Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04575831
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2020-09-11
Brief Title:
Exercise Nutrition and Palliative Care in Advanced Lung Cancer ENPAL
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
The Feasibility of an Exercise and Nutrition Supportive Care Palliative Intervention for Advanced Non-small-cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2020-09
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:
ENPAL
Brief Summary:
Background Evidence supports exercise and nutrition as beneficial for enhancing QOL in earlier stages of lung cancer however there is minimal research of either intervention - and none with combined interventions - in advanced lung cancer patients In addition to a multimodal intervention approach that includes nutrition and exercise consideration of advanced cancer care symptom management is crucial for optimizing the potential benefits of either intervention
Objectives Primary outcome measure of this study is feasibility including recruitment who participate from those eligible attendance weekly group class assessment completion safety adverse event reporting attrition rates and qualitative themes generated from one-on-one participant interviews The secondary outcome to be measured is the impact of the intervention on PROs including QOL fatigue and symptom burden as well as self-reported physical activity levels and physical function assessed in-person
Methods The proposed exercise intervention will include a centre-based group exercise program plus home-based exercises and behaviour change support for advanced non-small cell lung cancer NSCLC patients classified as stage III or IV with self-reported symptom burden Eligible participants must be cleared by the health care professionals HCP to engage in mild to moderate levels of physical activity PA Using a prospective mixed-methods design supported by the Medical Research Council guidance for the evaluation of complex interventions the quantitative component of this pilot study will measure feasibility and exploratory outcome measures with an embedded qualitative component to examine participant perspectives about study tolerabilityfeasibility of the intervention A subset of participants and instructors will be recruited for qualitative interviews using purposive sampling to achieve maximum variation based on factors that may lead to different viewpoints eg age gender lung cancer typestage treatment
Relevance The proposed work will inform the design of a future pragmatic trial for this population The goal is to build a patient-focused model of care that delivers wellness resources for advanced lung cancer care that will ultimately improve the patients health and QOL This approach is novel patient-focused and will build a tailored approach within existing resources to deliver optimal care
Objectives Primary outcome measure of this study is feasibility including recruitment who participate from those eligible attendance weekly group class assessment completion safety adverse event reporting attrition rates and qualitative themes generated from one-on-one participant interviews The secondary outcome to be measured is the impact of the intervention on PROs including QOL fatigue and symptom burden as well as self-reported physical activity levels and physical function assessed in-person
Methods The proposed exercise intervention will include a centre-based group exercise program plus home-based exercises and behaviour change support for advanced non-small cell lung cancer NSCLC patients classified as stage III or IV with self-reported symptom burden Eligible participants must be cleared by the health care professionals HCP to engage in mild to moderate levels of physical activity PA Using a prospective mixed-methods design supported by the Medical Research Council guidance for the evaluation of complex interventions the quantitative component of this pilot study will measure feasibility and exploratory outcome measures with an embedded qualitative component to examine participant perspectives about study tolerabilityfeasibility of the intervention A subset of participants and instructors will be recruited for qualitative interviews using purposive sampling to achieve maximum variation based on factors that may lead to different viewpoints eg age gender lung cancer typestage treatment
Relevance The proposed work will inform the design of a future pragmatic trial for this population The goal is to build a patient-focused model of care that delivers wellness resources for advanced lung cancer care that will ultimately improve the patients health and QOL This approach is novel patient-focused and will build a tailored approach within existing resources to deliver optimal care
Detailed Description:
Lung cancer is the most commonly diagnosed cancer in Canada and is the leading cause of death from cancer1 Despite this long-term survival rates for lung cancer are improving owing largely to recent advances in treatment The progression of symptoms of advanced lung cancer often exacerbate the emotional and psychological distress experienced by patients and families which contributes to sedentary behaviour as well as diminished QOL2 In addition the toxicities of traditional chemotherapies such as the reduction of lean muscle mass345 are not adequately addressed in current research or used in clinical practice The proposed work will thus assess the feasibility and patient impact of an integrated multimodal intervention for advanced stage III and IV non-small-cell lung cancer NSCLC inclusive of tailored exercise programming nutrition counselling and behaviour change support in addition to palliative symptom management
