NCT05363150

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

May 3, 2022

Last Update Submit

May 6, 2022

Conditions

Keywords

Cancer patientCancer SurgeryPrehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    A day before surgery at ward

Secondary Outcomes (2)

  • Korean-EORTC QLQ C-30

    4 weeks before the surgery at clinic, a day before the surgery at ward

  • 6-minute walk test

    4 weeks before the surgery at clinic, a day before the surgery at ward

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who visits preoperative evaluation clinic for preoperative counseling before the cancer surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Susie Yoon, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susie Yoon, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 5, 2022

Study Start

June 1, 2022

Primary Completion

September 1, 2022

Study Completion

December 1, 2022

Last Updated

May 11, 2022

Record last verified: 2022-05