Neoplasm of LungNCT06354959
Prehab for Lung and Esophageal Cancer
A study testing Prehabilitation in people with Neoplasm of Lung and Neoplasms, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm of Lung, Neoplasms, Exercise
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not able to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Victoria General Hospital
Halifax, Nova Scotia
Jodi Langley, 902-473-2035, jodi.langley@dal.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Neoplasm of Lung, Neoplasms, Exercise, Surgery
- Being tested
- Prehabilitation
- Medical subject headings
- Lung Neoplasms, Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
8-week community based prehab program
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Receive standard of care |
| Prehab | Experimental | Complete an 8-week community based prehab program. Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Recruitment
Participant accrual as defined as the number of eligible participants who consent to participate
Measured: 2 years
Feasibility- Participant fidelity
Participant adherence to prescribed exercise intervention
Measured: 2 years
Feasibility - Safety
Adverse and serious adverse events
Measured: 2 years
Feasibility - Retention/Attrition
Percentage of participants who complete the 12-week intervention
Measured: 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
Measured: 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.
Measured: 2 years
Secondary outcomes (7)
Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E)
44 item that measures multidimensional quality of life
Measured: 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
Measured: 8-10 week change
5x chair stand
To test functional strengths, risk of falling and overall leg strength and endurance
Measured: 8-10 week change
Stair climb test
To test functional strength, balance and agility
Measured: 8-10 week change
Grip strength
To test overall body strength
Measured: 8-10 week change
Resting Heart rate
Resting heart rate
Measured: 8-10 week change
Resting blood pressure
resting systolic and diastolic blood pressure
Measured: 8-10 week change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm of LungStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354959
- Sponsor's protocol ID
- 1030020
- Status last verified
- Aug 2024
- First submitted
- 21 Feb 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langley JE, Sibley D, Chiekwe J, Keats MR, Snow S, Purcell J, Sollows S, Hill L, Watton D, Gaudry AE, Hashish I, Wallace A. Prehabilitation Program for Lung and Esophageal Cancers (Boosting Recovery and Activity Through Early Wellness): Protocol for a Nonrandomized Trial. JMIR Res Protoc. 2025 Mar 10;14:e60791. doi: 10.2196/60791.
PubMed 40063931
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehab for Lung and Esophageal Cancer: Optimizing Well-being for Better Outcomes
- ClinicalTrials.gov ID
- NCT06354959
- Acronym / sponsor ID
- 1030020
- Conditions
- Neoplasm of Lung, Neoplasms, Exercise, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Receive standard of care |
| Prehab | Experimental | Behavioral: PrehabilitationComplete an 8-week community based prehab program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Not able to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation8-week community based prehab program | Behavioural | Prehab |
Primary outcome
Feasibility- Recruitment
Time frame: 2 years
Participant accrual as defined as the number of eligible participants who consent to participate
Feasibility- Participant fidelity
Time frame: 2 years
Participant adherence to prescribed exercise intervention
Feasibility - Safety
Time frame: 2 years
Adverse and serious adverse events
Feasibility - Retention/Attrition
Time frame: 2 years
Percentage of participants who complete the 12-week intervention
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
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.
7 secondary outcomes
Functional Assessment of Cancer Therapy - Lung OR Esophageal (FACT-L/ FACT- E)
Time frame: 8-10 week change
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: 8-10 week change
5x chair stand
Time frame: 8-10 week change
Stair climb test
Time frame: 8-10 week change
Grip strength
Time frame: 8-10 week change
Resting Heart rate
Time frame: 8-10 week change
Resting blood pressure
Time frame: 8-10 week change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 40063931Langley JE, Sibley D, Chiekwe J, Keats MR, Snow S, Purcell J, Sollows S, Hill L, Watton D, Gaudry AE, Hashish I, Wallace A. Prehabilitation Program for Lung and Esophageal Cancers (Boosting Recovery and Activity Through Early Wellness): Protocol for a Nonrandomized Trial. JMIR Res Protoc. 2025 Mar 10;14:e60791. doi: 10.2196/60791.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Neoplasm of Lung and Neoplasms, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- Recruitment (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06354959, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.