Lung CancerNCT05318807
Personalised Diet, Exercise and Emotional Support for Lung Cancer Patients Having Chemotherapy, Radiotherapy or Immunotherapy Treatment
A study testing Assessment of level of readiness and need for personalised prehabilitation, Formation of a personalised prehabilitation plan and Daily diary in people with Lung Cancer, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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 the oncological setting. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Assessment of level of readiness and need for personalised prehabilitation, Formation of a personalised prehabilitation plan and Daily diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Oct 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged ≥ 18 years) diagnosed with lung cancer
- Able to give informed consent
- Due to embark on a chemotherapy, radiotherapy and/or immunotherapy treatment pathway
Who cannot join
- On a surgical pathway
- Have had previous lung cancer surgery
- Unable to understand verbal or written English
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W6 8RF
Kelly Wade-Mcbane, 0203 311 7135, k.wade-mcbane@nhs.net
About this study
Official title: A Personalised Prehabilitation Model for Patients Undergoing Chemotherapy, Radiotherapy and/or Immunotherapy Treatment for Lung Cancer: A Feasibility Pilot Study
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 the oncological setting.
Read more
The United Kingdom sees more deaths from lung cancer than any other cancer. 70-80% of lung cancer patients receive oncological 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, radiotherapy and/or immunotherapy treatment for lung cancer.
Methods
The study will involve lung cancer patients from Imperial College Healthcare NHS Trust who are:
- Over the age of 18 years old
- Have not had previous lung cancer surgery and
- Are about to start chemotherapy, radiotherapy or immunotherapy treatment
The prehabilitation interventions will be based upon patient need and readiness, assessed using:
- A series of questionnaires
- An assessment of walking
- A measure of grip strength
These will be done prior to, at week three and at week six of a patient's oncological treatment regime. 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.
Read the detailed description
Background
Prehabilitation programmes are increasingly used before surgery to optimise outcomes. However, 55% of patients are treated non-surgically with oncological treatment. 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, radiotherapy and/or immunotherapy 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:
- Over the age of 18 years old
- Have not had previous lung cancer surgery and
- 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:
- Review the initial questionnaires
- Complete a further four validated questionnaires related to quality of life, diet and activity (= 9 questionnaires in total)
- 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
- 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 week three and week six of a patients oncological treatment regime. 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.
- Conditions
- Lung Cancer
- Being tested
- Assessment of level of readiness and need for personalised prehabilitation, Formation of a personalised prehabilitation plan, Daily diary
- Keywords
- prehabilitation, radiotherapy, chemotherapy, feasibility, immunotherapy, nutrition, physical activity, psychological wellbeing
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of level of readiness and need for personalised prehabilitationOther
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
Formation of a personalised prehabilitation planOther
Prior to starting treatment, at week three and at week six, 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.
Daily diaryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalised prehabilitation | Experimental | A personalised plan of diet, exercise and emotional support for patients having chemotherapy, radiotherapy and/or immunotherapy treatment for lung cancer. Receives: Other: Assessment of level of readiness and need for personalised prehabilitation; Other: Formation of a personalised prehabilitation plan; Other: Daily diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasible eligibility, recruitment and refusal rates
Use of descriptive statistics - number approached, eligible, recruited, refused
Measured: Immediately after week six of oncological treatment
How many participants do not participate in the personalised prehabilitation programme and explore the reasons why
Use of descriptive statistics, field notes taken during the Lung Cancer Multi-Disciplinary Team (LCMDT) and participant discussion
Measured: Immediately after week six of oncological treatment
Number of participants who are not suitable for the personalised prehabilitation programme and the reasons why
Use of descriptive statistics and field notes taken during the LCMDT, where discussions of eligibility will take place
Measured: Immediately after week six of oncological treatment
Attrition rate throughout the personalised prehabilitation programme
Use of descriptive statistics - number who drop out and at what stage
Measured: Immediately after week six of oncological treatment
Number of participants who adhere to the goals set for the personalised prehabilitation interventions
Adherence to goals set measured through participant discussion at the weekly telephone consultations
Measured: Immediately after week six of oncological treatment
Barriers and facilitators to adherence and intervention fidelity
Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of the emotion thermometer questionnaire used for the personalised prehabilitation programme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of the modified Godin leisure time exercise questionnaire used for the personalised prehabilitation programme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of the patient generated subjective global assessment questionnaire used for the personalised prehabilitation programme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of the patient activation measure questionnaire used for the personalised prehabilitation programme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of the cancer behaviour inventory questionnaire used for the personalised prehabilitation programme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of the patient generated index used for the personalised prehabilitation programme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of measuring body weight in kilograms for the personalised prehabilitation progamme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of measuring functional capacity by the distance covered in meters using the six minute walk test as part of the personalised prehabilitation programme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of participant acceptability of measuring grip strength in kilograms using a handgrip dynamometer as part of the personalised prehabilitation programme
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of contextual or implementation factors which may influence acceptability of the intervention/s
Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations; participant reflection, participant needs and priorities, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Evaluation of contextual or implementation factors which may influence effectiveness of the intervention/s
Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations; participant reflection, participant needs and priorities, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
The 'prehabilitation window' (length of time between diagnosis and the start of treatment)
Use of descriptive statistics - date of diagnosis, date of start of treatment, date of start and finish of prehabilitation
Measured: Immediately after week six of oncological treatment
The extent to which the prehabilitation programme has had an impact on psychological wellbeing
Use of the emotional thermometer questionnaire which will be used to assess psychological wellbeing - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
The extent to which the prehabilitation programme has had an impact on nutrition
Use of the Patient Generated Subjective Global Assessment (PG-SGA) tool which will be used to assess nutritional status - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
The extent to which the prehabilitation programme has had an impact on physical activity
Use of the Modified Godin leisure time exercise questionnaire which will be used to assess physical activity - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Measured: Immediately after week six of oncological treatment
Number of participants who require universal, targeted and specialist intervention
Use of questionnaires to assess level of need and readiness and descriptive statistics
Measured: Immediately after week six of oncological treatment
Secondary outcomes (5)
Quality of life assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQC30 questionnaire
Incidence of change between baseline and immediately after treatment assessed by any differences in the EORTC questionnaire
Measured: Baseline; pre-treatment, during treatment and immediately after treatment
Quality of life assessed using the EuroQOL Group EQ-5D-5L questionnaire
Incidence of change between baseline and immediately after treatment assessed by any differences in the EQ-5D-5L questionnaire
Measured: Baseline; pre-treatment, during treatment and immediately after treatment
Patient experience
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
Measured: Immediately after week six of oncological treatment
Functional capacity
Assessed by patients undertaking a six minute walk test
Measured: Baseline; pre-treatment, during treatment and immediately after treatment
Handgrip strength
Assessed using a handgrip dynamometer to measure grip strength
Measured: Baseline; pre-treatment, during treatment and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start28 Oct 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Wade-Mcbane, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318807
- Sponsor's protocol ID
- 22CX7570
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants will be given a unique study number that will be used from the start of the study. Files (e.g. paper consent forms and questionnaires) will be stored in research offices and secured by either lock and key or key code and accessible by only departmental staff or the Trust's security department. Personal data (e.g. patient demographics and results of assessments) will be retained and stored on a networked and password protected NHS computer. Patient data will not be shared with parties outside of the patient's direct clinical care team or local research team. Stored data will be pseudonymised at the time of collection/storage. Data will be collected according to the data protection act 2018 and in line with general data Protection regulation GDPR). Results will be shared in a scientific journal and presented at relevant conferences. Patients will not be identifiable.
Publications
Wade-Mcbane K, King A, Urch C, Johansson L, Wells M. Is personalised prehabilitation feasible to implement for patients undergoing oncological treatment for lung cancer at a London teaching hospital? Protocol of a feasibility trial. BMJ Open. 2023 Jul 17;13(7):e072367. doi: 10.1136/bmjopen-2023-072367.
