London
SE5 9RS
United Kingdom

Princess Royal University Hospital

Farnborough Common
Kent
BR6 8ND
United Kingdom

Guy's Hospital

Great Maze Pond
London
SE1 9RT
United Kingdom

St Thomas' Hospital

Westminster Bridge Road
London
SE1 7EH
United Kingdom

Nottingham City Hospital

Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Current IPD sharing statement as of 25/02/2020: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. _____ Previous IPD sharing statement: The data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2020	25/02/2020	Yes	No
HRA research summary			26/07/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 2	27/11/2017	12/08/2022	No	No

Additional files

ISRCTN92666109 PROTOCOL V2 27Nov2017.pdf: Protocol file

Editorial Notes

12/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
22/10/2021: Internal review.
25/02/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. The publication and dissemination plan was changed.