Lung CancerTELErpNCT02716493
Feasibility of a 8-week Telerehabilitation Program for Patients With Thoracic Neoplasia Receiving Chemotherapy
A study testing Telerehabilitation program in people with Lung Cancer, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Telerehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Eight-week Telerehabilitation Program for Patients With Unresectable Thoracic Neoplasia Receiving Chemotherapy
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
- Conditions
- Lung Cancer
- Being tested
- Telerehabilitation program
- Keywords
- Telerehabilitation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation programBehavioural
The intervention was an 8-week home-based telerehabilitation program (three sessions of about 75 minutes per week) using the eChez-Soi telerehabilitation platform.
Through a unique software interface, the eChez-Soi allows for the following three technological aspects: 1- continuous data acquisition and recording from commercial biometric sensors; 2- continuous transmission of the collected data via the Internet to the clinician's computer, allowing the clinician to visualize the biomechanical and physiological parameters in real time; and 3- a challenging gaming environment with interactive exercises performed on musical rhythms.
In total, 15 supervised sessions and 9 unsupervised sessions were planned for a total of 24 exercise sessions
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group | Experimental | Patients with unresectable thoracic neoplasia receiving chemotherapy treatment Receives: Behavioral: Telerehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events during the 8-week telerehabilitation program
Measured: Along the 8-week program
Adherence of the participants to the 8-week telerehabilitation program.
Adherence was defined as the number of sessions done over the prescribed sessions (supervised and unsupervised) and as percentage of time spent within the target heart rate range (intensities) throughout the cardiovascular exercise sessions
Measured: Along the 8-week program
Participants satisfaction with the telerehabilitation platform with the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0)
The satisfaction of the patients was evaluated using a questionnaire adapted from the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0) that calculates both satisfaction scores for technological aspects and services. It consists of 12 items rated on a scale from 1 to 5 (1: not satisfied at all to 5: very satisfied).
Measured: At the end of the 8-week telerehabilitation program
User satisfaction with health services received with the French version of the Health Care Satisfaction Questionnaire
To assess more specifically the user satisfaction with health services received, we used the French version of the Health Care Satisfaction Questionnaire. This is a 26-item questionnaire answered on a four-point Likert scale, where ''1'' represents ''not at all satisfied'' and ''4'' represents ''highly satisfied". The total score is calculated in percentage and can be computed as the mean overall satisfaction divided in three domains: i) relationship with the professional, ii) delivery of services and iii) organization of services. Higher scores indicate a higher level of satisfaction.
Measured: At the end of the 8-week telerehabilitation program
Secondary outcomes (13)
Cardiopulmonary maximal exercise test (CPET)
Measured: At baseline and following the 8-week program
Constant workrate cycle exercise test at 80% of the maximal capacity of the patient
Measured: At baseline and following the 8-week program
Isokinetic quadriceps muscle functions
Quadriceps muscle function (strength and endurance) was assessed during an isokinetic endurance test performed at a rate of 30 repetitions at 90°/sec of angular velocity (Biodex, system pro 4, Biodex Medical System, 20 Ramsay Road, Shirley, New York )
Measured: At baseline and following the 8-week program
Lean body mass
Lean body mass (in Kg) were measured by bioelectrical impedance analysis (TBF-300WA Tanita, Arlington Heights, IL, USA)
Measured: At baseline and following the 8-week program
Fat body mass
Fat body mass (in Kg) were measured by bioelectrical impedance analysis (TBF-300WA Tanita, Arlington Heights, IL, USA)
Measured: At baseline and following the 8-week program
Weight
Weight (in Kg) of the patient
Measured: At baseline and following the 8-week program
Height
Height (in meters) of the patient
Measured: At baseline and following the 8-week program
Timed up and go test
Measured: At baseline and following the 8-week program
Timed stairs test
Measured: At baseline and following the 8-week program
Distance achieved during the 6 minutes walking test
Measured: At baseline and following the 8-week program
Cancer specific quality of life with the self-reported European Organization for Research and Treatment of Cancer Quality of Life Questionnaire questionnaire
The cancer related quality of life was assessed using the self-reported European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) including the lung cancer specific questionnaire QLQ-LC13
Measured: At baseline and following the 8-week program
Anxiety and depression with the Hospital Anxiety and Depression Scale questionnaire
The French Canadian version of the Hospital Anxiety and Depression Scale (HADS) was used to identify patients suffering of anxiety disorders or depression
