Prehab for Lung and Esophageal Cancer

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06354959
• Other study ID #: 1030020
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: April 2024
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: January 1, 2027
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Exercise
• Lung Neoplasms
• Neoplasm of Lung
• Neoplasms
• Surgery

Intervention

Behavioral:
• Prehabilitation
8-week community based prehab program

Locations

Country	Name	City	State
Canada	Victoria General Hospital	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Dalhousie University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility- Recruitment	Participant accrual as defined as the number of eligible participants who consent to participate	2 years
Primary	Feasibility- Participant fidelity	Participant adherence to prescribed exercise intervention	2 years
Primary	Feasibility - Safety	Adverse and serious adverse events	2 years
Primary	Feasibility - Retention/Attrition	Percentage of participants who complete the 12-week intervention	2 years
Primary	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
Primary	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	Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E)	44 item that measures multidimensional quality of life	8-10 week change
Secondary	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
Secondary	5x chair stand	To test functional strengths, risk of falling and overall leg strength and endurance	8-10 week change
Secondary	Stair climb test	To test functional strength, balance and agility	8-10 week change
Secondary	Grip strength	To test overall body strength	8-10 week change
Secondary	Resting Heart rate	Resting heart rate	8-10 week change
Secondary	Resting blood pressure	resting systolic and diastolic blood pressure	8-10 week change