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

Lung Neoplasm Malignant Clinical Trial

— CanBenefitII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05404022
• Other study ID #: RS166
• Status: Completed
• Phase: N/A
• Start date: June 20, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: June 2022
• Source: University of Hull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasm Malignant
• Lung Neoplasms
• Mesothelioma
• Mesothelioma; Lung
• Neoplasms

Intervention

Other:
• Tailored nutrition and physical activity programme
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

Locations

Country	Name	City	State
United Kingdom	Hull University Teaching Hospitals NHS Trust	Hull	Yorkshire
United Kingdom	York and Scarborough Teaching Hospitals NHS Trust	York	Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Hull

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Forbes CC, Swan F, Greenley SL, Lind M, Johnson MJ. Physical activity and nutrition interventions for older adults with cancer: a systematic review. J Cancer Surviv. 2020 Oct;14(5):689-711. doi: 10.1007/s11764-020-00883-x. Epub 2020 Apr 24. — View Citation

Swan F, Chen H, Forbes CC, Johnson MJ, Lind M. CANcer BEhavioural nutrition and exercise feasibility trial (CanBenefit); phase I qualitative interview findings. J Geriatr Oncol. 2021 May;12(4):641-648. doi: 10.1016/j.jgo.2020.09.026. Epub 2020 Oct 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Secondary outcome data completion rate	Assessed by the total number of missing data from the total list of secondary outcomes	24 weeks
Primary	Rate of Intervention Completion	The percentage of exercises prescribed to the participants compared to the number of those completed.	12 weeks
Primary	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
Primary	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	Free-living daily activity	Accelerometer; the activpal4 micro units (activpal4; https://www.palt.com/pals/)	Baseline, 24 weeks
Secondary	Australian Karnofsky Performance Scale (AKPS)	Single score from 10 to 100 (a higher score indicates better performance status).	baseline, 12 and 24 weeks
Secondary	Rockwood Frailty Index, a 7-point Clinical Frailty Scale	1 = very fit, and 7= severely frail.	baseline, 12 and 24 weeks
Secondary	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
Secondary	Grip strength	Maximum force/tension (kg) in the forearm muscles using a handheld dynamometer.	baseline, 12 and 24 weeks
Secondary	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
Secondary	Weight (kg)	Tanita body composition monitor and weight scale	baseline, 12 and 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Days alive and out of hospital	Hospital admission (number of days) since starting the programme	baseline, and after 6, 12, and 24 weeks
Secondary	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
Secondary	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
Secondary	Treatment toxicity	Cancer treatment-related toxicity (CTCAE v 5)	baseline, and after 6, 12, and 24 weeks
Secondary	Height	measured in cm with a Seneca Stadiometer	baseline, 12 and 24 weeks