Evidence shows that physical function and physical independence are among the most important determinants of QOL for cancer patients with palliative care needs6 There is strong empirical evidence to demonstrate the positive impact of each individual modality included in the proposed intervention - symptom management nutrition and exercise - on QOL in advanced cancer populations including patients with metastatic NSCLC78 Nutritional status has been shown to be predictive of QOL in patients with cancer including in those diagnosed with inoperable NSCLC9 Exercise is also supported as beneficial for overall QOL in advanced cancer populations with particularly strong effects on physical and mental well-being10 Exercise promotes the retention and utilization of nutrients and anabolism while palliative symptom measures can help improve oral intake by ameliorating symptoms such as nausea mucositis thrush or constipation11 Palliative symptom measures may also help reduce obstacles to exercise such as pain or dyspnea that are commonly experienced by patients with advanced lung cancer Despite the promising evidence few studies have examined the effect of combining a nutrition and exercise intervention within palliative care yet preliminary data suggests synergistic effects Results from a recent randomized control trial suggest that an intervention combining nutrition and exercise components may be feasible in advanced cancer care including stage IV NSCLC care with an attrition rate of only 86 during the 3-month trial period 12 While this is promising there is still limited data on the feasibility of these interventions and there have been no RCTs to date that have combined palliative care with nutrition and exercise interventions Hall CC Cook J Maddocks M et al Combined exercise and nutritional rehabilitation in outpatients with incurable cancer a systematic review Support Care Cancer 2019 272371-2384 1314
Given the growing number of NSCLC patients entering long-term survivorship this work is critical for ensuring that the healthcare system is addressing their unique supportive and palliative care needs Our project is relevant to the present funding opportunity because of its focus on patient reported outcomes PROs We will utilize PROs that are used in AHS Putting Patients First and in the cancer population FACT-G FACT-lung and FACIT-F and will collect patient feedback qualitative interviews on the intervention recruitment and delivery This work will also help connect existing palliative resources at the Tom Baker Cancer Centre Complex Cancer Care team physiatry and nutrition along with ongoing work on the University of Calgarys Alberta Cancer Exercise ACE program15 The preliminary outcome and feasibility data will inform the sample size and characteristics for a future PCT By showing proof of concept in advanced lung cancer a disease with high patient burden we hope results from this work will facilitate further adaptation of the proposed multimodal intervention to support the palliative care needs of other tumour groups
Research Objectives
This pilot study will examine a multimodal intervention including exercise and nutrition in conjunction with palliative symptom management on the QOL of advanced NSCLC patients The impact of symptom burden on the QOL in NSCLC patients is significant and under-recognized Due to improvements in therapies there is an opportunity to address QOL in this population whose members are now on average living longer and potentially more able to engage in rehabilitation interventions This work will address a gap in research and clinical practice by providing initial data that to examine delivery of supportive and palliative cancer care to the advanced NSCLC population and provide a starting point for tailoring interventions in other tumour groups Given the novel nature of this research both in terms of the multimodal intervention as well as the focus on an underserved population the primary objective is to assess the feasibility of the intervention Secondary objectives are to obtain preliminary data on patient-reported outcomes PROs of QOL FACT-G and FACT-lung and patient functioning measures symptom measurement Putting Patients First assessment tool exercise levels and fitness outcomes
Methodology
This pilot study will involve a prospective mixed-methods design The quantitative component includes measures of study feasibility and exploratory outcome measures as described below The embedded qualitative component will use semi-structured one-on-one interviews to explore participant perspectives about intervention tolerabilityfeasibility with a focus on barriers and facilitators to participation perspectives on recruitment the type and combination of intervention modalities exercise type role of instructor and content within the palliative symptom and nutrition intervention delivery locations duration of the intervention and satisfaction with the outcome measures used The rationale for this study design follows the Medical Research Council guidelines for the evaluation of complex interventions1617 which supports the use of qualitative methods nested within a larger trial to understand the active ingredients and contextual factors that result in certain outcomes in a complex intervention study This has been used as a framework for previously published complex intervention trials in palliative care18 19 Research Team Co-Principal Investigators Culos-Reed and Abdul-Razzak will share responsibility for the research project Dr Culos-Reed will coordinate the overall project