Personalised Diet, Exercise and Emotional Support for Lung Cancer Patients Having Chemotherapy, Radiotherapy or Immunotherapy Treatment
A Personalised Prehabilitation Model for Patients Undergoing Chemotherapy, Radiotherapy and/or Immunotherapy Treatment for Lung Cancer: A Feasibility Pilot Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Oct 2022
Shorter than P25 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedStudy Start
First participant enrolled
October 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedMay 1, 2023
April 1, 2023
8 months
March 15, 2022
April 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (22)
Feasible eligibility, recruitment and refusal rates
Use of descriptive statistics - number approached, eligible, recruited, refused
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Baseline; pre-treatment, during treatment and immediately after treatment
Quality of life assessed using the EuroQOL Group EQ-5D-5L questionnaire
Baseline; pre-treatment, during treatment and immediately after treatment
Patient experience
Immediately after week six of oncological treatment
Functional capacity
Baseline; pre-treatment, during treatment and immediately after treatment
Handgrip strength
Baseline; pre-treatment, during treatment and immediately after treatment
Study Arms (1)
Personalised prehabilitation
EXPERIMENTALA personalised plan of diet, exercise and emotional support for patients having chemotherapy, radiotherapy and/or immunotherapy treatment for lung cancer.
Interventions
Patients 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- On a surgical pathway
- Have had previous lung cancer surgery
- Unable to understand verbal or written English
- Unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College Healthcare NHS Trust
London, W6 8RF, United Kingdom
Related Publications (1)
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.
PMID: 37460263DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Wade-Mcbane
Imperial College Healthcare NHS Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
April 8, 2022
Study Start
October 28, 2022
Primary Completion
June 30, 2023
Study Completion
September 1, 2023
Last Updated
May 1, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
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.