Telerehabilitation in Oncology Patients

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547634
• Other study ID #: Teleclub_cam
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: University of Malaga
• Contact: Antonio I Vargas, PhD, PT
• Phone: 0034951952852
• Email: acuesta[@]uma.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Cancer Metastatic
• Neoplasms
• Survivorship

Intervention

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.

Locations

Country	Name	City	State
Spain	Antonio Cuesta Vargas	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suitability of exercise intensity	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
Primary	Verification of exercise intensity	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
Primary	Total attendance	Total of days of attendance	After intervention, an average of 3 months
Primary	Absence type	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
Primary	Attendance type	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	Change from Cancer-Related Fatigue (CRF)	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
Secondary	Change from Functional capacity	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
Secondary	Change from Upper limb functionality (%)	the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled online	prior and after intervention, an average of 3 months
Secondary	Change from Lower limb functionality (%)	the Spanish version of Lower Limb Functional Index (LLFI) questionnaire will be filled online	prior and after intervention, an average of 3 months
Secondary	Change from Quality of life (self-reported questionnaire)	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
Secondary	Change from specific Breast Cancer Quality of life (self-reported questionnaire)	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