Exercise, Nutrition, and Palliative Care in Advanced Lung Cancer (ENPAL)

NCT04575831 | Completed

• 1 other identifier: HREBA.CC-18-0681
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Advanced Lung Cancer

Keywords

Physical Activity; Nutrition; Palliative Symptom Management; Supportive Care

Outcome Measures

Primary Outcomes (7)

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

  Percentage of those who participate from eligible patients approached

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

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

  Percentage of classes attended from those offered to participants

  0-12 weeks

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

  Percentage of possible assessments that could be completed as planned

  At 0 weeks (baseline)

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

  Percentage of possible assessments that could be completed as planned

  At 12 weeks (post-intervention)

• Safety of intervention

  Record of any adverse events related to the intervention

  0-12 weeks

• Attrition Rate

  Number of participants who consent but do not complete the intervention

  0-12 weeks

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

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

  Conducted between week 12-14

Secondary Outcomes (8)

• Change in Physical Activity

  Change from baseline Physical Activity at 12 weeks (2 related measurements: directly before and after intervention)

• Change in Symptom Burden

  Change from baseline symptom burden 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)

• 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)

Study Arms (1)

Intervention

EXPERIMENTAL

The intervention arm will receive a 12-week multimodal intervention featuring exercise, nutrition, and palliative symptom management.

Behavioral: Exercise, Nutrition, and Palliative Symptom Management

Interventions

Exercise, Nutrition, and Palliative Symptom Management BEHAVIORAL

1. Exercise: The exercise intervention is a 12-week group-based program, with 1 weekly 75 minute session focused on strength, balance, flexibility and aerobic capacity. 2. Palliative Symptom Management: Palliative symptom management will focus on symptoms that contribute to reduced QOL, limit ability to engage in exercise, or present barriers to oral intake. 3. Nutrition: A Registered Dietitian (RD) team will provide feedback and tailored nutrition advice based on a pre-study food recall evaluation, recommending interventions based on the nutrition assessment feedback form, such as oral nutritional supplementation or target daily protein and caloric intake.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Tom Baker Cancer Centre: collaborator

Study Sites (1)

Faculty of Kinesiology University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

• Ester M, Culos-Reed SN, Abdul-Razzak A, Daun JT, Duchek D, Francis G, Bebb G, Black J, Arlain A, Gillis C, Galloway L, Capozzi LC. Feasibility of a multimodal exercise, nutrition, and palliative care intervention in advanced lung cancer. BMC Cancer. 2021 Feb 13;21(1):159. doi: 10.1186/s12885-021-07872-y.

  PMID: 33581739 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Nutritional Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Nicole Culos-Reed, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm feasibility study of multimodal intervention

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: October 5, 2020
• Study Start: September 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-09

Locations

CA (1)