Onco Move - Improvement of Psychophysical Fitness in Adult Cancer Survivors
NCT ID: NCT07087652
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2025-09-01
2026-09-30
Brief Summary
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Detailed Description
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By examining these outcomes, the study aims to provide new insights into how structured physical exercise can benefit cancer patients during and after treatment. This information could serve as the foundation for developing guidelines for recommending specific exercise programs tailored to oncology patients' needs. A total of 70 participants will be recruited for the study. Participants will be carefully selected to include individuals between the ages of 18 and 55 who have undergone or are currently undergoing cancer treatment. They will represent a variety of cancer types to ensure that the findings are applicable across different patient populations. Prior to participation, baseline measurements will be conducted to assess their psychological, physiological, functional, and biochemical health status.After the baseline assessment, participants will be randomly assigned to one of two arm: 1) Experimental group: This group will participate in the Onco Move exercise program, which involves supervised group exercise sessions held three times per week. 2) Control group: Participants in the control group will not engage in the Onco Move program but will continue their usual activities/care and they will get physical activity recommendations. They will receive general wellness advice and physical activity recommendations but will not be prescribed any specific physical exercise training during the study period.
The Onco Move exercise program is specifically designed for cancer patients and will include a combination of aerobic, strength, flexibility, and coordination/balance exercises. The exercise training sessions will be adapted to participants' individual fitness levels and will progress in load/intensity throughout the 16 weeks. The program aims to: (1) Improve aerobic capacity and muscular strength; (2) Enhance flexibility, coordination/balance, and mobility; (3) Reduce fatigue and improve mood; (4) Promote a sense of empowerment and increase overall physical activity levels. Sessions will be held three times a week, with each session lasting approximately 60 minutes (volume parameter). The exercise program will be personalized and tailored to the needs and abilities of each participant, ensuring that they engage in safe and effective exercises that are suitable for their current level of function. All sessions will be supervised by certified fitness instructors who are trained to work with individuals recovering from cancer treatment.
The impact of the Onco Move program will be evaluated at four time points during the study: (1) At the baseline; (2) After 8 weeks of participation in the exercise program; (3) After 16 weeks, at the completion of the exercise program; and (4) Three months after the completion of the program, to assess the longer-term effects of the intervention. At each time point, participants will undergo a comprehensive evaluation, including psychological, physiological, and functional assessments, as well as biochemical testing to measure specific health markers. These time points will help determine the immediate and sustained effects of the fitness program on participants' well-being.The study will use a variety of outcome measures to assess the impact of the Onco Move program. These include: (1) Physical fitness tests: A series of tests designed to assess strength, balance, flexibility, and cardiorespiratory fitness, including the Senior Fitness Test (SFT) and Short Physical Performance Battery (SPPB); (2) Psychological assessments as tools to assess anxiety, depression, stress, and quality of life, such as the Four-Item Patient Health Questionnaire For Anxiety And Depression (PHQ-4) and various scales measuring mood, sexual function, and general health-related quality of life; (3) Biochemical markers, blood samples will be analyzed to measure biomarkers such as IL-6, IL-15, Irisin, BDNF, SPARC, and decorin, which are associated with inflammation, muscle health, and overall physical recovery; (4) Genetic analyses will include polymorphisms located in the following genes: ACE, ACTN3, PPARGC1A, BDNF, VEGF, IL6, NOS3, HIF1A, TNF-α, mTOR pathway, telomeres, and telomerase; (5)Self-Reported Fitness: Participants' subjective assessments of their fitness will be recorded using tools such as the International Fitness Scale (IFIS).
The Onco Move project has the potential to make significant contributions to the field of cancer exercise research. By investigating the psychophysical effects of physical exercise training, the study will provide evidence-based insights into the benefits of structured physical exercise for cancer patients. These findings could lead to the development of guidelines for oncology professionals, helping them to recommend appropriate physical exercise during and after treatment. Furthermore, the study will help shape future exercise programs and improve quality of life for cancer survivors by promoting physical exercise as a central component of post-treatment recovery.The results of this study may also pave the way for health policy changes that encourage the integration of exercise interventions into standard cancer care practices, improving outcomes and empowering cancer survivors to take control of their physical and psychological health. By carefully assessing the effects of the Onco-Move program on various health parameters, the study aims to contribute valuable evidence that will guide the development of personalized and tailored physical exercise interventions for cancer patients. Ultimately, the project seeks to enhance the overall well-being of cancer patients and survivors, improve their quality of life, and provide a foundation for future exercise interventions in oncology care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention Group
The intervention group will participate in a multicomponent face-to-face Onco Move exercise training programme for 16 weeks. The intervention will include three training sessions per week (each lasting 60 minutes), held in the fitness rooms and the gym at Gdansk University of Physical Education and Sport in Poland. The intervention will include aerobic and strength exercises but also coordination/balance and flexibility, with warm-up and cool-down elements. The assessments will be conducted at four points: before the intervention, after 8 weeks, after 16 weeks, and 3 months after the intervention.
Onco Move multicomponent face-to-face training program
The Onco Move intervention will include three training sessions per week (each lasting 60 minutes), held in the fitness rooms and the gym at Gdansk University of Physical Education and Sport in Poland for 16 weeks. The intervention will include aerobic and strength exercises but also coordination/balance and flexibility, with warm-up and cool-down elements.
Control Group
The control group will not participate in the exercise training intervention during the course of the project. However, it will take part in all the assessments just like the experimental group: before the intervention, after 8 weeks, after 16 weeks, and 3 months after the intervention. The control group will be allowed to participate in the training intervention after the Onco Move project has ended.
