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

NCT07368192 | Active Not Recruiting

• 1 other identifier: COHORT-EYC-22-25
• Study Type: observational
• Target: 492
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cancer; Neoplams

Keywords

exercise oncology; Community-based program; Real-world evidence; Adherence; Quality of life; QALYs; Cost-effectiveness

Outcome Measures

Primary Outcomes (5)

• Adherence

  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)

  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)

  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)

  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

  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 Outcomes (12)

• Estimated VO₂max

  Baseline, 4 months, 8 months, and 12 months.

• Muscular strength

  Baseline, 4 months, 8 months, and 12 months.

• Functional capacity

  Baseline, 4 months, 8 months, and 12 months.

• Functional capacity

  Baseline, 4 months, 8 months, and 12 months.

• Body weight (kg)

  Baseline, 4 months, 8 months, and 12 months.

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Universidad Pontificia Comillas: collaborator
• Ejercicio y Cáncer (Community Exercise Program): collaborator

Study Sites (1)

Ejercicio y Cáncer Center

Madrid, Madrid, 28007, Spain

Location

Related Publications (1)

• 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.

  PMID: 40643869 RESULT

Related Links

• 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.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Soraya Casla-Barrio, PhD.

  Director of the Exercise and Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 26, 2026
• Study Start: January 10, 2022
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)