Clinical trial NCT06354959: Prehab for Lung and Esophageal Cancer
Official title: Prehab for Lung and Esophageal Cancer: Optimizing Well-being for Better Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasm of Lung
Neoplasms
Exercise
Surgery
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2024-04-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility- Recruitment
timeFrame: 2 years
measure: Feasibility- Participant fidelity
timeFrame: 2 years
measure: Feasibility - Safety
timeFrame: 2 years
measure: Feasibility - Retention/Attrition
timeFrame: 2 years
measure: Feasibility - Participant Experience
timeFrame: 2 years
measure: Feasibility- Attendance
timeFrame: 2 years
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E)
timeFrame: 8-10 week change
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: 8-10 week change
measure: 5x chair stand
timeFrame: 8-10 week change
measure: Stair climb test
timeFrame: 8-10 week change
measure: Grip strength
timeFrame: 8-10 week change
measure: Resting Heart rate
timeFrame: 8-10 week change
measure: Resting blood pressure
timeFrame: 8-10 week change
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Victoria General Hospital
state: Nova Scotia
Study officials:
References: