CancerNCT07368192
Community-Based Exercise Oncology: Real-World Evidence of High Adherence, Improved Quality of Life and Cost-Effectiveness Across the Cancer Continuum
An observational study of Cancer and Neoplams, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
This prospective observational cohort study evaluates a community-based supervised exercise oncology program delivered in real-world settings in Madrid, Spain. The program is designed for adults with a cancer diagnosis across the cancer continuum, including survivors, patients undergoing active treatment, individuals… Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 492 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 31 Jul 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Adults (≥18) with a confirmed cancer diagnosis. * At any stage of the disease. * Who have been medically cleared to participate in supervised exercise.
Who may be able to join
- Age ≥18 years.
- Confirmed diagnosis of cancer, at any stage of disease.
- Medical clearance to perform moderate-intensity physical exercise.
- Able to ambulate independently without assistive devices.
- Willingness to attend supervised exercise sessions for a follow-up period of at least 12 months.
Who cannot join
- Absolute medical contraindications to exercise (e.g., unstable angina, uncontrolled arrhythmias, severe anemia, acute infection, or thrombosis).
- Unstable metastatic bone disease without radiologic and/or oncologic clearance.
- Cognitive or functional impairment preventing safe participation in the exercise program.
- Concurrent participation in another structured exercise intervention or clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational cohort study evaluates a community-based supervised exercise oncology program delivered in real-world settings in Madrid, Spain. The program is designed for adults with a cancer diagnosis across the cancer continuum, including survivors, patients undergoing active treatment, individuals receiving hormonotherapy, and patients with metastatic disease.
Participants take part in a structured multimodal exercise program combining aerobic, resistance, and functional training, delivered in supervised group-based sessions either in person or through synchronous online formats. The primary aims of the study are to assess program adherence, health-related quality of life, fatigue, and cost-effectiveness, expressed as quality-adjusted life years (QALYs). Secondary outcomes include cardiorespiratory fitness, muscular strength, functional capacity, physical activity levels, body composition, and psychological well-being.
Assessments are conducted at baseline and every four months over a 12-month follow-up period. This study provides real-world evidence on the feasibility, clinical impact, and economic value of community-based exercise oncology programs across different stages of the cancer trajectory.
Read the detailed description
This study is a prospective observational cohort analysis of adults with a confirmed cancer diagnosis participating in a community-based supervised exercise oncology program in Madrid, Spain. Participants are referred by oncology specialists or self-referred with medical clearance to engage in moderate-intensity physical exercise.
The intervention consists of supervised multimodal exercise sessions lasting approximately 75 minutes, including warm-up, combined aerobic and resistance training, and cool-down periods. Aerobic training is prescribed using heart rate reserve and perceived exertion scales, while resistance training includes free-weight and functional exercises targeting major muscle groups. Sessions are delivered in small groups either face-to-face or via synchronous online platforms, with individualized progression and safety monitoring.
Participants undergo standardized assessments at baseline and at 4, 8, and 12 months. Primary outcomes include adherence to supervised exercise sessions, health-related quality of life, fatigue, and cost-effectiveness measured through quality-adjusted life years derived from EQ-5D instruments. Secondary outcomes include estimated cardiorespiratory fitness, muscular strength, functional capacity tests, physical activity behavior, body composition, and psychological outcomes.
The study aims to generate real-world evidence on the feasibility, effectiveness, and economic impact of integrating structured exercise programs into community-based cancer care across different clinical stages of disease.
- Keywords
- exercise oncology, Community-based program, Real-world evidence, Adherence, Quality of life, QALYs, Cost-effectiveness
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cancer survivors | Adults with a previous cancer diagnosis who had completed primary oncological treatment and were participating in a community-based supervised exercise oncology program. | |
| Active Cancer Treatment | Adults with a cancer diagnosis undergoing active oncological treatment, excluding hormonotherapy, who were participating in the supervised community-based exercise oncology program. | |
| Hormone therapy | Adults with a cancer diagnosis receiving hormonotherapy who were enrolled in the supervised community-based exercise oncology program. | |
| Metastatic | Adults with metastatic cancer participating in the supervised community-based exercise oncology program, with medical clearance for moderate-intensity exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Percentage of supervised exercise sessions completed out of scheduled sessions.
Measured: Baseline, 4 months, 8 months, and 12 months.
Health-related quality of life (FACT-G)
Health-related quality of life (units on a scale) assessed using the Functional Assessment of Cancer Therapy - General (FACT-G)
Measured: Baseline, 4 months, 8 months, and 12 months.
Fatigue (FACT-F)
Fatigue (units on a scale) assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F).
Measured: Baseline, 4 months, 8 months, and 12 months.
Quality-adjusted life years (QALYs)
Quality-adjusted life years calculated by integrating EQ-5D utility scores collected at multiple time points over the 12-month follow-up period. Repeated EQ-5D measurements are aggregated to derive a single QALY value per participant.
Measured: Baseline, 4 months, 8 months, and 12 months.
Barriers to participation
Using a structured questionnaire based on previously published frameworks on determinants of adherence in cancer survivors.