as well as oversee the exercise component of the intervention She has 20 years of experience working in cancer and exercise research and brings a strong background in knowledge translation to the proposed work Dr Culos-Reed will also provide in-kind support through use of her research facility Health and Wellness Lab at the University of Calgary as well as support from current graduate students and staff CEP CPTs and research coordinators affiliated with her lab Dr Abdul-Razzak will oversee the clinical implementation of the project at the TBCC including support of participant recruitment and delivery of the care by the intervention teams She has extensive training in qualitative methodology and in clinical trials research in the palliative population Several co-applicants and collaborators have been instrumental in the conceptualization of this project and bring extensive clinical expertise in oncology Bebb cancer physiatry and rehabilitation Francis Capozzi and nutrition therapy for patients with advanced cancer Dexter Gillis Walker Black This multidisciplinary team will continue to be involved in the pilot study design and delivery as well as subsequent work on the PCT
Study Participants Advanced NSCLCA patients classified as stage III or IV with self-reported symptom burden and cleared by the health care professionals HCP to engage in mild to moderate levels of physical activity PA
We will recruit n10-15 and based on current patient numbers this is a conservative expectation for the 6 month recruitment period
A subset of participants will be invited to participate in one-on-one qualitative interviews with the aim of understanding their perspectives on engaging in the study including barriers and facilitators to participation and the impact of the interventions of quality of life and symptom control A thematic analysis approach will be utilized and although an exact a priori sample size cannot be calculated we estimate that 5-10 interviews may be required in order to achieve an adequate understanding of patient perspectives ie data saturation We will use a maximum variation sampling strategy based on age gender functional status and cancer treatments All participants will be offered interviews if they consented to be contacted and sampling will occur until adequate understanding at each timepoint is achieved via the patient perspective
Intervention Components
1 Exercise The proposed exercise intervention under the direction of Drs Capozzi Culos-Reed and Francis will include a centre-based group exercise program plus home-based exercises along with behaviour change support The interventionist will be a CEP who will receive prior training on the health behaviour change support similar to that currently used within the ACE program15 The 12-week group-based exercise program consisting of 1 weekly 75 minute session of which 45 minutes are exercise and 15 minutes of yoga and the other 15 minutes includes education and facilitating the group social support will be delivered in dedicated fitness facilities located at the Holy Cross Hospital in Calgary and at the University of Calgary Forty-five minute exercise circuits will include 6 exercise stations with modifications made according to the baseline physical function of each participant The exercise circuit will be followed by a 15-minute therapeutic yoga class based on Dr Culos-Reeds Yoga Thrive program20-22 Overall the 60 minute session will include a light warm up 5-10 minutes and 6 exercise stations with a range of functional exercises designed to target both aerobic and strength components of fitness 35-40 minutes with modifications made according to physical function at the start of the program The main focus of the circuit will be on muscle strength balance flexibility and aerobic capacity as associated with beneficial daily physical function ie for activities of daily living Most group sessions will involve a series of circuit-style classes that allow for adequate group supervision as well as the ability for individuals to work at their own pace In addition to the weekly group-based class a home-based exercise prescription for an additional 1-2 sessions per week facilitated by provision of basic home-based fitness equipment and the Yoga Thrive class videos will be provided A FitBit will also be provided for the duration of the study to support physical activity behavior change and enhance safety and returned upon completion of the exercise program To reduce burden participants will not be required to report objective physical activity from the device
2 Palliative Symptom Management Palliative symptom management under the direction of Drs Abdul-Razzak and Bebb and Dr Lyle Galloway will focus on symptoms that contribute to reduced QOL eg pain fatigue nausea limit ones ability to engage in exercise or present barriers to oral intake eg pain management nausea mucositis thrush These will be delivered by the Complex Cancer Care Management team at the TBCC which includes a team of physicians a nurse practitioner advanced practice pharmacists and a nurse coordinator Clinicians will deliver pharmacologic and non-pharmacologic therapies based on their clinical judgement Participant assessments will occur in conjunction with scheduled lung cancer clinic visits cancer therapy treatment visits or as separate dedicated research visits when necessary The initial assessment will occur within two weeks of the exercise program initiation After the initial assessment follow-up consultations can occur at the discretion of the palliative care clinicians and participants and may occur either in person or by phone Clinical case report forms will be used to track the type of treatments provided during these visits for descriptive purposes
