Community-Based Exercise Oncology: Real-World Evidence of High Adherence, Improved Quality of Life and Cost-Effectiveness Across the Cancer Continuum

January 20, 2026 updated by: University of Castilla-La Mancha

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
492

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28007
        • Ejercicio y Cáncer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Percentage of supervised exercise sessions completed out of scheduled sessions.
Baseline, 4 months, 8 months, and 12 months.
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)
Baseline, 4 months, 8 months, and 12 months.
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).
Baseline, 4 months, 8 months, and 12 months.
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.
Baseline, 4 months, 8 months, and 12 months.
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.
Baseline, 4 months, 8 months, and 12 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimated VO₂max
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Estimated maximal oxygen uptake (VO₂max) assessed using the Bruce treadmill protocol and Mackenzie equation.
Baseline, 4 months, 8 months, and 12 months.
Muscular strength
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Upper- and lower-limb muscular strength (kg) estimated using submaximal tests to estimate one-repetition maximum (1RM).
Baseline, 4 months, 8 months, and 12 months.
Functional capacity
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Functional capacity assessed using the 6-Minute Walk Test (6MWT) in meters.
Baseline, 4 months, 8 months, and 12 months.
Functional capacity
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Functional capacity assessed using the 30-second Sit-to-Stand test (repetitions)
Baseline, 4 months, 8 months, and 12 months.
Body weight (kg)
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Body weight assessed by bioelectrical impedance analysis using the Tanita MC-601F.
Baseline, 4 months, 8 months, and 12 months.
Body Fat Percentage (%)
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Body Fat Percentage (%) assessed by bioelectrical impedance analysis (Tanita MC-601F).
Baseline, 4 months, 8 months, and 12 months.
Fat Mass (kg)
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Fat Mass (kg) assessed by bioelectrical impedance analysis (Tanita MC-601F).
Baseline, 4 months, 8 months, and 12 months.
Lean Mass Percentage (%)
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Lean Mass Percentage (%) assessed by bioelectrical impedance analysis (Tanita MC-601F).
Baseline, 4 months, 8 months, and 12 months.
Lean Mass (kg)
Time Frame: Baseline, 4 months, 8 months, and 12 months.
Lean Mass (kg) assessed by bioelectrical impedance analysis (Tanita MC-601F).
Baseline, 4 months, 8 months, and 12 months.
Physical activity
Time Frame: Baseline, 4 months, 8 months, and 12 months.
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.
Baseline, 4 months, 8 months, and 12 months.
Anxiety (HADS-A)
Time Frame: Baseline, 4 months, 8 months, and 12 months.
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.
Baseline, 4 months, 8 months, and 12 months.
Depression (HADS-D)
Time Frame: Baseline, 4 months, 8 months, and 12 months.
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.
Baseline, 4 months, 8 months, and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Castilla-La Mancha

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Pontificia Comillas
Ejercicio y Cáncer (Community Exercise Program)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Soraya Casla-Barrio, PhD., Director of the Exercise and Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COHORT-EYC-22-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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