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

NCT05404022 | Completed

• 1 other identifier: RS166
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Neoplasm Malignant; Mesothelioma; Lung

Keywords

Physical Activity; Nutrition; Feasibility RCT; Lung cancer; Older adults

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (18)

• Free-living daily activity

  Baseline, 24 weeks

• Australian Karnofsky Performance Scale (AKPS)

  baseline, 12 and 24 weeks

• Rockwood Frailty Index, a 7-point Clinical Frailty Scale

  baseline, 12 and 24 weeks

• Short Physical Performance Battery (SPBB)

  baseline, 12 and 24 weeks

• Grip strength

  baseline, 12 and 24 weeks

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Usual care arm

NO INTERVENTION

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.

Interventions

Tailored nutrition and physical activity programme 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

Intervention arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hull: lead

Study Sites (2)

Hull University Teaching Hospitals NHS Trust

Hull, Yorkshire, HU16 5JQ, United Kingdom

Location

York and Scarborough Teaching Hospitals NHS Trust

York, Yorkshire, YO31 8HE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33059998 RESULT

• 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.

  PMID: 32328828 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Mesothelioma; Motor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Behavior

Study Officials

• Cynthia Forbes, PhD

  Hull York Medical School, University of Hull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 3, 2022
• Study Start: June 20, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 13, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)