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

NCT ID: NCT05404022

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-20
• Study Completion Date: 2023-09-01

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

Conditions

Lung Neoplasm Malignant; Mesothelioma; Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention arm

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).

Group Type: EXPERIMENTAL

Tailored nutrition and physical activity programme

Intervention Type: OTHER

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:

1. Information on side-effects that may affect eating and their mitigation

2. Feedback on physical measures (weight loss) in relation to nutrition and treatment outcomes

3. Feedback on assessment of food intake and how to improve

4. a Macmillan booklet: advice on eating and maintaining weight throughout cancer treatments.

5. a recipe book "Making the most of every bite"

6. tailored oral nutritional support, including use of high calorie/protein nutrition supplementation, or other macro and micronutrient supplementation as required

Usual care arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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:

1. Information on side-effects that may affect eating and their mitigation

2. Feedback on physical measures (weight loss) in relation to nutrition and treatment outcomes

3. Feedback on assessment of food intake and how to improve

4. a Macmillan booklet: advice on eating and maintaining weight throughout cancer treatments.

5. a recipe book "Making the most of every bite"

6. tailored oral nutritional support, including use of high calorie/protein nutrition supplementation, or other macro and micronutrient supplementation as required

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hull

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia Forbes, PhD

Role: PRINCIPAL_INVESTIGATOR

Hull York Medical School, University of Hull

Locations

Hull University Teaching Hospitals NHS Trust

Hull, Yorkshire, United Kingdom

York and Scarborough Teaching Hospitals NHS Trust

York, Yorkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 33059998 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32328828 (View on PubMed)

Other Identifiers

RS166

Identifier Type: -

Identifier Source: org_study_id