3 Nutrition The nutrition component of the intervention is designed to meet individual nutrient needs and lifestyle of participants as well as work synergistically with the previously described exercise component The study coordinator will ask participants to complete a self-administered online 24-hr dietary food recall Participants will be asked to record one weekday and one weekend day The Automated Self-Administered 24-hour ASA24 dietary assessment tool was created by the National Cancer Institute NCI and is a free web-based tool that enables multiple automatically coded self-administered 24-hour recalls httpasa24ca Participants will be provided with instructions on how to use this technology Chelsia Gillis PhD Candidate RD on the research team will consult with the TBCC Registered Dietitian RD team to develop a relevant feedback form and tailored nutrition advice based on a pre-study food recall evaluation what do you typically eat in a dayThis evaluation will assess micro- and macronutrient intake as well as individual client needs Data from this evaluation will be analyzed and managed under the leadership of Gillis who will also direct TBCC staff nutritionist on the nutrition intervention delivery within 2 weeks of study enrollment RDs involved in the study will also have the ability to recommend interventions based on the nutrition assessment feedback form such as oral nutritional supplementation or target daily protein and caloric intake The number of follow-up dietitian visits will be determined based on individual need for each participant and post-study food recall evaluation data will be collected and analyzed by Gillis with support from appropriate members of the research team to assess changes in food intake behaviours and possible correlations to levels of exercise participation and patient-reported outcomes
Data Collection We will collect demographic data and details of tumour type eg histology biomarkers and treatments received prior to and during the trial eg chemotherapy targeted therapy radiation therapy Primary outcome measures will assess study feasibility both quantitatively and qualitatively including recruitment who participate from those eligible attendance weekly group class assessment completion safety adverse event reporting attrition rates and qualitative themes generated from one-on-one participant interviews conducted at the end of the intervention We will recruit a subset of participants for the interviews using purposive sampling to achieve maximum variation based on factors that may lead to different viewpoints eg age gender lifestyle factors cancer stage treatment It is hypothesized that a weekly group-based PA intervention will be feasible for advanced NSCLC patients predicted as 30 recruitment of patients approached for participation and 60 attendance at weekly group class and 70 assessment completion and safe zero reported adverse events related to the exercise intervention
Secondary outcomes include exploratory analysis of the interventions impact on PROs including QOL including fatigue and symptom burden QOL will be measured with the FACT-general and FACT-lung and fatigue will be measured with the FACIT-fatigue The symptom burden inventory ESAS that is part of the Putting Patients First PPF assessment is collected for all patients at TBCC and will be collected from chart review It will also be collected before and after each exercise session Nutrition will be assessed from the food recall evaluation data collected pre and post intervention Physical performance modified seniors fitness test resting heart rate resting blood pressure height weight waisthip circumference sit-and-reach shoulder range of motion 30-second sit to stand handgrip strength 6-minute walk test single-leg balance activity levels self-reported Godin Leisure Time Exercise Questionnaire and opioidother drug use chart review will be assessed at baseline pre-intervention and post-intervention
PRO measures will be collected through questionnaires administered at baseline pre-intervention and post-intervention and completed either online survey monkey or in person during the clinic or exercise assessment using a hard copy of the online survey Exercise assessments will be completed at the Health and Wellness Lab Culos-Reed by a CEP not involved in the delivery of the exercise intervention Relevant medical or symptom management information will be obtained from chart review and from the case report forms collected over the duration of the 12-week intervention and stored in a secure offline database To reduce burden in this feasibility study participants will not be required to report objective physical activity from the device
Analysis Quantitative analysis will include descriptive statistics meansmedians standard deviations and dependent t-tests to measure change over time within the participants The qualitative analysis of the interviews will include verbatim transcription and input into NVivo for thematic analysis Results of both data sources analyses will be examined to provide a richer understanding of the feasibility and tolerability of the described multimodal intervention in the advanced NSCLC population
The proposed work will inform the feasibility of providing a multimodal complex care intervention to promote QOL in advanced NSCLC patients Specifically by evaluating feasibility of this intervention we aim to develop a larger trial PCT aimed at measuring the impact of a multimodal cancer rehabilitation service on QOL in numerous advanced tumour group populations
