CancerNCT05363150
Feasibility of a Smart Device Application for Home-based Prehabilitation
An observational study of Cancer and Prehabilitation, run by Seoul National University Hospital.
Trial summary
To investigate the feasibility of a home-based exercise training program using a smartphone application in patients planning for cancer surgery, and to determine the effectiveness of this application on functional capacity. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Cancer, Prehabilitation
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 1 Dec 2022
- Phase
- Observational
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visits preoperative evaluation clinic for preoperative counseling before the cancer surgery
Who may be able to join
- Adult patients (19-70) who are scheduled for elective cancer surgery
- American Society of Anesthesiologists (ASA) physical status classification I or II
- Patients who can use a smartphone application
- Patients who can perform an exercise program for at least 3 weeks from the first visit to the preoperative clinic to elective surgery
Who cannot join
- Patients who are unable to communicate
- Patients under the age of 19 and over 70
- Patients who have a major medical or psychiatric disorder that is expected to affect exercise
- Patients with contraindications to the general rehabilitation program
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility of a Smart Device Application for Home-based Prehabilitation in Patients Undergoing Lung Cancer Surgery: A Prospective Observational Pilot Study
To investigate the feasibility of a home-based exercise training program using a smartphone application in patients planning for cancer surgery, and to determine the effectiveness of this application on functional capacity.
- Conditions
- Cancer, Prehabilitation
- Keywords
- Cancer patient, Cancer Surgery, Prehabilitation
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance of a smartphone application
Based on the data saved in the application, when the program started and ended, how many steps and distance the patient exercised per day, how many sets patient did muscle exercise per day and week will be collected to calculate the compliance.
Measured: A day before surgery at ward
Satisfaction of a smartphone application
Using the questionnaire that we made to evaluation the satisfaction of a smartphone application.
Measured: A day before surgery at ward
Secondary outcomes (2)
Korean-EORTC QLQ C-30
EORTC QLQ C-30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires Core-30
A questionnaire which is designed to assess the different aspects that define the QoL of cancer patients. (Total score ranging 0 to 100, A high score for a functional scale represents a high level of functioning)
Measured: 4 weeks before the surgery at clinic, a day before the surgery at ward
6-minute walk test
The distance that patient can walk during 6 minutes.
Measured: 4 weeks before the surgery at clinic, a day before the surgery at ward
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susie Yoon, Seoul National University Hospital
- Investigators
- Susie Yoon, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363150
- Sponsor's protocol ID
- Prehab_app
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 11 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Smart Device Application for Home-based Prehabilitation in Patients Undergoing Lung Cancer Surgery: A Prospective Observational Pilot Study
- ClinicalTrials.gov ID
- NCT05363150
- Acronym / sponsor ID
- Prehab_app
- Conditions
- Cancer, Prehabilitation
- Keywords
- Cancer patient, Cancer Surgery, Prehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 5 May 2022 (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.
To investigate the feasibility of a home-based exercise training program using a smartphone application in patients planning for cancer surgery, and to determine the effectiveness of this application on functional capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visits preoperative evaluation clinic for preoperative counseling before the cancer surgery
Key inclusion criteria (4 listed)
- Adult patients (19-70) who are scheduled for elective cancer surgery
- American Society of Anesthesiologists (ASA) physical status classification I or II
- Patients who can use a smartphone application
- Patients who can perform an exercise program for at least 3 weeks from the first visit to the preoperative clinic to elective surgery
Key exclusion criteria (4 listed)
- Patients who are unable to communicate
- Patients under the age of 19 and over 70
- Patients who have a major medical or psychiatric disorder that is expected to affect exercise
- Patients with contraindications to the general rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance of a smartphone application
Time frame: A day before surgery at ward
Based on the data saved in the application, when the program started and ended, how many steps and distance the patient exercised per day, how many sets patient did muscle exercise per day and week will be collected to calculate the compliance.
Satisfaction of a smartphone application
Time frame: A day before surgery at ward
Using the questionnaire that we made to evaluation the satisfaction of a smartphone application.
2 secondary outcomes
Korean-EORTC QLQ C-30
Time frame: 4 weeks before the surgery at clinic, a day before the surgery at ward
6-minute walk test
Time frame: 4 weeks before the surgery at clinic, a day before the surgery at ward
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Susie Yoon, PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Prehabilitation, run by Seoul National University Hospital.
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 4 inclusion and 4 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 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Susie Yoon, PhD (+82-2-2072-1860, susiey87@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance of a smartphone application (time frame: A day before surgery at ward). The study lists 2 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 11 May 2022.