Cancer MetastaticNCT04547634
Telerehabilitation in Oncology Patients
A study testing Therapeutic Exercise and Education in people with Cancer Metastatic and Cancer, run by University of Malaga at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer Metastatic, Cancer, Survivorship
- What is being tested?
- Therapeutic Exercise and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Cancer Metastatic, Cancer, Survivorship
- Being tested
- Therapeutic Exercise and Education
- Keywords
- cancer, oncology, Metastasis, survivors, Exercise Therapy, Therapeutics, Complementary Therapies, covid-19
- Medical subject headings
- Neoplasm Metastasis, Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Exercise and EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The sample will receive of a Therapeutic Exercise and Education programme Receives: Other: Therapeutic Exercise and Education |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 3 months
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.
Measured: Through study completion, an average of 3 months
Total attendance
Total of days of attendance
Measured: After intervention, an average of 3 months
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.
Measured: Through study completion, an average of 3 months
Attendance type
Attendance type, categorized as: full attendance, partly attendance because of lack of time, partly attendance because of internet connection problem
Measured: Through study completion, an average of 3 months
Secondary outcomes (6)
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)
Measured: Prior and after intervention, an average of 3 months
Change from Functional capacity
It will be tested by 30-second Sit-To-Stand Test (30-STS), number of repetitions completed.
Measured: prior and after intervention, an average of 3 months
Change from Upper limb functionality (%)
the Spanish version of Upper Limb Functional Index (ULFI) questionnaire will be filled online
Measured: prior and after intervention, an average of 3 months
Change from Lower limb functionality (%)
the Spanish version of Lower Limb Functional Index (LLFI) questionnaire will be filled online
Measured: prior and after intervention, an average of 3 months
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).
Measured: prior and after intervention, an average of 3 months
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)
Measured: prior and after intervention, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start1 Oct 2023
- Primary completion1 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547634
- Sponsor's protocol ID
- Teleclub_cam
- Status last verified
- Apr 2026
- First submitted
- 17 Aug 2020
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Telerehabilitation-exercise Intervention in Oncology Patients in the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04547634
- Acronym / sponsor ID
- Teleclub_cam
- Conditions
- Cancer Metastatic, Cancer, Survivorship
- Keywords
- cancer, oncology, Metastasis, survivors, Exercise Therapy, Therapeutics, Complementary Therapies, covid-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to analyze the feasibility and effect of an online Therapeutic Exercise and Education programme (TEEP) in cancer patient and survivors
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Therapeutic Exercise and EducationThe sample will receive of a Therapeutic Exercise and Education programme |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Technophobia
- Domatophobia or self-report of adversity to be at home.
- Lack of logistical requirements (Internet and lack of skill in its use).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Exercise and EducationThe 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. | Other | Experimental |
Primary outcome
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.
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.
Total attendance
Time frame: After intervention, an average of 3 months
Total of days of attendance
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.
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
6 secondary outcomes
Change from Cancer-Related Fatigue (CRF)
Time frame: Prior and after intervention, an average of 3 months
Change from Functional capacity
Time frame: 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
Change from Lower limb functionality (%)
Time frame: 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
Change from specific Breast Cancer Quality of life (self-reported questionnaire)
Time frame: prior and after intervention, an average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Exercise and Education in people with Cancer Metastatic and Cancer, run by University of Malaga at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suitability of exercise intensity (time frame: Through study completion, an average of 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.