Evidence shows that physical function and physical independence are among the most important determinants of QOL for cancer patients with palliative care needs6 There is strong empirical evidence to demonstrate the positive impact of each individual modality included in the proposed intervention - symptom management nutrition and exercise - on QOL in advanced cancer populations including patients with metastatic NSCLC78 Nutritional status has been shown to be predictive of QOL in patients with cancer including in those diagnosed with inoperable NSCLC9 Exercise is also supported as beneficial for overall QOL in advanced cancer populations with particularly strong effects on physical and mental well-being10 Exercise promotes the retention and utilization of nutrients and anabolism while palliative symptom measures can help improve oral intake by ameliorating symptoms such as nausea mucositis thrush or constipation11 Palliative symptom measures may also help reduce obstacles to exercise such as pain or dyspnea that are commonly experienced by patients with advanced lung cancer Despite the promising evidence few studies have examined the effect of combining a nutrition and exercise intervention within palliative care yet preliminary data suggests synergistic effects Results from a recent randomized control trial suggest that an intervention combining nutrition and exercise components may be feasible in advanced cancer care including stage IV NSCLC care with an attrition rate of only 86 during the 3-month trial period 12 While this is promising there is still limited data on the feasibility of these interventions and there have been no RCTs to date that have combined palliative care with nutrition and exercise interventions Hall CC Cook J Maddocks M et al Combined exercise and nutritional rehabilitation in outpatients with incurable cancer a systematic review Support Care Cancer 2019 272371-2384 1314
Given the growing number of NSCLC patients entering long-term survivorship this work is critical for ensuring that the healthcare system is addressing their unique supportive and palliative care needs Our project is relevant to the present funding opportunity because of its focus on patient reported outcomes PROs We will utilize PROs that are used in AHS Putting Patients First and in the cancer population FACT-G FACT-lung and FACIT-F and will collect patient feedback qualitative interviews on the intervention recruitment and delivery This work will also help connect existing palliative resources at the Tom Baker Cancer Centre Complex Cancer Care team physiatry and nutrition along with ongoing work on the University of Calgarys Alberta Cancer Exercise ACE program15 The preliminary outcome and feasibility data will inform the sample size and characteristics for a future PCT By showing proof of concept in advanced lung cancer a disease with high patient burden we hope results from this work will facilitate further adaptation of the proposed multimodal intervention to support the palliative care needs of other tumour groups
Research Objectives
This pilot study will examine a multimodal intervention including exercise and nutrition in conjunction with palliative symptom management on the QOL of advanced NSCLC patients The impact of symptom burden on the QOL in NSCLC patients is significant and under-recognized Due to improvements in therapies there is an opportunity to address QOL in this population whose members are now on average living longer and potentially more able to engage in rehabilitation interventions This work will address a gap in research and clinical practice by providing initial data that to examine delivery of supportive and palliative cancer care to the advanced NSCLC population and provide a starting point for tailoring interventions in other tumour groups Given the novel nature of this research both in terms of the multimodal intervention as well as the focus on an underserved population the primary objective is to assess the feasibility of the intervention Secondary objectives are to obtain preliminary data on patient-reported outcomes PROs of QOL FACT-G and FACT-lung and patient functioning measures symptom measurement Putting Patients First assessment tool exercise levels and fitness outcomes
Methodology
This pilot study will involve a prospective mixed-methods design The quantitative component includes measures of study feasibility and exploratory outcome measures as described below The embedded qualitative component will use semi-structured one-on-one interviews to explore participant perspectives about intervention tolerabilityfeasibility with a focus on barriers and facilitators to participation perspectives on recruitment the type and combination of intervention modalities exercise type role of instructor and content within the palliative symptom and nutrition intervention delivery locations duration of the intervention and satisfaction with the outcome measures used The rationale for this study design follows the Medical Research Council guidelines for the evaluation of complex interventions1617 which supports the use of qualitative methods nested within a larger trial to understand the active ingredients and contextual factors that result in certain outcomes in a complex intervention study This has been used as a framework for previously published complex intervention trials in palliative care18 19 Research Team Co-Principal Investigators Culos-Reed and Abdul-Razzak will share responsibility for the research project Dr Culos-Reed will coordinate the overall project as well as oversee the exercise component of the intervention She