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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 tolerability/feasibility 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 (e.g., age, gender, lung cancer type/stage, 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.
Full description
Lung cancer is the most commonly diagnosed cancer in Canada, and is the leading cause of death from cancer.1 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 QOL.2 In addition, the toxicities of traditional chemotherapies, such as the reduction of lean muscle mass3,4,5, 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 needs.6 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 NSCLC.7,8 Nutritional status has been shown to be predictive of QOL in patients with cancer, including in those diagnosed with inoperable NSCLC.9 Exercise is also supported as beneficial for overall QOL in advanced cancer populations, with particularly strong effects on physical and mental well-being.10 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 constipation.11 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; 27:2371-2384) .13,14
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 Calgary's Alberta Cancer Exercise (ACE) program.15 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 tolerability/feasibility, 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 interventions16,17 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 care.18, 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 n=10-15, 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 (i.e., 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:
Data Collection: We will collect demographic data and details of tumour type (e.g., histology, biomarkers) and treatments received prior to and during the trial (e.g., 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 (e.g., 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 intervention's 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 senior's fitness test: resting heart rate, resting blood pressure, height, weight, waist/hip 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 opioid/other 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 (means/medians, 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.
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Data sourced from clinicaltrials.gov
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