A Personalised Prehabilitation Model for Patients Undergoing Chemotherapy, Radiotherapy and/or Immunotherapy Treatment for Lung Cancer: A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of participants who are not suitable for the personalised prehabilitation programme and the reasons why
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •On a surgical pathway
- •Have had previous lung cancer surgery
- •Unable to understand verbal or written English
- •Unable to give informed consent
结局指标
主要结局
Number of participants who are not suitable for the personalised prehabilitation programme and the reasons why
时间窗: 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
时间窗: 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
时间窗: Immediately after week six of oncological treatment
Adherence to goals set measured through participant discussion at the weekly telephone consultations
Evaluation of participant acceptability of the modified Godin leisure time exercise questionnaire used for the personalised prehabilitation programme
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
Evaluation of participant acceptability of the patient generated index used for the personalised prehabilitation programme
时间窗: 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
时间窗: 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
时间窗: 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
The extent to which the prehabilitation programme has had an impact on nutrition
时间窗: 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
Feasible eligibility, recruitment and refusal rates
时间窗: Immediately after week six of oncological treatment
Use of descriptive statistics - number approached, eligible, recruited, refused
Evaluation of participant acceptability of the patient generated subjective global assessment questionnaire used for the personalised prehabilitation programme
时间窗: 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
The extent to which the prehabilitation programme has had an impact on physical activity
时间窗: 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
How many participants do not participate in the personalised prehabilitation programme and explore the reasons why
时间窗: 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
Barriers and facilitators to adherence and intervention fidelity
时间窗: 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
时间窗: 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
时间窗: 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 effectiveness of the intervention/s
时间窗: 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
Number of participants who require universal, targeted and specialist intervention
时间窗: Immediately after week six of oncological treatment
Use of questionnaires to assess level of need and readiness and descriptive statistics
Evaluation of participant acceptability of the cancer behaviour inventory questionnaire used for the personalised prehabilitation programme
时间窗: 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
The extent to which the prehabilitation programme has had an impact on psychological wellbeing
时间窗: 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
次要结局
- Quality of life assessed using the EuroQOL Group EQ-5D-5L questionnaire(Baseline; pre-treatment, during treatment and immediately after treatment)
- Functional capacity(Baseline; pre-treatment, during treatment and immediately after treatment)
- Handgrip strength(Baseline; pre-treatment, during treatment and immediately after treatment)
- Patient experience(Immediately after week six of oncological treatment)
- 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)