Measured: Baseline, 4 months, 8 months, and 12 months.
Secondary outcomes (12)
Estimated VO₂max
Estimated maximal oxygen uptake (VO₂max) assessed using the Bruce treadmill protocol and Mackenzie equation.
Measured: Baseline, 4 months, 8 months, and 12 months.
Muscular strength
Upper- and lower-limb muscular strength (kg) estimated using submaximal tests to estimate one-repetition maximum (1RM).
Measured: Baseline, 4 months, 8 months, and 12 months.
Functional capacity
Functional capacity assessed using the 6-Minute Walk Test (6MWT) in meters.
Measured: Baseline, 4 months, 8 months, and 12 months.
Functional capacity
Functional capacity assessed using the 30-second Sit-to-Stand test (repetitions)
Measured: Baseline, 4 months, 8 months, and 12 months.
Body weight (kg)
Body weight assessed by bioelectrical impedance analysis using the Tanita MC-601F.
Measured: Baseline, 4 months, 8 months, and 12 months.
Body Fat Percentage (%)
Body Fat Percentage (%) assessed by bioelectrical impedance analysis (Tanita MC-601F).
Measured: Baseline, 4 months, 8 months, and 12 months.
Fat Mass (kg)
Fat Mass (kg) assessed by bioelectrical impedance analysis (Tanita MC-601F).
Measured: Baseline, 4 months, 8 months, and 12 months.
Lean Mass Percentage (%)
Lean Mass Percentage (%) assessed by bioelectrical impedance analysis (Tanita MC-601F).
Measured: Baseline, 4 months, 8 months, and 12 months.
Lean Mass (kg)
Lean Mass (kg) assessed by bioelectrical impedance analysis (Tanita MC-601F).
Measured: Baseline, 4 months, 8 months, and 12 months.
Physical activity
Physical activity levels assessed using the International Physical Activity Questionnaire (IPAQ). The IPAQ estimates total physical activity expressed as metabolic equivalent minutes per week (MET-min/week), calculated from self-reported frequency, duration, and intensity of physical activity. Scores range from 0 MET-min/week to no upper limit, with higher values indicating higher levels of physical activity.
Measured: Baseline, 4 months, 8 months, and 12 months.
Anxiety (HADS-A)
Symptoms of anxiety (units on a scale) assessed using the Hospital Anxiety Scale (HADS-A) The HADS-A consists of 7 items scored from 0 to 3, yielding a total score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Measured: Baseline, 4 months, 8 months, and 12 months.
Depression (HADS-D)
Depressive symptoms assessed using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D). The HADS-D consists of 7 items scored from 0 to 3, yielding a total score ranging from 0 to 21, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline, 4 months, 8 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start10 Jan 2022
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 492 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pontificia Comillas, Ejercicio y Cáncer (Community Exercise Program)
- Responsible party
- Sponsor
- Investigators
- Soraya Casla-Barrio, PhD., Principal investigator, Director of the Exercise and Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368192
- Sponsor's protocol ID
- COHORT-EYC-22-25
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations, as the dataset includes sensitive health information collected in a real-world community-based program. Data are stored in accordance with local data protection regulations and institutional policies.
Publications
Casla-Barrio S, Castellanos-Montealegre M, Pareja-Galeano H. The impact of multimodal high intensity exercise program comparing online and onsite interventions in breast cancer survivors: a randomized controlled trial. Clin Transl Oncol. 2026 Jan;28(1):184-192. doi: 10.1007/s12094-025-03979-x. Epub 2025 Jul 11.
PubMed 40643869
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Exercise Oncology: Real-World Evidence of High Adherence, Improved Quality of Life and Cost-Effectiveness Across the Cancer Continuum
- ClinicalTrials.gov ID
- NCT07368192
- Acronym / sponsor ID
- COHORT-EYC-22-25
- Keywords
- exercise oncology, Community-based program, Real-world evidence, Adherence, Quality of life, QALYs, Cost-effectiveness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 492 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Universidad Pontificia Comillas, Ejercicio y Cáncer (Community Exercise Program)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
This prospective observational cohort study evaluates a community-based supervised exercise oncology program delivered in real-world settings in Madrid, Spain. The program is designed for adults with a cancer diagnosis across the cancer continuum, including survivors, patients undergoing active treatment, individuals receiving hormonotherapy, and patients with metastatic disease.
Participants take part in a structured multimodal exercise program combining aerobic, resistance, and functional training, delivered in supervised group-based sessions either in person or through synchronous online formats. The primary aims of the study are to assess program adherence, health-related quality of life, fatigue, and cost-effectiveness, expressed as quality-adjusted life years (QALYs). Secondary outcomes include cardiorespiratory fitness, muscular strength, functional capacity, physical activity levels, body composition, and psychological well-being.
Assessments are conducted at baseline and every four months over a 12-month follow-up period. This study provides real-world evidence on the feasibility, clinical impact, and economic value of community-based exercise oncology programs across different stages of the cancer trajectory.
