Telerehabilitation in Oncology Patients

November 30, 2023 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

Effect of a Telerehabilitation-exercise Intervention in Oncology Patients in the Covid-19 Pandemic

The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Current literature shows that Therapeutic Exercise has multiple benefits in oncology patients, such as improvements in function and quality of life, and ameliorates symptoms such as cancer-related fatigue. Furthermore, given the risk of obesity, both exercise and diet play a key role in recovery from cancer. In fact, current guidelines support the use of exercise with therapeutic purposes as a complement to cancer treatment.

As a consequence of the COVID-19 pandemic, oncology patients present more difficulties to attend programs, as the vast majority are immunosuppressed, and they are considered risk population. Therefore, new online (TEEP) must be developed to facilitate the benefits of these programs in the post-COVID Era. This study analyses the feasibility (in terms of suitability and verification of exercise prescription, absence and attendance type, and total days of attendance) and the effect (in weight, physical function, and symptoms) in cancer patients and survivors.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Antonio I Vargas, PhD, PT
  • Phone Number: 0034951952852
  • Email: acuesta@uma.es

Study Contact Backup

Study Locations

  • Spain
      • Málaga, Spain
        • Recruiting
        • Antonio Cuesta Vargas
        • Contact:
          • Antonio Cuesta Vargas, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Metastatic breast patient, gynecological cancer patient, or breast cancer survivor under adjuvant treatment after surgical intervention.
  • Having given informed consent to participate voluntarily in the program and to be in contact via telematics (email or messaging platform).
  • Have a good internet connection
  • Be accompanied by an adult on the day of assessment.
  • Availability to access the computer on during the intervention.

Exclusion Criteria:

  • Technophobia
  • Domatophobia or self-report of adversity to be at home.
  • Lack of logistical requirements (Internet and lack of skill in its use).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
The sample will receive of a Therapeutic Exercise and Education programme
Other: Therapeutic Exercise and Education
The intervention will consist of 30 minutes of strength exercises followed by 20 minutes of endurance with aerobic training, individualized based on the evaluations of muscular strength and endurance. Sessions lasted 1 hour, carried out twice a week, for 12 weeks. This intervention will be complemented by nutritional education.
No Intervention: Control
Subjects will be told to continue with their normal activity of daily living. After the intervention in the experimental group, the control group will be offered intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suitability of exercise intensity
Time Frame: Through study completion, an average of 3 months
Patients are asked before each session to mark in a numerical scale how are they feeling that day to push themselves and get their session well done. From 0 (very well) to 10 (very badly). Higher scores mean a worse feeling.
Through study completion, an average of 3 months
Verification of exercise intensity
Time Frame: Through study completion, an average of 3 months
Patients are asked to score the feeling of perceived effort after the session with the Borg Perceived Exertion scale (6-20). Higher scores mean a worse perceived exertion.
Through study completion, an average of 3 months
Total attendance
Time Frame: After intervention, an average of 3 months
Total of days of attendance
After intervention, an average of 3 months
Absence type
Time Frame: Through study completion, an average of 3 months
Reasons of absence, categorized as: personal matter, visit the oncology, medical appointment (no related to oncology treatment), health problem, connection problem or unknown.
Through study completion, an average of 3 months
Attendance type
Time Frame: Through study completion, an average of 3 months
Attendance type, categorized as: full attendance, partly attendance because of lack of time, partly attendance because of internet connection problem
Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Cancer-Related Fatigue (CRF)
Time Frame: Prior and after intervention, an average of 3 months
The Spanish version of the Piper Fatigue Scale-Revised (PFS-R) will be used. Its total score is the sum of all items (from 0 to 220), with higher values indicate a higher level of fatigue (worse outcome)
Prior and after intervention, an average of 3 months
Change from Functional capacity
Time Frame: prior and after intervention, an average of 3 months
It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.
prior and after intervention, an average of 3 months
Change from Upper limb functionality (%)
Time Frame: prior and after intervention, an average of 3 months
the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled online
prior and after intervention, an average of 3 months
Change from Lower limb functionality (%)
Time Frame: prior and after intervention, an average of 3 months
the Spanish version of Lower Limb Functional Index (LLFI) questionnaire will be filled online
prior and after intervention, an average of 3 months
Change from Quality of life (self-reported questionnaire)
Time Frame: prior and after intervention, an average of 3 months
It will be assessed by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) version 3.0. EORTC QLQ-C30 comprises 30 items and contains five functional scales, three symptom scales, a global health status/QoL scale, and six single items. Raw scores can be linearly converted to a 0-100 scale with higher scores reflecting higher levels of function (better outcome) and higher levels of symptom show bigger problems (worse outcome).
prior and after intervention, an average of 3 months
Change from specific Breast Cancer Quality of life (self-reported questionnaire)
Time Frame: prior and after intervention, an average of 3 months
It will be assessed by The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life questionnaire (EORTC QLQ-BR23). This is a breast cancer module of EORTC QLQ-C30 which contains 23 items that assess disease symptom, side effects of treatment, body image, sexual functioning, and future perspective. All items are rated on a 4-point scale (from 1- not at all, to very much). Higher scores represent better functioning (better outcome), and higher scores of symptom show bigger issues (worse outcome)
prior and after intervention, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 17, 2020

First Submitted That Met QC Criteria

September 7, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Teleclub_cam

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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