Onco Move - Improvement of Psychophysical Fitness in Adult Cancer Survivors

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGdansk University of Physical Education and Sport

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Onco Move multicomponent face-to-face training program

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

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.

Time frame
From enrolment to 3 months after the intervention

Secondary outcomes

1

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

The FSFI is a 19-item validated questionnaire measuring female sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. Scores range from 2 to 36, with higher scores indicating better sexual function. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Time frame
From enrolment to 3 months after the intervention
2

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

The IIEF is a 15-item questionnaire assessing male sexual function, including erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Scores range from 5 to 75, with higher scores indicating better sexual function. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Time frame
From enrolment to 3 months after the intervention
3

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

UMACL measures three mood dimensions: tense arousal, energetic arousal, and hedonic tone. Scores vary by subscale; higher scores indicate greater presence of the respective mood state. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Time frame
From enrolment to 3 months after the intervention
4

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

KPS assesses perceived psychosocial stress across domains such as work and emotional strain. Scores vary by domain; higher scores indicate greater perceived stress. Data collected via digital or paper formats will be analyzed using repeated measures ANOVA and linear mixed-effects models to assess changes over time. Missing data will be addressed with multiple imputation.

Time frame
From enrolment to 3 months after the intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: