Lung Neoplasm MalignantCanBenefitIINCT05404022
Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years
A study testing Tailored nutrition and physical activity programme in people with Lung Neoplasm Malignant and Mesothelioma; Lung, run by University of Hull at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Lung Neoplasm Malignant, Mesothelioma; Lung
- What is being tested?
- Tailored nutrition and physical activity programme
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Jun 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Hull University Teaching Hospitals NHS Trust
Hull, Yorkshire, HU16 5JQ
York and Scarborough Teaching Hospitals NHS Trust
York, Yorkshire, YO31 8HE
About this study
Official title: Cancer Behavioural Nutrition and Exercise Feasibility Trial - Phase II Randomised Controlled Trial Among Older Adults With Lung Cancer
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.
Read more
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.
Read the 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
- 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
- Conditions
- Lung Neoplasm Malignant, Mesothelioma; Lung
- Being tested
- Tailored nutrition and physical activity programme
- Keywords
- Physical Activity, Nutrition, Feasibility RCT, Lung cancer, Older adults
- Medical subject headings
- Lung Neoplasms, Mesothelioma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored nutrition and physical activity programmeOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 weeks
Secondary outcome data completion rate
Assessed by the total number of missing data from the total list of secondary outcomes
Measured: 24 weeks
Rate of Intervention Completion
The percentage of exercises prescribed to the participants compared to the number of those completed.
Measured: 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
Measured: 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
Measured: Week 1 to week 52
Secondary outcomes (18)
Free-living daily activity
Accelerometer; the activpal4 micro units (activpal4; https://www.palt.com/pals/)
Measured: Baseline, 24 weeks
Australian Karnofsky Performance Scale (AKPS)
Single score from 10 to 100 (a higher score indicates better performance status).
Measured: baseline, 12 and 24 weeks
Rockwood Frailty Index, a 7-point Clinical Frailty Scale
1 = very fit, and 7= severely frail.
Measured: 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
Measured: baseline, 12 and 24 weeks
Grip strength
Maximum force/tension (kg) in the forearm muscles using a handheld dynamometer.
Measured: 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
Measured: baseline, 12 and 24 weeks
Weight (kg)
Tanita body composition monitor and weight scale
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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.
Measured: baseline and after 6, 12, and 24 weeks
Days alive and out of hospital
Hospital admission (number of days) since starting the programme
Measured: 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)
Measured: 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)
Measured: baseline, and after 6, 12, and 24 weeks
Treatment toxicity
Cancer treatment-related toxicity (CTCAE v 5)
Measured: baseline, and after 6, 12, and 24 weeks
Height
measured in cm with a Seneca Stadiometer
Measured: baseline, 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start20 Jun 2022
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Forbes, PhD, Principal investigator, Hull York Medical School, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404022
- Sponsor's protocol ID
- RS166
- Acronym
- CanBenefitII
- Status last verified
- Jun 2022
- First submitted
- 12 May 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33059998Forbes 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.
PubMed 32328828
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Behavioural Nutrition and Exercise Feasibility Trial - Phase II Randomised Controlled Trial Among Older Adults With Lung Cancer
- ClinicalTrials.gov ID
- NCT05404022
- Acronym / sponsor ID
- CanBenefitII / RS166
- Conditions
- Lung Neoplasm Malignant, Mesothelioma; Lung
- Keywords
- Physical Activity, Nutrition, Feasibility RCT, Lung cancer, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Tailored nutrition and physical activity programme12 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). |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored nutrition and physical activity programmePhysical 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 | Other | Intervention arm |
Primary outcome
Recruitment Rate
Time frame: 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
Time frame: 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
Time frame: 24 weeks
Assessed by the total number of missing data from the total list of secondary outcomes
Rate of Intervention Completion
Time frame: 12 weeks
The percentage of exercises prescribed to the participants compared to the number of those completed.
Incidence of adverse effects and injuries related to the intervention
Time frame: 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
Time frame: 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
18 secondary outcomes
Free-living daily activity
Time frame: Baseline, 24 weeks
Australian Karnofsky Performance Scale (AKPS)
Time frame: baseline, 12 and 24 weeks
Rockwood Frailty Index, a 7-point Clinical Frailty Scale
Time frame: baseline, 12 and 24 weeks
Short Physical Performance Battery (SPBB)
Time frame: baseline, 12 and 24 weeks
Grip strength
Time frame: baseline, 12 and 24 weeks
Bioelectrical impedance
Time frame: baseline, 12 and 24 weeks
Weight (kg)
Time frame: baseline, 12 and 24 weeks
Patient-Generated Subjective Global Assessment (PG-SGA)
Time frame: baseline and after 6, 12, and 24 weeks
Community Healthy Activities Model Program for Seniors (CHAMPS)
Time frame: baseline and after 6, 12, and 24 weeks
Integrated Patient Outcome Scale (IPOS)
Time frame: baseline and after 6, 12, and 24 weeks
Client Service Receipt Inventory
Time frame: baseline and after 6, 12, and 24 weeks
EuroQol-5 Dimensions-5 Levels
Time frame: baseline and after 6, 12, and 24 weeks
EuroQol-Visual Analogue Scale
Time frame: baseline and after 6, 12, and 24 weeks
Days alive and out of hospital
Time frame: baseline, and after 6, 12, and 24 weeks
Treatment completion rate
Time frame: baseline, and after 6, 12, and 24 weeks
Infection rate
Time frame: baseline, and after 6, 12, and 24 weeks
Treatment toxicity
Time frame: baseline, and after 6, 12, and 24 weeks
Height
Time frame: baseline, 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Results publication: PubMed 33059998Swan 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.
- Results publication: PubMed 32328828Forbes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Forbes, PhD principal investigator
Hull York Medical School, University of Hull
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored nutrition and physical activity programme in people with Lung Neoplasm Malignant and Mesothelioma; Lung, run by University of Hull at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05404022, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.