Detailed description
This study is a prospective observational cohort analysis of adults with a confirmed cancer diagnosis participating in a community-based supervised exercise oncology program in Madrid, Spain. Participants are referred by oncology specialists or self-referred with medical clearance to engage in moderate-intensity physical exercise.
The intervention consists of supervised multimodal exercise sessions lasting approximately 75 minutes, including warm-up, combined aerobic and resistance training, and cool-down periods. Aerobic training is prescribed using heart rate reserve and perceived exertion scales, while resistance training includes free-weight and functional exercises targeting major muscle groups. Sessions are delivered in small groups either face-to-face or via synchronous online platforms, with individualized progression and safety monitoring.
Participants undergo standardized assessments at baseline and at 4, 8, and 12 months. Primary outcomes include adherence to supervised exercise sessions, health-related quality of life, fatigue, and cost-effectiveness measured through quality-adjusted life years derived from EQ-5D instruments. Secondary outcomes include estimated cardiorespiratory fitness, muscular strength, functional capacity tests, physical activity behavior, body composition, and psychological outcomes.
The study aims to generate real-world evidence on the feasibility, effectiveness, and economic impact of integrating structured exercise programs into community-based cancer care across different clinical stages of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cancer survivors | – | –Adults with a previous cancer diagnosis who had completed primary oncological treatment and were participating in a community-based supervised exercise oncology program. |
| Active Cancer Treatment | – | –Adults with a cancer diagnosis undergoing active oncological treatment, excluding hormonotherapy, who were participating in the supervised community-based exercise oncology program. |
| Hormone therapy | – | –Adults with a cancer diagnosis receiving hormonotherapy who were enrolled in the supervised community-based exercise oncology program. |
| Metastatic | – | –Adults with metastatic cancer participating in the supervised community-based exercise oncology program, with medical clearance for moderate-intensity exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Adults (≥18) with a confirmed cancer diagnosis. * At any stage of the disease. * Who have been medically cleared to participate in supervised exercise.
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Confirmed diagnosis of cancer, at any stage of disease.
- Medical clearance to perform moderate-intensity physical exercise.
- Able to ambulate independently without assistive devices.
- Willingness to attend supervised exercise sessions for a follow-up period of at least 12 months.
Key exclusion criteria (4 listed)
- Absolute medical contraindications to exercise (e.g., unstable angina, uncontrolled arrhythmias, severe anemia, acute infection, or thrombosis).
- Unstable metastatic bone disease without radiologic and/or oncologic clearance.
- Cognitive or functional impairment preventing safe participation in the exercise program.
- Concurrent participation in another structured exercise intervention or clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherence
Time frame: Baseline, 4 months, 8 months, and 12 months.
Percentage of supervised exercise sessions completed out of scheduled sessions.
Health-related quality of life (FACT-G)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Health-related quality of life (units on a scale) assessed using the Functional Assessment of Cancer Therapy - General (FACT-G)
Fatigue (FACT-F)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Fatigue (units on a scale) assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F).
Quality-adjusted life years (QALYs)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Quality-adjusted life years calculated by integrating EQ-5D utility scores collected at multiple time points over the 12-month follow-up period. Repeated EQ-5D measurements are aggregated to derive a single QALY value per participant.
Barriers to participation
Time frame: Baseline, 4 months, 8 months, and 12 months.
Using a structured questionnaire based on previously published frameworks on determinants of adherence in cancer survivors.
12 secondary outcomes
Estimated VO₂max
Time frame: Baseline, 4 months, 8 months, and 12 months.
Muscular strength
Time frame: Baseline, 4 months, 8 months, and 12 months.
Functional capacity
Time frame: Baseline, 4 months, 8 months, and 12 months.
Functional capacity
Time frame: Baseline, 4 months, 8 months, and 12 months.
Body weight (kg)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Body Fat Percentage (%)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Fat Mass (kg)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Lean Mass Percentage (%)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Lean Mass (kg)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Physical activity
Time frame: Baseline, 4 months, 8 months, and 12 months.
Anxiety (HADS-A)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Depression (HADS-D)
Time frame: Baseline, 4 months, 8 months, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Results publication: PubMed 40643869Casla-Barrio S, Castellanos-Montealegre M, Pareja-Galeano H. The impact of multimodal high intensity exercise program comparing online and onsite interventions in breast cancer survivors: a randomized controlled trial. Clin Transl Oncol. 2026 Jan;28(1):184-192. doi: 10.1007/s12094-025-03979-x. Epub 2025 Jul 11.
- Official website of the community-based exercise oncology program where the supervised multimodal exercise intervention described in this study is delivered, including general information about the program structure and services.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations, as the dataset includes sensitive health information collected in a real-world community-based program. Data are stored in accordance with local data protection regulations and institutional policies.
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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.
Soraya Casla-Barrio, PhD. principal investigator
Director of the Exercise and Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Neoplams, run by University of Castilla-La Mancha 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 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 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?
This study is still under way. Results are not available in the source record yet.
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?
Adherence (time frame: Baseline, 4 months, 8 months, and 12 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?
On the ClinicalTrials.gov record for NCT07368192, which also lists 1 linked publication.
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 26 Jan 2026.