Effect of a Telerehabilitation-exercise Intervention in Oncology Patients in the Covid-19 Pandemic
Online exercise program tested for cancer patients during COVID-19
Plain English Summary
Telerehabilitation in Oncology Patients is a Not Applicable clinical trial sponsored by University of Malaga studying Cancer Metastatic, Cancer, Survivorship. This study tested an online exercise and education program for cancer patients and survivors. It was designed for patients with metastatic breast, gynecological cancer, or breast cancer survivors undergoing treatment. Participants engaged in supervised online exercise sessions and received nutritional education. Alternatives could include in-person physical therapy or standard care without specialized exercise programs. The trial aims to enroll 30 participants.
Official Summary
The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with metastatic breast, gynecological cancer, or breast cancer survivors under treatment can join. You must agree to participate and be reachable by email or messaging. A good internet connection and access to a computer are required. Individuals who are uncomfortable with technology or being at home may not be suitable. This trial is studying Cancer Metastatic, Cancer, Survivorship, so participants generally need a confirmed diagnosis.
What They're Measuring
The study measured how well the online exercise program worked and if patients could stick with it, indicating its practicality for remote cancer care. The specific primary outcome measures are: Suitability of exercise intensity (Through study completion, an average of 3 months); Verification of exercise intensity (Through study completion, an average of 3 months); Total attendance (After intervention, an average of 3 months); Absence type (Through study completion, an average of 3 months); Attendance type (Through study completion, an average of 3 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses the need for accessible cancer rehabilitation during pandemics, offering a way for patients to continue essential exercise and education remotely. This research targets Cancer Metastatic, Cancer, Survivorship, where improved treatment options are needed.
Investor Insight
This trial signals a growing interest in digital health solutions for cancer care, a market that expanded significantly during the pandemic, with potential for remote patient monitoring and therapy.
Is This Trial Right for Me?
Ask your doctor if this type of online program is right for your specific cancer and treatment. Be prepared to commit to 1-hour sessions, twice a week for 12 weeks, with good internet access. You'll need to be comfortable using a computer and potentially have an adult present for initial assessments. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: SINGLE
- Enrollment: 30 participants
Interventions
- 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.
Primary Outcomes
- Suitability of exercise intensity (Through study completion, an average of 3 months)
- Verification of exercise intensity (Through study completion, an average of 3 months)
- Total attendance (After intervention, an average of 3 months)
- Absence type (Through study completion, an average of 3 months)
- Attendance type (Through study completion, an average of 3 months)
Secondary Outcomes
- Change from Cancer-Related Fatigue (CRF) (Prior and after intervention, an average of 3 months)
- Change from Functional capacity (prior and after intervention, an average of 3 months)
- Change from Upper limb functionality (%) (prior and after intervention, an average of 3 months)
- Change from Lower limb functionality (%) (prior and after intervention, an average of 3 months)
- Change from Quality of life (self-reported questionnaire) (prior and after intervention, an average of 3 months)
Full Eligibility Criteria
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).
Trial Locations
- Antonio Cuesta Vargas, Málaga, Spain
Frequently Asked Questions
What is clinical trial NCT04547634?
NCT04547634 is a Not Applicable INTERVENTIONAL study titled "Telerehabilitation in Oncology Patients." It is currently completed and is sponsored by University of Malaga. The trial targets enrollment of 30 participants.
What conditions does NCT04547634 study?
This trial investigates treatments for Cancer Metastatic, Cancer, Survivorship. The primary condition under study is Cancer Metastatic.
What treatments are being tested in NCT04547634?
The interventions being studied include: 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.
What does Not Applicable mean for NCT04547634?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT04547634?
This trial is currently "Completed." It started on 2023-10-01. The estimated completion date is 2024-12-01.
Who is sponsoring NCT04547634?
NCT04547634 is sponsored by University of Malaga. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04547634?
The trial aims to enroll 30 participants. The trial status is completed.
How is NCT04547634 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs single masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT04547634?
The primary outcome measures are: Suitability of exercise intensity (Through study completion, an average of 3 months); Verification of exercise intensity (Through study completion, an average of 3 months); Total attendance (After intervention, an average of 3 months); Absence type (Through study completion, an average of 3 months); Attendance type (Through study completion, an average of 3 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04547634 being conducted?
This trial is being conducted at 1 site, including Málaga (Spain).
Where can I find official information about NCT04547634?
The official record for NCT04547634 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04547634. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04547634 testing in simple terms?
This study tested an online exercise and education program for cancer patients and survivors. It was designed for patients with metastatic breast, gynecological cancer, or breast cancer survivors undergoing treatment.
Why is this trial significant?
This trial addresses the need for accessible cancer rehabilitation during pandemics, offering a way for patients to continue essential exercise and education remotely.
What are the potential risks of participating in NCT04547634?
Potential risks include muscle strain or injury if exercises are not performed correctly, similar to any exercise program. Some participants might experience fatigue or discomfort from the exercises, which should be reported to the program coordinators. Technical issues with internet connection or computer access could disrupt participation. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04547634?
Ask your doctor if this type of online program is right for your specific cancer and treatment. Be prepared to commit to 1-hour sessions, twice a week for 12 weeks, with good internet access. You'll need to be comfortable using a computer and potentially have an adult present for initial assessments. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04547634 signal from an investment perspective?
This trial signals a growing interest in digital health solutions for cancer care, a market that expanded significantly during the pandemic, with potential for remote patient monitoring and therapy. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants engaged in supervised online exercise sessions and received nutritional education. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.