Prehab for Lung and Esophageal Cancer

Prehab for Lung and Esophageal Cancer: Optimizing Well-being for Better Outcomes

Research indicates that individuals diagnosed with lung or esophageal cancer who enter treatment with higher functional capacities, improved body composition, and better nutrition status tend to experience better outcomes and a higher quality of life. The primary objective of a prehabilitation health coaching program is to enhance the overall health and well-being of patients before they undergo major surgery.This personalized 8-week program encompasses elements such as nutrition, smoking cessation, sleep hygiene, and movement, equipping participants with the knowledge and tools needed to adopt healthier lifestyles.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Exercise; Surgery; Neoplasm of Lung
• Intervention / Treatment: Behavioral: Prehabilitation

Detailed Description

The purpose of this study is to explore the implementation, feasibility and effectiveness of a community-based prehabilitation health coaching program, including nutrition, smoking cessation, sleep hygiene and movement for individuals scheduled to undergo surgery for lung or esophageal cancer.. Participants will have the option to engage in a one-on-one prehabilitation health coaching program tailored to their needs, led by a Qualified Exercise Professional (QEP). The personalized prehabilitation plan will encompass 4-6 in-person or virtual meetings before surgery, including a structured movement plan, education on smoking cessation, sleep quality, stress reduction, mindfulness, and nutrition. Post-surgery, the QEP will provide support through counselling and scheduled sessions for a month after surgery and include one session while the patient is in hospital.

This research adopts a repeated measure, mixed-methods approach. Participants will undergo three clinical assessments at different stages: baseline, pre-surgery, and 4-6 weeks post-surgery. The findings from this study will guide future grant applications aimed at funding larger studies and the implementation of prehabilitation as part of standard of care in lung and esophageal cancer patients in Nova Scotia.

Central to the research endeavor is the driving question: "How can a community-based prehabilitation program be successfully implemented in the community, and can it lead to improved functional outcomes in patients undergoing surgery for lung or esophageal cancer?" This overarching question provides the study with its core focus and serves as a guiding force throughout the research process.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Recruiting
      • Victoria General Hospital
      • Contact: Jodi Langley; Phone Number: 902-473-2035; Email: jodi.langley@dal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with lung or esophageal cancer
• Scheduled to receive surgical intervention in minimum 2-weeks
• Surgeon approval
• Able to read and write in English
• >18 years of age

Exclusion Criteria:

• Not able to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Receive standard of care
Experimental: Prehab; Complete an 8-week community based prehab program.	Behavioral: Prehabilitation; 8-week community based prehab program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility- Recruitment	Participant accrual as defined as the number of eligible participants who consent to participate	2 years
Feasibility- Participant fidelity	Participant adherence to prescribed exercise intervention	2 years
Feasibility - Safety	Adverse and serious adverse events	2 years
Feasibility - Retention/Attrition	Percentage of participants who complete the 12-week intervention	2 years
Feasibility - Participant Experience	Exit interview is used to assess factors influencing participant selection of intervention type/setting, adherence to and satisfaction with the health coaching program	2 years
Feasibility- Attendance	Attendance is calculated as the percentage of exercise sessions completed by the total number of available exercise sessions over the 8-10-week intervention.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E)	44 item that measures multidimensional quality of life	8-10 week change
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	a 13-item questionnaire that evaluates an individual's self-reported fatigue during their usual daily activities over the past week	8-10 week change
5x chair stand	To test functional strengths, risk of falling and overall leg strength and endurance	8-10 week change
Stair climb test	To test functional strength, balance and agility	8-10 week change
Grip strength	To test overall body strength	8-10 week change
Resting Heart rate	Resting heart rate	8-10 week change
Resting blood pressure	resting systolic and diastolic blood pressure	8-10 week change

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: Dalhousie University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms; Lung Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: 1030020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No