Onco Move - Improvement of Psychophysical Fitness in Adult Cancer Survivors

NCT07087652 | Not Yet Recruiting

• 1 other identifier: AWFiS/2025_1_MW-P
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The Onco Move project aims to assess the impact of a 16-week supervised multicomponent group exercise training program on the psychophysical well-being of individuals undergoing or recovering from cancer treatment. A total of 70 participants, aged 18-55, with various types of cancer, will be recruited for the study. Participants will be randomly assigned to either an experimental group (which will engage in the Onco Move exercise program) or a control group (usual care). Baseline measurements will be taken to assess their psychological, physiological, functional, and biochemical health. These tests will help determine the initial psychophysical health levels and the quality of life of the participants.The experimental group will undergo group exercise sessions three times a week at the Gdansk University of Physical Education and Sport, led by certified fitness instructors. The study will assess the effects of the program at three different time points: after 8 weeks, after 16 weeks, and 3 months after the completion of the program. The main objective is to investigate how regular Onco Move training influences the physical and psychological health of cancer patients, including their overall functional status, fitness, and quality of life.The findings will provide valuable insights into the positive psychophysical effects of group exercise training for cancer patients and contribute to developing a set of recommended physical activity and exercise forms for oncology patients during and after treatment. Additionally, the results will help in the creation of guidelines for recommending psychophysical exercises that could aid recovery and improve the quality of life for cancer patients.

Conditions

Cancer

Keywords

cancer exercise; oncology exercise; physical activity and cancer

Outcome Measures

Primary Outcomes (1)

• Assessed changes from baseline Health-Related Quality of Life (HRQOL)

  HRQOL will be assessed pre-, post-intervention, and at follow-up using validated questionnaire: European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire-Core 30 (EORTC QLQ-C30). This instrument measures general quality of life and includes multiple subscales (e.g. physical, emotional, cognitive functioning). Scores on each scale range from 0 to 100. * For functional scales and global health status, higher scores indicate better functioning or QoL. * For symptom scales/items, higher scores indicate more severe symptoms (i.e. worse outcomes). Data will be collected via digital or paper formats and analyzed. Statistical methods include repeated measures ANOVA and linear mixed-effects models to detect changes over time. Missing data will be handled via multiple imputation. This approach provides a comprehensive assessment of psychological and functional well-being related to the intervention.

  From enrolment to 3 months after the intervention

Secondary Outcomes (48)

• Change in female sexual function, assessed by Female Sexual Function Index (FSFI)

  From enrolment to 3 months after the intervention

• Change in male sexual function, assessed by International Index of Erectile Function (IIEF)

  From enrolment to 3 months after the intervention

• Change in mood states, assessed by UWIST Mood Adjective Checklist (UMACL)

  From enrolment to 3 months after the intervention

• Change in perceived stress, assessed by The Feeling of Stress Questionnaire (KPS)

  From enrolment to 3 months after the intervention

• Change in anxiety and depression symptoms, assessed by the Four-Item Patient Health Questionnaire For Anxiety And Depression (PHQ-4)

  From enrolment to 3 months after the intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Onco Move multicomponent face-to-face training program

Control Group

NO INTERVENTION

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.

Interventions

Onco Move multicomponent face-to-face training program OTHER

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 18 to 55.
• 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.

You may not qualify if:

• Age below 18 or above 55 at the time of registration for the project.
• 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.

Sponsors & Collaborators

• Gdansk University of Physical Education and Sport: lead
• University of Cadiz: collaborator

Study Sites (1)

Gdansk University of Physical Education and Sport

Gdansk, 80-336, Poland

Location

Related Publications (11)

• 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.

  PMID: 38158226 BACKGROUND

• 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.

  PMID: 38739198 BACKGROUND

• 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.

  PMID: 40336008 BACKGROUND

• 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.

  PMID: 40450658 BACKGROUND

• 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.

  PMID: 33739853 BACKGROUND

• 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.

  PMID: 28261579 BACKGROUND

• 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.

  PMID: 32476203 BACKGROUND

• 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.

  PMID: 23296635 BACKGROUND

• 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.

  PMID: 38572751 BACKGROUND

• 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.

  PMID: 32940362 BACKGROUND

• 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.

  PMID: 31626055 BACKGROUND

Related Links

• Recruitment website

MeSH Terms

Conditions

Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David Jiménez-Pavón, Professor

  Universidad de Cadiz

  STUDY DIRECTOR

Central Study Contacts

Marzena Wieczorek-Przybyło, M.Litt.

CONTACT

+48507337078; marzena.wieczorek-przybylo@awf.gda.pl

David Jiménez-Pavón, Professor

CONTACT

+34667788602; david.jimenez@uca.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-04

Locations

PL (1)