has 20 years of experience working in cancer and exercise research and brings a strong background in knowledge translation to the proposed work Dr Culos-Reed will also provide in-kind support through use of her research facility Health and Wellness Lab at the University of Calgary as well as support from current graduate students and staff CEP CPTs and research coordinators affiliated with her lab Dr Abdul-Razzak will oversee the clinical implementation of the project at the TBCC including support of participant recruitment and delivery of the care by the intervention teams She has extensive training in qualitative methodology and in clinical trials research in the palliative population Several co-applicants and collaborators have been instrumental in the conceptualization of this project and bring extensive clinical expertise in oncology Bebb cancer physiatry and rehabilitation Francis Capozzi and nutrition therapy for patients with advanced cancer Dexter Gillis Walker Black This multidisciplinary team will continue to be involved in the pilot study design and delivery as well as subsequent work on the PCT
Study Participants Advanced NSCLCA patients classified as stage III or IV with self-reported symptom burden and cleared by the health care professionals HCP to engage in mild to moderate levels of physical activity PA
We will recruit n10-15 and based on current patient numbers this is a conservative expectation for the 6 month recruitment period
A subset of participants will be invited to participate in one-on-one qualitative interviews with the aim of understanding their perspectives on engaging in the study including barriers and facilitators to participation and the impact of the interventions of quality of life and symptom control A thematic analysis approach will be utilized and although an exact a priori sample size cannot be calculated we estimate that 5-10 interviews may be required in order to achieve an adequate understanding of patient perspectives ie data saturation We will use a maximum variation sampling strategy based on age gender functional status and cancer treatments All participants will be offered interviews if they consented to be contacted and sampling will occur until adequate understanding at each timepoint is achieved via the patient perspective
Intervention Components
1 Exercise The proposed exercise intervention under the direction of Drs Capozzi Culos-Reed and Francis will include a centre-based group exercise program plus home-based exercises along with behaviour change support The interventionist will be a CEP who will receive prior training on the health behaviour change support similar to that currently used within the ACE program15 The 12-week group-based exercise program consisting of 1 weekly 75 minute session of which 45 minutes are exercise and 15 minutes of yoga and the other 15 minutes includes education and facilitating the group social support will be delivered in dedicated fitness facilities located at the Holy Cross Hospital in Calgary and at the University of Calgary Forty-five minute exercise circuits will include 6 exercise stations with modifications made according to the baseline physical function of each participant The exercise circuit will be followed by a 15-minute therapeutic yoga class based on Dr Culos-Reeds Yoga Thrive program20-22 Overall the 60 minute session will include a light warm up 5-10 minutes and 6 exercise stations with a range of functional exercises designed to target both aerobic and strength components of fitness 35-40 minutes with modifications made according to physical function at the start of the program The main focus of the circuit will be on muscle strength balance flexibility and aerobic capacity as associated with beneficial daily physical function ie for activities of daily living Most group sessions will involve a series of circuit-style classes that allow for adequate group supervision as well as the ability for individuals to work at their own pace In addition to the weekly group-based class a home-based exercise prescription for an additional 1-2 sessions per week facilitated by provision of basic home-based fitness equipment and the Yoga Thrive class videos will be provided A FitBit will also be provided for the duration of the study to support physical activity behavior change and enhance safety and returned upon completion of the exercise program To reduce burden participants will not be required to report objective physical activity from the device
2 Palliative Symptom Management Palliative symptom management under the direction of Drs Abdul-Razzak and Bebb and Dr Lyle Galloway will focus on symptoms that contribute to reduced QOL eg pain fatigue nausea limit ones ability to engage in exercise or present barriers to oral intake eg pain management nausea mucositis thrush These will be delivered by the Complex Cancer Care Management team at the TBCC which includes a team of physicians a nurse practitioner advanced practice pharmacists and a nurse coordinator Clinicians will deliver pharmacologic and non-pharmacologic therapies based on their clinical judgement Participant assessments will occur in conjunction with scheduled lung cancer clinic visits cancer therapy treatment visits or as separate dedicated research visits when necessary The initial assessment will occur within two weeks of the exercise program initiation After the initial assessment follow-up consultations can occur at the discretion of the palliative care clinicians and participants and may occur either in person or by phone Clinical case report forms will be used to track the type of treatments provided during these visits for descriptive purposes
