Specialty: Cancer, Primary sub-specialty: Palliative and supportive care
Conditions
Interventions
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.
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Outcome results
None listed