No interventions assigned to this group
Interventions
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Onco Move multicomponent face-to-face training program
The Onco Move intervention will include three training sessions per week (each lasting 60 minutes), held in the fitness rooms and the gym at Gdansk University of Physical Education and Sport in Poland for 16 weeks. The intervention will include aerobic and strength exercises but also coordination/balance and flexibility, with warm-up and cool-down elements.
Eligibility Criteria
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Inclusion Criteria
* Currently undergoing cancer treatment or up to 5 years post-treatment.
* Individuals with various types of cancer.
* Participants who have been physically inactive and have led a sedentary lifestyle since diagnosis.
* Both genders, with no requirement for equal distribution between women and men.
* Participants who commit to attending three training sessions per week.
* Oncologist's approval for participation in the project.
* Signed informed consent from the patient to participate in the study and consent for personal data processing.
Exclusion Criteria
* Physically active individuals.
* Health conditions preventing continued participation in the study or intervention.
* Participants who do not commit to attending three training sessions per week.
* Lack of oncologist's approval for participation in the study and training activities outlined in the project.
* Lack of signed informed consent for participation in the study and consent for personal data processing.
* Pregnant women\*.
* Pregnant women who wish to participate in the project will be allowed to attend a free lecture on the guidelines from the World Health Organization and the American College of Sports Medicine regarding recommended physical activity for cancer patients.
18 Years
55 Years
ALL
No
Sponsors
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University of Cadiz
OTHER
Gdansk University of Physical Education and Sport
OTHER
Responsible Party
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Principal Investigators
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David Jiménez-Pavón, Professor
Role: STUDY_DIRECTOR
Universidad de Cadiz
Locations
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Gdansk University of Physical Education and Sport
Gdansk, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Cufer T, Kosty MP; Curriculum Development Subgroup-ESMO/ASCO Global Curriculum Working Group. ESMO/ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2023. ESMO Open. 2023 Dec;8(6):101631. doi: 10.1016/j.esmoop.2023.101631. Epub 2023 Oct 23.
Vasilopoulou M, Asimakopoulou Z, Velissari J, Vicha A, Rizogianni M, Pusa S, Stoven S, Ficarra S, Bianco Alpha, Jimenez-Pavon D, Ponce Gonzalez Jesus G, Tavares Paula C, Gomes B, Bayer D, Silva S, Nogueira C, Papakonstantinou S, Musa K, Glorioso F, Vantarakis A. Interventions about physical activity and diet and their impact on adolescent and young adult cancer survivors: a Prisma systematic review. Support Care Cancer. 2024 May 13;32(6):342. doi: 10.1007/s00520-024-08516-0.
Ortega-Gomez S, Di Bartolo L, Velissari J, Gomes B, Pusa S, Thaller J, Papakonstantinou S, Kirkar M, Iannitto E, Moura N, Nogueira C, Ponce-Gonzalez JG, Baxter R, Tavares P, Vantarakis A, Bianco A, Carbonell-Baeza A, Jimenez-Pavon D; OACCUs consortium. Exploring the health benefits of outdoor exercise for cancer survivors: a systematic review of more than 700 individuals. Syst Rev. 2025 May 7;14(1):101. doi: 10.1186/s13643-025-02834-y.
Courneya KS, Vardy JL, O'Callaghan CJ, Gill S, Friedenreich CM, Wong RKS, Dhillon HM, Coyle V, Chua NS, Jonker DJ, Beale PJ, Haider K, Tang PA, Bonaventura T, Wong R, Lim HJ, Burge ME, Hubay S, Sanatani M, Campbell KL, Arthuso FZ, Turner J, Meyer RM, Brundage M, O'Brien P, Tu D, Booth CM; CHALLENGE Investigators. Structured Exercise after Adjuvant Chemotherapy for Colon Cancer. N Engl J Med. 2025 Jul 3;393(1):13-25. doi: 10.1056/NEJMoa2502760. Epub 2025 Jun 1.
Ng AH, Ngo-Huang A, Vidal M, Reyes-Garcia A, Liu DD, Williams JL, Fu JB, Yadav R, Bruera E. Exercise Barriers and Adherence to Recommendations in Patients With Cancer. JCO Oncol Pract. 2021 Jul;17(7):e972-e981. doi: 10.1200/OP.20.00625. Epub 2021 Mar 19.
Gunnell AS, Joyce S, Tomlin S, Taaffe DR, Cormie P, Newton RU, Joseph D, Spry N, Einarsdottir K, Galvao DA. Physical Activity and Survival among Long-term Cancer Survivor and Non-Cancer Cohorts. Front Public Health. 2017 Feb 14;5:19. doi: 10.3389/fpubh.2017.00019. eCollection 2017.
Felser S, Behrens M, Lampe H, Henze L, Grosse-Thie C, Murua Escobar H, Rohde K, Albrecht I, Zschorlich V, Junghanss C. Motivation and preferences of cancer patients to perform physical training. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13246. doi: 10.1111/ecc.13246. Epub 2020 May 31.
Blaney JM, Lowe-Strong A, Rankin-Watt J, Campbell A, Gracey JH. Cancer survivors' exercise barriers, facilitators and preferences in the context of fatigue, quality of life and physical activity participation: a questionnaire-survey. Psychooncology. 2013 Jan;22(1):186-94. doi: 10.1002/pon.2072. Epub 2011 Oct 6.
Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
Miller KD, Fidler-Benaoudia M, Keegan TH, Hipp HS, Jemal A, Siegel RL. Cancer statistics for adolescents and young adults, 2020. CA Cancer J Clin. 2020 Nov;70(6):443-459. doi: 10.3322/caac.21637. Epub 2020 Sep 17.
Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
Related Links
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Recruitment website
Other Identifiers
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AWFiS/2025_1_MW-P
Identifier Type: -
Identifier Source: org_study_id
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