NCT06354959

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2024Jan 2027

First Submitted

Initial submission to the registry

February 21, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

August 23, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

February 21, 2024

Last Update Submit

August 21, 2024

Conditions

Neoplasm of LungNeoplasmsExerciseSurgery

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

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

    8-10 week change

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

    8-10 week change

  • 5x chair stand

    8-10 week change

  • Stair climb test

    8-10 week change

  • Grip strength

    8-10 week change

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Receive standard of care

Prehab

EXPERIMENTAL

Complete an 8-week community based prehab program.

Behavioral: Prehabilitation

Interventions

PrehabilitationBEHAVIORAL

8-week community based prehab program

Prehab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Not able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria General Hospital

Halifax, Nova Scotia, Canada

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40063931DERIVED

MeSH Terms

Conditions

Lung NeoplasmsNeoplasmsMotor Activity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesBehavior

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2024

First Posted

April 9, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

August 23, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)