Ignite Creation Date:
2024-05-06 @ 5:43 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05404022
Status:
COMPLETED
Last Update Posted:
2023-09-13
First Post:
2022-05-12
Brief Title:
Feasibility Trial of a Personalised Nutrition and Activity Programme for People With Lung Cancer Over 65 Years
Sponsor:
University of Hull
Organization:
University of Hull
Study Overview
Official Title:
Cancer Behavioural Nutrition and Exercise Feasibility Trial - Phase II Randomised Controlled Trial Among Older Adults With Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CanBenefitII
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
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 cancerPA 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 mouthoral 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 teams 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 functionnutrition 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 aimobjective
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 aimsobjectives
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 participantclinician acceptability and experience
candidate primary outcomes for subsequent trial
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 cancerPA 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 mouthoral 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 teams 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 functionnutrition 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 aimobjective
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 aimsobjectives
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 participantclinician acceptability and experience
candidate primary outcomes for subsequent trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None