Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years

Not Applicable

Completed

• Conditions: Lung Neoplasm Malignant; Mesothelioma; Lung
• Interventions: Other: Tailored nutrition and physical activity programme

• Registration Number: NCT05404022
• Lead Sponsor: University of Hull

Brief Summary

People with cancer affecting the lungs tend to be older and frailer compared to people with other cancers. As a result, they may have poorer quality of life and are less able to tolerate treatments for their cancer, such as chemotherapy. Research to date show that nutrition and physical activity support helps people with cancer, but not many older people are included in these studies.

The investigators want to develop and test a nutrition and activity programme for older people with lung cancer that can be tailored to each patient to help them have the best possible quality of life from the moment they start a new line of cancer treatment.

The research team has conducted the development work to find which nutrition and activity programmes are best for this patient group and how best to deliver the programme by looking at prior studies and talking to patients and carers as well as health care providers.

The next step is to test the developed programme in a small pilot study, to i) see if it is possible and acceptable (to patients, families, and staff) to deliver and ii) see if it helps patients have and cope with anti-cancer treatments and improve patient quality of life.

Detailed Description

BACKGROUND

Lung cancer is the third most commonly diagnosed cancer in the UK and most common in Yorkshire. It is also the most common cause of cancer death in UK. People with lung cancer are often older with co-morbidities and frailty resulting in a poor prognosis - especially if they are unfit for treatment. Approximately half of new cancer cases in UK are people aged 65 and over. Frailty, with sarcopenia (age-related decline in skeletal muscle), cachexia (disease-related body wasting) and nutritional deficiencies, may limit chemotherapy options, reduce treatment effectiveness, result in dose reductions and poor treatment completion rates.

Physical activity (PA) interventions benefit people living with or beyond cancer by improving physical function and quality of life (QoL) during and after cancer treatment. Reduced physical function is associated with higher mortality in older adults with cancer.PA improves treatment completion, treatment recovery, survival rates and reduces healthcare use. Emerging work indicates that activity improves immune function in older adults with cancer; important as better immune function has been linked to improved treatment outcomes. A recent meta-analysis shows reduced risk of cancer-specific and all-cause mortality for those more active among people with lung cancer.

Weight loss and poor nutrition may prevent patients from completing cancer treatments and increase the risk and severity of treatment toxicity. In those receiving chemotherapy, better nutritional status is associated with improved survival and, in lung cancer patients undergoing chemotherapy, better QoL. Cancer treatments can cause many side-effects that impact eating, including; fatigue, nausea, vomiting, dry mouth/oral candidiasis, disordered taste, ill-fitting dentures, diarrhoea, constipation, oesophagitis, early satiety and poor appetite; all difficult for patients to self-manage. Nutritional interventions, including dietary counselling and nutrition advice, improve patient wellbeing and rate of treatment completion. Despite the urgent need for improvements in survival outcomes for older people with lung cancer, a significant evidence gap remains regarding nutrition.

This team's systematic review highlighted the lack of PA and nutrition programme research for older adults living with and beyond cancer. Studies including older adults often focus on prostate cancer, generally a group with a better prognosis. Therefore, many older adults with other cancers, such as lung cancer (only one study in our review), are not represented. Qualitative interviews with patients, carers, and clinicians in Hull (with experience of lung cancer) confirmed poor access to, but support for and interest in, wellbeing interventions but only if tailored to their needs - including management of activity-related breathlessness.

A tailored wellbeing intervention, designed to improve or maintain physical function via lifestyle behaviours, may decrease older adults with lung cancer needing dose reductions. Dose intensity is significantly associated with mortality among people receiving treatment for lung cancer. By maintaining physical function/nutrition, people can tolerate more treatment with subsequent better overall survival. This could be very significant among people diagnosed with lung cancer, a cancer with generally poor prognosis.

Therefore, the aim of this study is to investigate the feasibility and acceptability of conducting a future definitive trial of a tailored wellbeing (nutrition and activity) programme for older adults with lung cancers who are starting a new line of systemic anticancer therapy.

AIMS AND OBJECTIVES

Primary aim/objective

To determine the feasibility and acceptability of a tailored wellbeing (nutrition and activity) programme for older adults with lung cancer beginning a new line of systemic anti-cancer therapy in terms of recruitment, intervention delivery, appropriateness of candidate primary outcomes, estimated sample size for a future phase III trial.

Secondary aims/objectives

To assess data quality

1. QoL\* and QoL adjusted days alive out of hospital\*

2. treatment dose intensity\*

3. episodes of infection

4. fatigue

5. functional status

To assess participant/clinician acceptability and experience

\*candidate primary outcomes for subsequent trial

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-30
• Status Verified: 2022-06
• Study First Posted: 2022-06-03
• Study Start: 2022-06-20
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. age ≥65 years,
2. diagnosed with stage III or IV lung cancer or mesothelioma,
3. starting a new line of systemic anti-cancer treatment,
4. willing and able to complete study measures and be randomised
5. able to provide informed written or verbal witnessed consent

Exclusion Criteria

1. Patients receiving radical chemoradiation therapy (potentially curative and require parental feeding)
2. Have had more than one dose of new treatment.
3. Unstable acute condition (e.g., acute infection, severe uncontrolled symptoms) or
4. Underlying chronic condition (e.g., severe arthritis or dementia) that would impact study compliance.
5. Unable to provide written or verbal consent.
6. Insufficient English for consent and study procedures and appropriate interpretation unavailable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Tailored nutrition and physical activity programme	12 weeks home based tailored nutrition and physical activity (PA) programme Participants will have an appointment (face-to-face if possible) with the study physiotherapist and dietitian for delivery of the PA (including breathlessness management) and nutrition intervention components. Participants will receive study equipment at these appointments (or by post) including paper-based tracking diary, resistance bands for strength exercises, a Fitbit activity monitor to track steps and aerobic activity during the study period, nutritional supplements (if prescribed), and printed study materials (if preferred over pdf emails; e.g. cooking tips, recipes). A video/telephone follow-up call (10-15 minutes) will be conducted by the research team with the participant at weeks 2,3,4,5 and 6 and then at weeks 8,10 and 12 to review and adjust their programme (with input from the physiotherapist and dietitian if required).

