Personalised Diet, Exercise and Emotional Support for Lung Cancer Patients Having Chemotherapy or Radiotherapy Treatment
Study Details
Study Description
Brief Summary
Background
The term 'prehabilitation' refers to a period of time before treatment and often includes diet, exercise and/or wellbeing plans to help patients through their cancer treatment. Prehabilitation has shown to benefit patients having surgery, but there is little research into its use in chemotherapy or radiotherapy.
The United Kingdom sees more deaths from lung cancer than any other cancer. 70-80% of lung cancer patients receive chemotherapy or radiotherapy treatment. Treatment side effects can have a significant impact on quality of life. Personalised prehabilitation can take into account the challenges patients face, helping patients through treatment.
Aim
To see if a personalised plan of diet, exercise and emotional support can be used in practice for patients having chemotherapy or radiotherapy treatment for lung cancer.
Methods
The study will involve lung cancer patients from Imperial College Healthcare NHS Trust who are:
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Over the age of 18 years old
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Have not had previous lung cancer surgery and
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Are about to start chemotherapy or radiotherapy treatment
The prehabilitation interventions will be based upon patient need and readiness, assessed using:
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A series of questionnaires
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An assessment of walking
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A measure of grip strength
These will be done prior to and at the middle and end of a patient's chemotherapy and/or radiotherapy treatment. Personalised goals will be agreed at each stage.
Throughout treatment, patients will be asked to keep a daily diary to record their symptoms, appetite, mobility and mood. The diary will also be used to monitor goal adherence.
Public involvement
Patients will be part of a study advisory group, helping with research design and dissemination e.g. with the presentation of findings to the lung cancer support group.
Dissemination
All patients will receive a written summary of findings. Results will be shared in a scientific journal and presented at relevant conferences. Patients will not be identifiable.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Background
Prehabilitation programmes are increasingly used before surgery to optimise outcomes. However, 55% of patients are treated non-surgically with chemotherapy or radiotherapy. Prehabilitation has potential to increase resilience to withstand anticipated treatment deconditioning, but few prehabilitation pathways exist in the non-surgical field.
This is particularly the case for lung cancer, where 70-80% of patients have non-surgical treatment without access to prehabilitation. United Kingdom deaths from lung cancer are higher than any other cancer and outcomes are poor, highlighting an unmet need.
Study design
This is a study to assess if a personalised plan of diet, exercise and emotional support can be used in practice for patients having chemotherapy or radiotherapy treatment for lung cancer.
To tackle the unmet need within the field of lung cancer, I have co-designed a personalised prehabilitation model with healthcare professionals and patients, informed by theory and evidence. It embodies personalised care with interventions stratified according to need and readiness. However, before I can trial it with lung cancer patients, there are key uncertainties that need to be resolved, including whether patients will sign up, engage and adhere to the prehabilitation interventions.
Methods
The study will involve lung cancer patients from Imperial College Healthcare National Health
Service (NHS) Trust who are:
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Over the age of 18 years old
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Have not had previous lung cancer surgery and
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Are about to start chemotherapy or radiotherapy treatment
Patients will be identified by a member of their direct clinical care team, which will be either their lung consultant or their Clinical Nurse Specialist (CNS) from the weekly lung cancer meeting and a referral will be sent to the research team.
A sample size of 30 patients over a 6-month recruitment period is suitable within the time frame of this study and is based upon a recommend sample size of 24 - 50 for a pilot study.
Each patient will receive a patient information sheet either in person or electronically via email depending on their preference. If they agree to participate, they will be asked to complete a written consent form either in person or via email using their personal computer. Following consent, each patient will be asked to complete five validated questionnaires, either on paper or online. The five questionnaires will take approximately 30 minutes to complete. These five questionnaires will be used to assess a patient's level of readiness and need.
Each patient will then be invited to see a specialist dietitian for a separate one hour face-to-face personalised prehabilitation appointment at Charing Cross Hospital to:
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Review the initial questionnaires
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Complete a further four validated questionnaires related to quality of life, diet and activity (= 9 questionnaires in total)
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Measure grip strength. This will involve a patient sitting in a chair. The dietitian will ask the patient to squeeze the device as hard as they can using their non-dominant arm. Each patient will repeat this three times and the dietitian will record the average
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Undergo an assessment of walking. This will involve a patient walking at their own pace as far as they can in 6 minutes
The above assessments will then be repeated at the middle and end (upon completion) of a patient's chemotherapy and/or radiotherapy treatment. Personalised goals will be agreed at each stage.
