Personalised Diet, Exercise and Emotional Support for Lung Cancer Patients Having Chemotherapy, Radiotherapy or Immunotherapy Treatment

NCT05318807 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-01

No results posted yet for this study

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.

Conditions

Interventions

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: 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

Formation of a personalised prehabilitation plan

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.

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.

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Kelly Wade-Mcbane · Imperial College Healthcare NHS Trust

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2023-06-30
Completion
2023-09-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318807 on ClinicalTrials.gov