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	24 weeks	The Recruitment Rate will be assessed by the number of eligible patients approached vs the number of eligible patients consent for the study, providing a number of non-participations. This will be gathered as an aspect of feasibility.
Retention Rate	24 weeks	Retention rate will be examined via the number of those who consent to the study compared to the number of those who complete the study.
Secondary outcome data completion rate	24 weeks	Assessed by the total number of missing data from the total list of secondary outcomes
Incidence of adverse effects and injuries related to the intervention	Week 1 to week 12	Assessed by the number and rate of participant recorded adverse effects and injuries related to the intervention
Incidence of adverse events not related to the intervention	Week 1 to week 52	The number of adverse events exhibited by the participants will be recorded with an associated grade (where relevant). A example list of adverse events are given below: * Constipation; * Nausea; * Vomiting; * Diarrhoea; * Skin Rash
Rate of Intervention Completion	12 weeks	The percentage of exercises prescribed to the participants compared to the number of those completed.

Secondary Outcome Measures

Name	Time	Method
Free-living daily activity	Baseline, 24 weeks	Accelerometer; the activpal4 micro units (activpal4; https://www.palt.com/pals/)
Australian Karnofsky Performance Scale (AKPS)	baseline, 12 and 24 weeks	Single score from 10 to 100 (a higher score indicates better performance status).
Short Physical Performance Battery (SPBB)	baseline, 12 and 24 weeks	Combines standing balance, 4 metre gait speed, and timed sit-to-stands to assess lower extremity function in older people
Bioelectrical impedance	baseline, 12 and 24 weeks	Tanita body composition monitor and weight scale, a simple, non-invasive technique for measuring body composition in people with cancer
Community Healthy Activities Model Program for Seniors (CHAMPS)	baseline and after 6, 12, and 24 weeks	Self-report total physical activity questionnaire designed to estimate weekly frequency of participation and energy expenditure in physical activities.
Days alive and out of hospital	baseline, and after 6, 12, and 24 weeks	Hospital admission (number of days) since starting the programme
Treatment completion rate	baseline, and after 6, 12, and 24 weeks	Dose of cancer therapy received (percentage of dose received/dose prescribed) Treatment delay (days delayed)
Height	baseline, 12 and 24 weeks	measured in cm with a Seneca Stadiometer
Rockwood Frailty Index, a 7-point Clinical Frailty Scale	baseline, 12 and 24 weeks	1 = very fit, and 7= severely frail.
Grip strength	baseline, 12 and 24 weeks	Maximum force/tension (kg) in the forearm muscles using a handheld dynamometer.
Weight (kg)	baseline, 12 and 24 weeks	Tanita body composition monitor and weight scale
Patient-Generated Subjective Global Assessment (PG-SGA)	baseline and after 6, 12, and 24 weeks	Assessment of nutritional status for people with cancer (scores from 0 - ≥9; 2-3 indicating need for basic nutrition intervention, 4-8 requiring dietetic intervention, and scores ≥9 indicating critical need for symptom management and nutritional intervention).
Integrated Patient Outcome Scale (IPOS)	baseline and after 6, 12, and 24 weeks	measure of symptom burden with 20 items: one free-text question about main problems and concerns, 17 items on physical, psychological, spiritual problems, communication needs including with family, and practical support, scored on a 5-point Likert-type scale from 0 (best) to 4 (worst)
Client Service Receipt Inventory	baseline and after 6, 12, and 24 weeks	Validated questionnaire designed to collect information on service utilisation, income, accommodation and other cost-related variables
Infection rate	baseline, and after 6, 12, and 24 weeks	Assessed by the number of episodes requiring antibiotics (oral/IV) Number of episodes requiring hospital admission (number of days)
EuroQol-5 Dimensions-5 Levels	baseline and after 6, 12, and 24 weeks	The EQ-5D-5L is a generic health-related quality-of-life instrument with a descriptive system that comprises five dimensions (1) mobility, 2) self-care, 3) usual activities, 4) pain/discomfort, and 5) anxiety/depression), each of which has five levels of severity (given in statement form). Participants select a statement under each of the five dimensions which best suits their current state. In addition, the respiratory bolt on dimension for the EQ-5D-5L. For each dimension, lower scores indicate fewer problems in that domain (e.g. a score of 1 in mobility means no issues with mobility).
EuroQol-Visual Analogue Scale	baseline and after 6, 12, and 24 weeks	The EQ-VAS is a self-report measure of overall health using a vertical visual analogue scale, ranging from 0 labelled as "worst possible" to 100 labelled as "best possible" health. Participants are then asked to write this number in a dedicated box.
Treatment toxicity	baseline, and after 6, 12, and 24 weeks	Cancer treatment-related toxicity (CTCAE v 5)

Trial Locations

Locations (2)

York and Scarborough Teaching Hospitals NHS Trust; 🇬🇧 York, Yorkshire, United Kingdom

Hull University Teaching Hospitals NHS Trust; 🇬🇧 Hull, Yorkshire, United Kingdom