Owing to the nature of the above appointments and the need for measurements to be taken, a virtual consultation would not be practical.
Throughout treatment, patients will be asked to keep a daily diary to record their symptoms, appetite, mobility and mood. The diary will be given to patients by the research team at the start for the duration of the study. The research team will not need these to be sent back to them. Patients will receive a weekly telephone call to see how they are getting on. The language used during the phone calls and the face to face consultations is effective for building self-efficacy and to sustain behaviour change. Validation and compassion is at the core.
The personalised prehabilitation model is in line with the Macmillan universal, targeted and specialist approach for prehabilitation. All patients will receive universal interventions which involve signposting for support and/or information on emotional support, nutrition and/or exercise as required. If a patient identifies an emotional, nutritional and/or exercise need, they will then receive the appropriate intervention according to their level of need and readiness.
All patients who participate in the study will be offered the opportunity to provide feedback on their experience of the personalised prehabilitation model via the use of a short free text questionnaire. This feedback will be invaluable, as it will help inform future model adjustments and will have the potential to improve patient experience.
All patients will be given a unique study number that will be used from the start of the study. All data will be stored stored securely in accordance with the Trust policy on either a Trust computer, password protected, or under lock and key. Patient data will not be shared with parties outside of the patient's direct clinical care team or local research team.
The data will be analysed by the research team and all patients will receive a written summary of the findings. The results will be also be shared in scientific journals and conferences, so that others can learn from this as well. Patients will not be identifiable from any report or publication.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Personalised prehabilitation A personalised plan of diet, exercise and emotional support for patients having chemotherapy or radiotherapy treatment for lung cancer. |
Other: Assessment of level of readiness and need for personalised prehabilitation
Patients asked to complete five validated questionnaires to assess their level of need and readiness:
Cancer Behaviour Inventory brief form - to measure self-efficacy for coping with cancer
Patient Activation Measure - to measure patient activation
Modified Godin Leisure Time Exercise Questionnaire - to monitor activity
Patient Generated Subjective Global Assessment - to identify malnutrition risk
Emotions thermometer - to detect emotional disorders and identify risk
Other: Formation of a personalised prehabilitation plan
Prior to starting treatment, during the middle of treatment and immediately post treatment, each patient will be invited to see a specialist dietitian for a one hour face-to-face personalised prehabilitation appointment to:
Review the initial questionnaires to inform the personalised plan and goal setting
Complete a further four questionnaires related to quality of life, diet and exercise
Measure handgrip strength
Assess functional capacity by completing the six minute walk test
A personalised plan is then agreed using SMART goals, taking into account the patient's priorities as indicated in their Patient Generated Index.
Other: Daily diary
Each patient will be asked to keep a daily diary to record their symptoms, appetite, mobility and mood throughout their treatment as well as their adherence to goals. This will provide an indication of the impact of symptoms.
|
Outcome Measures
Primary Outcome Measures
- Evaluation of recruitment capability and sample characteristics [Immediately after chemotherapy or radiotherapy treatment]
Number of patients recruited
- Evaluation of recruitment capability and sample characteristics [Immediately after chemotherapy or radiotherapy treatment]
Number of patients who refused to take part
- Evaluation of recruitment capability and sample characteristics [Immediately after chemotherapy or radiotherapy treatment]
Identification of patient barriers to uptake assessed using a questionnaire
- Evaluation of recruitment capability and sample characteristics [Immediately after chemotherapy or radiotherapy treatment]
Length of time taken to recruit enough patients
- Evaluation of recruitment capability and sample characteristics [Immediately after chemotherapy or radiotherapy treatment]
Percentage of staff who thought that the eligibility criteria was feasible and suitable, assessed via a questionnaire
- Evaluation of recruitment capability and sample characteristics [Immediately after chemotherapy or radiotherapy treatment]
Length of time between diagnosis and start of treatment to assess the window of opportunity for prehabilitation
- Evaluation and refinement of data collection procedures and outcome measures [Immediately after chemotherapy or radiotherapy treatment]
Patients ability to complete the tools used by assessing the number of tools completed
- Evaluation and refinement of data collection procedures and outcome measures [Immediately after chemotherapy or radiotherapy treatment]
Appropriateness of data collection procedures and outcome measures by the number of tools completed
- Evaluation and refinement of data collection procedures and outcome measures [Immediately after chemotherapy or radiotherapy treatment]
Appropriateness of data collection procedures and outcome measures through patient feedback from the short free text questionnaire
- Evaluation and refinement of data collection procedures and outcome measures [Immediately after chemotherapy or radiotherapy treatment]
Percentage of staff who thought that the amount of data collected was feasible and suitable, assessed by a questionnaire
- Evaluation and refinement of data collection procedures and outcome measures [Immediately after chemotherapy or radiotherapy treatment]
Percentage of patients who thought that the amount of data collected was feasible and suitable, assessed by a questionnaire
- Evaluation and refinement of data collection procedures and outcome measures [Immediately after chemotherapy or radiotherapy treatment]
Percentage of patients who complete the tools accurately, assessed via tool completion rate
- Evaluation of acceptability and suitability of intervention and study procedures [Immediately after chemotherapy or radiotherapy treatment]
Attrition rate
- Evaluation of acceptability and suitability of intervention and study procedures [Immediately after chemotherapy or radiotherapy treatment]
Adherence to using a daily diary assessed by completion of the diary
- Evaluation of acceptability and suitability of intervention and study procedures [Immediately after chemotherapy or radiotherapy treatment]
Duration of the study assessed by patient feedback using the short free text questionnaire
- Evaluation of acceptability and suitability of intervention and study procedures [Immediately after chemotherapy or radiotherapy treatment]
Percentage of patients who thought that the tools used were suitable, assessed via a questionnaire
- Evaluation of acceptability and suitability of intervention and study procedures [Immediately after chemotherapy or radiotherapy treatment]
Percentage of patients who would prefer a face to face mode of delivery compared to a virtual platform, assessed using a questionnaire
- Preliminary evaluation of participant responses to intervention [Baseline; pre-treatment and immediately after chemotherapy or radiotherapy treatment]
Incidence of change in outcome variables between baseline and immediately after treatment, assessed using descriptive statistics
- Preliminary evaluation of participant responses to intervention [Immediately after chemotherapy or radiotherapy treatment]
Number of patients who require universal, targeted and specialist interventions
Secondary Outcome Measures
- Quality of life assessed using the Patient Generated Index (PGI) [Baseline; pre-treatment, during treatment and immediately after treatment]
Incidence of change between baseline and immediately after treatment assessed by any differences in PGI
- Quality of life assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQC30 questionnaire [Baseline; pre-treatment, during treatment and immediately after treatment]
Incidence of change between baseline and immediately after treatment assessed by any differences in the EORTC questionnaire
- Quality of life assessed using the EuroQOL Group EQ-5D-5L questionnaire [Baseline; pre-treatment, during treatment and immediately after treatment]
Incidence of change between baseline and immediately after treatment assessed by any differences in the EQ-5D-5L questionnaire
- Patient experience [Immediately after chemotherapy or radiotherapy treatment]
Assessed via a short free text questionnaire. Patients will be able to openly give written feedback on their experience and offer any comments or suggestions
- Impact of disease symptoms [During treatment]
Use of a daily diary to record symptoms, appetite, mobility and mood to assess the impact of disease symptoms
- Functional capacity [Baseline; pre-treatment, during treatment and immediately after treatment]
Patients to undertake a six minute walk test
- Physical activity levels [Baseline; pre-treatment, during treatment and immediately after treatment]
Patients to complete the Modified Godin Leisure Time Exercise Questionnaire. A higher score would indicate that a patient is more active
- Nutrition [Baseline; pre-treatment, during treatment and immediately after treatment]
Patients to complete the Patient Generated Subjective Global Assessment. Minimum value: 0. Maximum value: greater than 9. A score of 4 or greater would indicate that a patient is malnourished
- Handgrip strength [Baseline; pre-treatment, during treatment and immediately after treatment]
Use of a handgrip dynamometer to measure grip strength
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults (aged ≥ 18 years) diagnosed with lung cancer
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Able to give informed consent
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Due to embark on a chemotherapy and/or radiotherapy treatment pathway
Exclusion Criteria:
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On a surgical pathway
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Have had previous lung cancer surgery
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Unable to understand verbal or written English
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Unable to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Imperial College Healthcare NHS Trust | London | United Kingdom | W6 8RF |
Sponsors and Collaborators
- Imperial College Healthcare NHS Trust
Investigators
- Principal Investigator: Kelly Wade-Mcbane, Imperial College Healthcare NHS Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22CX7570