Measured: At baseline and following the 8-week program
Nutritional status with the mini-nutritional assessment
Measured: At baseline and following the 8-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startNov 2013
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didier Saey, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716493
- Sponsor's protocol ID
- 20994
- Acronym
- TELErp
- Status last verified
- Jan 2017
- First submitted
- 10 Mar 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Eight-week Telerehabilitation Program for Patients With Unresectable Thoracic Neoplasia Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT02716493
- Acronym / sponsor ID
- TELErp / 20994
- Conditions
- Lung Cancer
- Keywords
- Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de QuebecUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 23 Mar 2016 (estimated)
- 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.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group | Experimental | Behavioral: Telerehabilitation programPatients with unresectable thoracic neoplasia receiving chemotherapy treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Telerehabilitation programThe intervention was an 8-week home-based telerehabilitation program (three sessions of about 75 minutes per week) using the eChez-Soi telerehabilitation platform. Through a unique software interface, the eChez-Soi allows for the following three technological aspects: 1- continuous data acquisition and recording from commercial biometric sensors; 2- continuous transmission of the collected data via the Internet to the clinician's computer, allowing the clinician to visualize the biomechanical and physiological parameters in real time; and 3- a challenging gaming environment with interactive exercises performed on musical rhythms. In total, 15 supervised sessions and 9 unsupervised sessions were planned for a total of 24 exercise sessions | Behavioural | Telerehabilitation group |
Primary outcome
Number of adverse events during the 8-week telerehabilitation program
Time frame: Along the 8-week program
Adherence of the participants to the 8-week telerehabilitation program.
Time frame: Along the 8-week program
Adherence was defined as the number of sessions done over the prescribed sessions (supervised and unsupervised) and as percentage of time spent within the target heart rate range (intensities) throughout the cardiovascular exercise sessions
Participants satisfaction with the telerehabilitation platform with the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0)
Time frame: At the end of the 8-week telerehabilitation program
The satisfaction of the patients was evaluated using a questionnaire adapted from the Québec User Evaluation of Satisfaction with Assistive Technology questionnaire (QUEST 2.0) that calculates both satisfaction scores for technological aspects and services. It consists of 12 items rated on a scale from 1 to 5 (1: not satisfied at all to 5: very satisfied).
User satisfaction with health services received with the French version of the Health Care Satisfaction Questionnaire
Time frame: At the end of the 8-week telerehabilitation program
To assess more specifically the user satisfaction with health services received, we used the French version of the Health Care Satisfaction Questionnaire. This is a 26-item questionnaire answered on a four-point Likert scale, where ''1'' represents ''not at all satisfied'' and ''4'' represents ''highly satisfied". The total score is calculated in percentage and can be computed as the mean overall satisfaction divided in three domains: i) relationship with the professional, ii) delivery of services and iii) organization of services. Higher scores indicate a higher level of satisfaction.
13 secondary outcomes
Cardiopulmonary maximal exercise test (CPET)
Time frame: At baseline and following the 8-week program
Constant workrate cycle exercise test at 80% of the maximal capacity of the patient
Time frame: At baseline and following the 8-week program
Isokinetic quadriceps muscle functions
Time frame: At baseline and following the 8-week program
Lean body mass
Time frame: At baseline and following the 8-week program
Fat body mass
Time frame: At baseline and following the 8-week program
Weight
Time frame: At baseline and following the 8-week program
Height
Time frame: At baseline and following the 8-week program
Timed up and go test
Time frame: At baseline and following the 8-week program
Timed stairs test
Time frame: At baseline and following the 8-week program
Distance achieved during the 6 minutes walking test
Time frame: At baseline and following the 8-week program
Cancer specific quality of life with the self-reported European Organization for Research and Treatment of Cancer Quality of Life Questionnaire questionnaire
Time frame: At baseline and following the 8-week program
Anxiety and depression with the Hospital Anxiety and Depression Scale questionnaire
Time frame: At baseline and following the 8-week program
Nutritional status with the mini-nutritional assessment
Time frame: At baseline and following the 8-week program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation program in people with Lung Cancer, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events during the 8-week telerehabilitation program (time frame: Along the 8-week program). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2017.