Clinical trial NCT05318807: Personalised Diet, Exercise and Emotional Support for Lung Cancer Patients Having Chemotherapy, Radiotherapy or Immunotherapy Treatment
Official title: A Personalised Prehabilitation Model for Patients Undergoing Chemotherapy, Radiotherapy and/or Immunotherapy Treatment for Lung Cancer: A Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: prehabilitation
radiotherapy
chemotherapy
feasibility
immunotherapy
nutrition
physical activity
psychological wellbeing
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility pilot study
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* On a surgical pathway
* Have had previous lung cancer surgery
* Unable to understand verbal or written English
* Unable to give informed consent

Primary outcomes:
measure: Feasible eligibility, recruitment and refusal rates
timeFrame: Immediately after week six of oncological treatment
measure: How many participants do not participate in the personalised prehabilitation programme and explore the reasons why
timeFrame: Immediately after week six of oncological treatment
measure: Number of participants who are not suitable for the personalised prehabilitation programme and the reasons why
timeFrame: Immediately after week six of oncological treatment
measure: Attrition rate throughout the personalised prehabilitation programme
timeFrame: Immediately after week six of oncological treatment
measure: Number of participants who adhere to the goals set for the personalised prehabilitation interventions
timeFrame: Immediately after week six of oncological treatment
measure: Barriers and facilitators to adherence and intervention fidelity
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of participant acceptability of the emotion thermometer questionnaire used for the personalised prehabilitation programme
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of participant acceptability of the modified Godin leisure time exercise questionnaire used for the personalised prehabilitation programme
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of participant acceptability of the patient generated subjective global assessment questionnaire used for the personalised prehabilitation programme
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of participant acceptability of the patient activation measure questionnaire used for the personalised prehabilitation programme
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of participant acceptability of the cancer behaviour inventory questionnaire used for the personalised prehabilitation programme
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of participant acceptability of the patient generated index used for the personalised prehabilitation programme
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of participant acceptability of measuring body weight in kilograms for the personalised prehabilitation progamme
timeFrame: Immediately after week six of oncological treatment
measure: 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
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of participant acceptability of measuring grip strength in kilograms using a handgrip dynamometer as part of the personalised prehabilitation programme
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of contextual or implementation factors which may influence acceptability of the intervention/s
timeFrame: Immediately after week six of oncological treatment
measure: Evaluation of contextual or implementation factors which may influence effectiveness of the intervention/s
timeFrame: Immediately after week six of oncological treatment
measure: The 'prehabilitation window' (length of time between diagnosis and the start of treatment)
timeFrame: Immediately after week six of oncological treatment
measure: The extent to which the prehabilitation programme has had an impact on psychological wellbeing
timeFrame: Immediately after week six of oncological treatment
measure: The extent to which the prehabilitation programme has had an impact on nutrition
timeFrame: Immediately after week six of oncological treatment
measure: The extent to which the prehabilitation programme has had an impact on physical activity
timeFrame: Immediately after week six of oncological treatment
measure: Number of participants who require universal, targeted and specialist intervention
timeFrame: Immediately after week six of oncological treatment
Secondary outcomes:
measure: Quality of life assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQC30 questionnaire
timeFrame: Baseline; pre-treatment, during treatment and immediately after treatment
measure: Quality of life assessed using the EuroQOL Group EQ-5D-5L questionnaire
timeFrame: Baseline; pre-treatment, during treatment and immediately after treatment
measure: Patient experience
timeFrame: Immediately after week six of oncological treatment
measure: Functional capacity
timeFrame: Baseline; pre-treatment, during treatment and immediately after treatment
measure: Handgrip strength
timeFrame: Baseline; pre-treatment, during treatment and immediately after treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Kelly Wade-Mcbane
role: PRINCIPAL_INVESTIGATOR
References: