跳至主要内容
临床试验/NCT04575831
NCT04575831已完成不适用

The Feasibility of an Exercise and Nutrition Supportive Care (Palliative) Intervention for Advanced Non-small-cell Lung Cancer

University of Calgary2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Feasibility of recruitment: Percentage of those who participate from eligible patients approached

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Hemoglobin level of ≥80g/L as measured within 30 days of enrollment
  • Life expectancy >6 months (as judged by most responsible physician)

排除标准

  • Active infections at the time of enrollment
  • Enteral tube feeding/parenteral nutrition
  • Mechanical of functional bowel obstruction due to any cause
  • Cognitive impairment
  • Non-English speaking

结局指标

主要结局

Feasibility of recruitment: Percentage of those who participate from eligible patients approached

时间窗: From 3 months pre-intervention to intervention start (week 0)

Percentage of those who participate from eligible patients approached

Feasibility of assessment: Percentage of possible assessments that could be completed as planned

时间窗: At 12 weeks (post-intervention)

Percentage of possible assessments that could be completed as planned

Feasibility of attendance: Percentage of classes attended from those offered to participants

时间窗: 0-12 weeks

Percentage of classes attended from those offered to participants

Qualitative Feasibility: semi-structured one-on-one interviews

时间窗: Conducted between week 12-14

Participant perception of intervention feasibility via semi-structured one-on-one interviews (qualitative data, not reported on a scale)

Safety of intervention

时间窗: 0-12 weeks

Record of any adverse events related to the intervention

Attrition Rate

时间窗: 0-12 weeks

Number of participants who consent but do not complete the intervention

次要结局

  • Change in Symptom Burden(Change from baseline symptom burden at 12 weeks (2 related measurements: directly before and after intervention))
  • Change in Physical Function(Change from baseline to 12 weeks (2 related measurements: directly before and after intervention))
  • Change in Physical Activity(Change from baseline Physical Activity at 12 weeks (2 related measurements: directly before and after intervention))
  • Change in Lung Cancer Quality of Life(Change from baseline quality of life at 12 weeks (2 related measurements: directly before and after intervention))
  • Acute Energy(0-12 weeks (throughout intervention))
  • Acute Fatigue(0-12 weeks (throughout intervention))
  • Change in Fatigue(Change from baseline fatigue at 12 weeks (2 related measurements: directly before and after intervention))
  • Acute Symptom Burden(0-12 weeks (throughout intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验