PubMed 37460263
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Personalised Prehabilitation Model for Patients Undergoing Chemotherapy, Radiotherapy and/or Immunotherapy Treatment for Lung Cancer: A Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT05318807
- Acronym / sponsor ID
- 22CX7570
- Conditions
- Lung Cancer
- Keywords
- prehabilitation, radiotherapy, chemotherapy, feasibility, immunotherapy, nutrition, physical activity, psychological wellbeing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 the oncological setting.
The United Kingdom sees more deaths from lung cancer than any other cancer. 70-80% of lung cancer patients receive oncological 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, radiotherapy and/or immunotherapy treatment for lung cancer.
Methods
The study will involve lung cancer patients from Imperial College Healthcare NHS Trust who are:
- Over the age of 18 years old
- Have not had previous lung cancer surgery and
- Are about to start chemotherapy, radiotherapy or immunotherapy treatment
The prehabilitation interventions will be based upon patient need and readiness, assessed using:
- A series of questionnaires
- An assessment of walking
- A measure of grip strength
These will be done prior to, at week three and at week six of a patient's oncological treatment regime. 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.
Detailed description
Background
Prehabilitation programmes are increasingly used before surgery to optimise outcomes. However, 55% of patients are treated non-surgically with oncological treatment. 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, radiotherapy and/or immunotherapy 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:
- Over the age of 18 years old
- Have not had previous lung cancer surgery and
- 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:
- Review the initial questionnaires
- Complete a further four validated questionnaires related to quality of life, diet and activity (= 9 questionnaires in total)
- 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
- 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 week three and week six of a patients oncological treatment regime. 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility pilot study
| Arm | Type | Receives |
|---|---|---|
| Personalised prehabilitation | Experimental | Other: Assessment of level of readiness and need for personalised prehabilitation, Other: Formation of a personalised prehabilitation plan, Other: Daily diaryA personalised plan of diet, exercise and emotional support for patients having chemotherapy, radiotherapy and/or immunotherapy treatment for lung cancer. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (aged ≥ 18 years) diagnosed with lung cancer
- Able to give informed consent
- Due to embark on a chemotherapy, radiotherapy and/or immunotherapy treatment pathway
Key exclusion criteria (4 listed)
- On a surgical pathway
- Have had previous lung cancer surgery
- Unable to understand verbal or written English
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of level of readiness and need for personalised prehabilitationPatients asked to complete five validated questionnaires to assess their level of need and readiness: 1. Cancer Behaviour Inventory brief form - to measure self-efficacy for coping with cancer 2. Patient Activation Measure - to measure patient activation 3. Modified Godin Leisure Time Exercise Questionnaire - to monitor activity 4. Patient Generated Subjective Global Assessment - to identify malnutrition risk 5. Emotions thermometer - to detect emotional disorders and identify risk | Other | Personalised prehabilitation |
| Formation of a personalised prehabilitation planPrior to starting treatment, at week three and at week six, 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 | Personalised prehabilitation |
| Daily diaryEach 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. | Other | Personalised prehabilitation |
Primary outcome
Feasible eligibility, recruitment and refusal rates
Time frame: Immediately after week six of oncological treatment
Use of descriptive statistics - number approached, eligible, recruited, refused
How many participants do not participate in the personalised prehabilitation programme and explore the reasons why
Time frame: Immediately after week six of oncological treatment
Use of descriptive statistics, field notes taken during the Lung Cancer Multi-Disciplinary Team (LCMDT) and participant discussion
Number of participants who are not suitable for the personalised prehabilitation programme and the reasons why
Time frame: Immediately after week six of oncological treatment
Use of descriptive statistics and field notes taken during the LCMDT, where discussions of eligibility will take place
Attrition rate throughout the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Use of descriptive statistics - number who drop out and at what stage
Number of participants who adhere to the goals set for the personalised prehabilitation interventions
Time frame: Immediately after week six of oncological treatment
Adherence to goals set measured through participant discussion at the weekly telephone consultations
Barriers and facilitators to adherence and intervention fidelity
Time frame: Immediately after week six of oncological treatment
Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of the emotion thermometer questionnaire used for the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of the modified Godin leisure time exercise questionnaire used for the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of the patient generated subjective global assessment questionnaire used for the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of the patient activation measure questionnaire used for the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of the cancer behaviour inventory questionnaire used for the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of the patient generated index used for the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of measuring body weight in kilograms for the personalised prehabilitation progamme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of measuring functional capacity by the distance covered in meters using the six minute walk test as part of the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of participant acceptability of measuring grip strength in kilograms using a handgrip dynamometer as part of the personalised prehabilitation programme
Time frame: Immediately after week six of oncological treatment
Completion rates, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Evaluation of contextual or implementation factors which may influence acceptability of the intervention/s
Time frame: Immediately after week six of oncological treatment
Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations; participant reflection, participant needs and priorities, short free text questionnaire at the end of the study, analysed thematically
Evaluation of contextual or implementation factors which may influence effectiveness of the intervention/s
Time frame: Immediately after week six of oncological treatment
Use of a daily diary - symptom log, discussions had with participants during the weekly telephone consultations; participant reflection, participant needs and priorities, short free text questionnaire at the end of the study, analysed thematically
The 'prehabilitation window' (length of time between diagnosis and the start of treatment)
Time frame: Immediately after week six of oncological treatment
Use of descriptive statistics - date of diagnosis, date of start of treatment, date of start and finish of prehabilitation
The extent to which the prehabilitation programme has had an impact on psychological wellbeing
Time frame: Immediately after week six of oncological treatment
Use of the emotional thermometer questionnaire which will be used to assess psychological wellbeing - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
The extent to which the prehabilitation programme has had an impact on nutrition
Time frame: Immediately after week six of oncological treatment
Use of the Patient Generated Subjective Global Assessment (PG-SGA) tool which will be used to assess nutritional status - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
The extent to which the prehabilitation programme has had an impact on physical activity
Time frame: Immediately after week six of oncological treatment
Use of the Modified Godin leisure time exercise questionnaire which will be used to assess physical activity - change between baseline and follow up, daily diary - symptom log, discussions had with participants during the weekly telephone consultations, short free text questionnaire at the end of the study, analysed thematically
Number of participants who require universal, targeted and specialist intervention
Time frame: Immediately after week six of oncological treatment
Use of questionnaires to assess level of need and readiness and descriptive statistics
5 secondary outcomes
Quality of life assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQC30 questionnaire
Time frame: Baseline; pre-treatment, during treatment and immediately after treatment
Quality of life assessed using the EuroQOL Group EQ-5D-5L questionnaire
Time frame: Baseline; pre-treatment, during treatment and immediately after treatment
Patient experience
Time frame: Immediately after week six of oncological treatment
Functional capacity
Time frame: Baseline; pre-treatment, during treatment and immediately after treatment
Handgrip strength
Time frame: Baseline; pre-treatment, during treatment and immediately after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 37460263Wade-Mcbane K, King A, Urch C, Johansson L, Wells M. Is personalised prehabilitation feasible to implement for patients undergoing oncological treatment for lung cancer at a London teaching hospital? Protocol of a feasibility trial. BMJ Open. 2023 Jul 17;13(7):e072367. doi: 10.1136/bmjopen-2023-072367.
- Individual participant dataSharing planned: No. All participants will be given a unique study number that will be used from the start of the study. Files (e.g. paper consent forms and questionnaires) will be stored in research offices and secured by either lock and key or key code and accessible by only departmental staff or the Trust's security department. Personal data (e.g. patient demographics and results of assessments) will be retained and stored on a networked and password protected NHS computer. Patient data will not be shared with parties outside of the patient's direct clinical care team or local research team. Stored data will be pseudonymised at the time of collection/storage. Data will be collected according to the data protection act 2018 and in line with general data Protection regulation GDPR). Results will be shared in a scientific journal and presented at relevant conferences. Patients will not be identifiable.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Wade-Mcbane principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of level of readiness and need for personalised prehabilitation, Formation of a personalised prehabilitation plan and Daily diary in people with Lung Cancer, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Wade-Mcbane (0203 311 7135, k.wade-mcbane@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasible eligibility, recruitment and refusal rates (time frame: Immediately after week six of oncological treatment). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.