Clinical trial NCT02716493: Feasibility of a 8-week Telerehabilitation Program for Patients With Thoracic Neoplasia Receiving Chemotherapy
Official title: Feasibility of an Eight-week Telerehabilitation Program for Patients With Unresectable Thoracic Neoplasia Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Telerehabilitation
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Exercise-based rehabilitation improves physical function, fatigue and quality of life in patients with thoracic neoplasia. Consequently, the need for rehabilitation across the continuum of care in oncology is growing rapidly. However, the implementation of this type of intervention is limited because of many barriers such as patients' symptoms and poor accessibility to programs. In this context, healthcare systems should develop and implement new approaches to dispense these services. Consequently, telerehabilitation is a promising strategy to improve access and adherence to rehabilitation.

OBJECTIVES To investigate the feasibility, adherence and satisfaction of a home-based telerehabilitation program (TELERP) with real-time physiological parameters acquisition in patients with unresectable thoracic neoplasia receiving chemotherapy and to explore its effects on patients' functional capacity.

METHODS Five patients receiving chemotherapy followed an 8-week TELERP using real-time monitoring combined with interactive exercises. The TELERP included supervised (15) and unsupervised (9) strengthening and cardiovascular exercise sessions at a rate of 3 sessions/week. The feasibility of the TELERP, adverse outcomes, technical issues, program adherence and satisfaction were analysed. Prior to and after the program, a six-minute walking test (6MWT), a timed up and go (TUG) and a timed stair test (TST) were done to assess functional capacity


Eligibility criteria: Inclusion Criteria:

* Patients had to have an ECOG functional status of 0 (Asymptomatic) or 1 (Symptomatic but completely ambulatory);
* Have a sufficient understanding of verbal and written French instructions
* Live in a geographic region served by a high speed Internet connection.

Exclusion Criteria:

* oxygen pulsed saturation (SpO2) \<80% during the cardiopulmonary exercise test
* contraindications to exercise testing according to the American Thoracic Society and American College of Chest Physicians Exercise Testing Guidelines
* cerebral or bone metastasis
* a history of significant cardiovascular disease, hypertension, diabetes or musculoskeletal concerns that might limit their ability to perform active exercises
* severe psychiatric illness compromising adherence to the rehabilitation training routine.

Primary outcomes:
measure: Number of adverse events during the 8-week telerehabilitation program
timeFrame: Along the 8-week program
measure: Adherence of the participants to the 8-week telerehabilitation program.
timeFrame: Along the 8-week program
measure: Participants satisfaction with the telerehabilitation platform with the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0)
timeFrame: At the end of the 8-week telerehabilitation program
measure: User satisfaction with health services received with the French version of the Health Care Satisfaction Questionnaire
timeFrame: At the end of the 8-week telerehabilitation program
Secondary outcomes:
measure: Cardiopulmonary maximal exercise test (CPET)
timeFrame: At baseline and following the 8-week program
measure: Constant workrate cycle exercise test at 80% of the maximal capacity of the patient
timeFrame: At baseline and following the 8-week program
measure: Isokinetic quadriceps muscle functions
timeFrame: At baseline and following the 8-week program
measure: Lean body mass
timeFrame: At baseline and following the 8-week program
measure: Fat body mass
timeFrame: At baseline and following the 8-week program
measure: Weight
timeFrame: At baseline and following the 8-week program
measure: Height
timeFrame: At baseline and following the 8-week program
measure: Timed up and go test
timeFrame: At baseline and following the 8-week program
measure: Timed stairs test
timeFrame: At baseline and following the 8-week program
measure: Distance achieved during the 6 minutes walking test
timeFrame: At baseline and following the 8-week program
measure: Cancer specific quality of life with the self-reported European Organization for Research and Treatment of Cancer Quality of Life Questionnaire questionnaire
timeFrame: At baseline and following the 8-week program
measure: Anxiety and depression with the Hospital Anxiety and Depression Scale questionnaire
timeFrame: At baseline and following the 8-week program
measure: Nutritional status with the mini-nutritional assessment
timeFrame: At baseline and following the 8-week program
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: CRIUCPQ
Study officials:
References: