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NCT Number: NCT06354959

Prehab for Lung and Esophageal Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victoria General Hospital

Halifax, Nova Scotia, Canada

Location status: Recruiting

Location contact

Jodi Langley

CONTACT

[email protected]

902-473-2035

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation

Behavioral

8-week community based prehab program

Primary outcomes

  1. Feasibility- Recruitment

    Time frame: 2 years

    Participant accrual as defined as the number of eligible participants who consent to participate

  2. Feasibility- Participant fidelity

    Time frame: 2 years

    Participant adherence to prescribed exercise intervention

  3. Feasibility - Safety

    Time frame: 2 years

    Adverse and serious adverse events

  4. Feasibility - Retention/Attrition

    Time frame: 2 years

    Percentage of participants who complete the 12-week intervention

  5. Feasibility - Participant Experience

    Time frame: 2 years

    Exit interview is used to assess factors influencing participant selection of intervention type/setting, adherence to and satisfaction with the health coaching program

  6. Feasibility- Attendance

    Time frame: 2 years

    Attendance is calculated as the percentage of exercise sessions completed by the total number of available exercise sessions over the 8-10-week intervention.

Secondary outcomes

  1. Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E)

    Time frame: 8-10 week change

    44 item that measures multidimensional quality of life

  2. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Time frame: 8-10 week change

    a 13-item questionnaire that evaluates an individual's self-reported fatigue during their usual daily activities over the past week

  3. 5x chair stand

    Time frame: 8-10 week change

    To test functional strengths, risk of falling and overall leg strength and endurance

  4. Stair climb test

    Time frame: 8-10 week change

    To test functional strength, balance and agility

  5. Grip strength

    Time frame: 8-10 week change

    To test overall body strength

  6. Resting Heart rate

    Time frame: 8-10 week change

    Resting heart rate

  7. Resting blood pressure

    Time frame: 8-10 week change

    resting systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Collaborators

  • Dalhousie University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 9, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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