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Completed

NCT Number: NCT04547634

Telerehabilitation in Oncology Patients

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

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Key information

Conditions

Cancer Metastatic COVID-19 Cancer Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Neoplasm Metastasis Neoplasms Neoplastic Processes Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Survivorship Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonio Cuesta Vargas

Málaga, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Therapeutic Exercise and Education

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Total attendance

    Time frame: After intervention, an average of 3 months

    Total of days of attendance

  4. 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.

  5. 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

Secondary outcomes

  1. 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)

  2. 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.

  3. 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

  4. 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

  5. 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).

  6. 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)

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 14, 2020
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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