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

Study Overview
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Brief Summary
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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
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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 QoL* and QoL adjusted days alive out of hospital* treatment dose intensity* episodes of infection fatigue functional status To assess participant/clinician acceptability and experience *candidate primary outcomes for subsequent trial

Official Title
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Cancer Behavioural Nutrition and Exercise Feasibility Trial - Phase II Randomised Controlled Trial Among Older Adults With Lung Cancer

Conditions
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Lung Neoplasm Malignant, Mesothelioma; Lung

Intervention / Treatment
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* Other: Tailored nutrition and physical activity programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥65 years, diagnosed with stage III or IV lung cancer or mesothelioma, starting a new line of systemic anti-cancer treatment, willing and able to complete study measures and be randomised able to provide informed written or verbal witnessed consent Exclusion Criteria: Patients receiving radical chemoradiation therapy (potentially curative and require parental feeding) Have had more than one dose of new treatment. Unstable acute condition (e.g., acute infection, severe uncontrolled symptoms) or Underlying chronic condition (e.g., severe arthritis or dementia) that would impact study compliance. Unable to provide written or verbal consent. Insufficient English for consent and study procedures and appropriate interpretation unavailable

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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). | Other: Tailored nutrition and physical activity programme<br>* Physical activity prescriptions will follow recent guidance for people with cancer and the FITT principles: Frequency (weekly sessions), Intensity (how hard), Time (session duration), and Type. Programme content, duration, and intensity will be tailored for comorbidities and other limitations. Nutrition prescription may include any or all of the following: Information on side-effects that may affect eating and their mitigation Feedback on physical measures (weight loss) in relation to nutrition and treatment outcomes Feedback on assessment of food intake and how to improve a Macmillan booklet: advice on eating and maintaining weight throughout cancer treatments. a recipe book Making the most of every bite tailored oral nutritional support, including use of high calorie/protein nutrition supplementation, or other macro and micronutrient supplementation as required<br>|
| No Intervention: Usual care arm<br>The usual cancer care will include usual patient management and care prior, during and after cancer treatment - medication, symptom control, cancer advice and support from routine medical and nursing input with access to Allied Health Professionals (AHPs) such as physiotherapists and dietitians as clinically indicated. As part of this, it is common for older adults with cancer to be prescribed high protein supplementation. Control participants will receive a general information leaflet regarding activity and nutrition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | 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. | 24 weeks | 
| Retention Rate | 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. | 24 weeks | 
| Secondary outcome data completion rate | Assessed by the total number of missing data from the total list of secondary outcomes | 24 weeks | 
| Rate of Intervention Completion | The percentage of exercises prescribed to the participants compared to the number of those completed. | 12 weeks | 
| Incidence of adverse effects and injuries related to the intervention | Assessed by the number and rate of participant recorded adverse effects and injuries related to the intervention | Week 1 to week 12 | 
| Incidence of adverse events not related to the intervention | 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 | Week 1 to week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free-living daily activity | Accelerometer; the activpal4 micro units (activpal4; https://www.palt.com/pals/) | Baseline, 24 weeks | 
| Australian Karnofsky Performance Scale (AKPS) | Single score from 10 to 100 (a higher score indicates better performance status). | baseline, 12 and 24 weeks | 
| Rockwood Frailty Index, a 7-point Clinical Frailty Scale | 1 = very fit, and 7= severely frail. | baseline, 12 and 24 weeks | 
| Short Physical Performance Battery (SPBB) | Combines standing balance, 4 metre gait speed, and timed sit-to-stands to assess lower extremity function in older people | baseline, 12 and 24 weeks | 
| Grip strength | Maximum force/tension (kg) in the forearm muscles using a handheld dynamometer. | baseline, 12 and 24 weeks | 
| Bioelectrical impedance | Tanita body composition monitor and weight scale, a simple, non-invasive technique for measuring body composition in people with cancer | baseline, 12 and 24 weeks | 
| Weight (kg) | Tanita body composition monitor and weight scale | baseline, 12 and 24 weeks | 
| Patient-Generated Subjective Global Assessment (PG-SGA) | 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). | baseline and after 6, 12, and 24 weeks | 
| Community Healthy Activities Model Program for Seniors (CHAMPS) | Self-report total physical activity questionnaire designed to estimate weekly frequency of participation and energy expenditure in physical activities. | baseline and after 6, 12, and 24 weeks | 
| Integrated Patient Outcome Scale (IPOS) | 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) | baseline and after 6, 12, and 24 weeks | 
| Client Service Receipt Inventory | Validated questionnaire designed to collect information on service utilisation, income, accommodation and other cost-related variables | baseline and after 6, 12, and 24 weeks | 
| EuroQol-5 Dimensions-5 Levels | 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). | baseline and after 6, 12, and 24 weeks | 
| EuroQol-Visual Analogue Scale | 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. | baseline and after 6, 12, and 24 weeks | 
| Days alive and out of hospital | Hospital admission (number of days) since starting the programme | baseline, and after 6, 12, and 24 weeks | 
| Treatment completion rate | Dose of cancer therapy received (percentage of dose received/dose prescribed) Treatment delay (days delayed) | baseline, and after 6, 12, and 24 weeks | 
| Infection rate | Assessed by the number of episodes requiring antibiotics (oral/IV) Number of episodes requiring hospital admission (number of days) | baseline, and after 6, 12, and 24 weeks | 
| Treatment toxicity | Cancer treatment-related toxicity (CTCAE v 5) | baseline, and after 6, 12, and 24 weeks | 
| Height | measured in cm with a Seneca Stadiometer | baseline, 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Activity, Nutrition, Feasibility RCT, Lung cancer, Older adults