3 Nutrition The nutrition component of the intervention is designed to meet individual nutrient needs and lifestyle of participants as well as work synergistically with the previously described exercise component The study coordinator will ask participants to complete a self-administered online 24-hr dietary food recall Participants will be asked to record one weekday and one weekend day The Automated Self-Administered 24-hour ASA24 dietary assessment tool was created by the National Cancer Institute NCI and is a free web-based tool that enables multiple automatically coded self-administered 24-hour recalls httpasa24ca Participants will be provided with instructions on how to use this technology Chelsia Gillis PhD Candidate RD on the research team will consult with the TBCC Registered Dietitian RD team to develop a relevant feedback form and tailored nutrition advice based on a pre-study food recall evaluation what do you typically eat in a dayThis evaluation will assess micro- and macronutrient intake as well as individual client needs Data from this evaluation will be analyzed and managed under the leadership of Gillis who will also direct TBCC staff nutritionist on the nutrition intervention delivery within 2 weeks of study enrollment RDs involved in the study will also have the ability to recommend interventions based on the nutrition assessment feedback form such as oral nutritional supplementation or target daily protein and caloric intake The number of follow-up dietitian visits will be determined based on individual need for each participant and post-study food recall evaluation data will be collected and analyzed by Gillis with support from appropriate members of the research team to assess changes in food intake behaviours and possible correlations to levels of exercise participation and patient-reported outcomes
Data Collection We will collect demographic data and details of tumour type eg histology biomarkers and treatments received prior to and during the trial eg chemotherapy targeted therapy radiation therapy Primary outcome measures will assess study feasibility both quantitatively and qualitatively including recruitment who participate from those eligible attendance weekly group class assessment completion safety adverse event reporting attrition rates and qualitative themes generated from one-on-one participant interviews conducted at the end of the intervention We will recruit a subset of participants for the interviews using purposive sampling to achieve maximum variation based on factors that may lead to different viewpoints eg age gender lifestyle factors cancer stage treatment It is hypothesized that a weekly group-based PA intervention will be feasible for advanced NSCLC patients predicted as 30 recruitment of patients approached for participation and 60 attendance at weekly group class and 70 assessment completion and safe zero reported adverse events related to the exercise intervention
Secondary outcomes include exploratory analysis of the interventions impact on PROs including QOL including fatigue and symptom burden QOL will be measured with the FACT-general and FACT-lung and fatigue will be measured with the FACIT-fatigue The symptom burden inventory ESAS that is part of the Putting Patients First PPF assessment is collected for all patients at TBCC and will be collected from chart review It will also be collected before and after each exercise session Nutrition will be assessed from the food recall evaluation data collected pre and post intervention Physical performance modified seniors fitness test resting heart rate resting blood pressure height weight waisthip circumference sit-and-reach shoulder range of motion 30-second sit to stand handgrip strength 6-minute walk test single-leg balance activity levels self-reported Godin Leisure Time Exercise Questionnaire and opioidother drug use chart review will be assessed at baseline pre-intervention and post-intervention
PRO measures will be collected through questionnaires administered at baseline pre-intervention and post-intervention and completed either online survey monkey or in person during the clinic or exercise assessment using a hard copy of the online survey Exercise assessments will be completed at the Health and Wellness Lab Culos-Reed by a CEP not involved in the delivery of the exercise intervention Relevant medical or symptom management information will be obtained from chart review and from the case report forms collected over the duration of the 12-week intervention and stored in a secure offline database To reduce burden in this feasibility study participants will not be required to report objective physical activity from the device
Analysis Quantitative analysis will include descriptive statistics meansmedians standard deviations and dependent t-tests to measure change over time within the participants The qualitative analysis of the interviews will include verbatim transcription and input into NVivo for thematic analysis Results of both data sources analyses will be examined to provide a richer understanding of the feasibility and tolerability of the described multimodal intervention in the advanced NSCLC population
The proposed work will inform the feasibility of providing a multimodal complex care intervention to promote QOL in advanced NSCLC patients Specifically by evaluating feasibility of this intervention we aim to develop a larger trial PCT aimed at measuring the impact of a multimodal cancer rehabilitation service on QOL in numerous advanced tumour group populations
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