Behaviors and Mental Disorders

All Conditions

Quality of Life

The exercise program consisted of a 12-week supervised intervention, with twice per week sessions of 90 minutes, and was developed in a friendly and close environment, which promoted social interaction between participants. Apart from the twice-weekly supervised sessions, as early as the fifth week, one or two individualized home-based sessions were established for each patient in order to achieve his/her specific objectives with the help of any required supporting material such as documents and video references with exercise examples.

All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR)

12-week supervised intervention, 90 minutes sessions twice per week All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR).

Fitness work in the first eight sessions was planned following 30 min of time on cardiovascular exercise 55 min on work out in low to moderate intensity. In the next eight sessions, the time spent on cardiovascular work was slightly increased to 35 min, with 50 min focused on work out, combining moderate to high-intensity sessions. The last eight sessions presented the same structure as the first ones but combining moderate to high intensity.

Physical exercise intervention

Soraya Casla Barrio, Phd

Exercise-oncology is an emerging area, but exist a lack of information about an effective methodology to establish counseling programs long-lasting and not based on research objectives. This observational study objective was to evaluate the feasibility and effective exercise-oncology community intervention in a real patients sample.

The application of exercise-oncology in a real stage is a growing field, having a crucial role throughout the illness. In this sense, exercise has been proved as an effective intervention to prevent reductions in fitness and functional capacity, muscle mass and strength loss; and risings of fat mass, fatigue, anxiety and quality of sleep \[1, 2\]. Moreover, there has been increasing evidence proving the positive effects of exercise training on some prognostic biomarkers related to cancer such as reductions in sex hormone levels, \[3, 4\] insulin levels, \[5\] inflammation levels \[6-9\] and rising the immune function \[10\]. The balance of these biomarkers has been directly linked to an improvement in survival in active patients of breast, colon and prostate cancer.

Despite all these benefits, patients and clinical specialists present a reduced adherence to clinical or community exercise-oncology programs, specially when patients are under oncology treatments. In order to provide support, the multidisciplinary roundtable organised by the American College of Sport Medicine (ACSM) published their professional guidelines in 2010 and reviewed in 2018, describing not only the exercise benefits but also the exercise interventions effectiveness \[11, 12\]. In addition, other institutions, such as the American Cancer Society (ACSM) or the Canadian Society for Exercise Physiology (CSEP), have highlighted the same idea, publishing general recommendations for cancer patients and cancer survivors to support clinicians and promote exercise adherence \[13, 14\].

However, in Spain, there is still a tremendous lack of these kind of programs. This is really surprising, even more if one considers the statement of the Sociedad Española de Oncología Médica (SEOM) which enlightened the necessity to develop effective community exercise-oncology interventions to support oncologists and patients by ensuring the performance of exercise in safeness conditions as well as a long-lasting adherence to physical exercise \[15\].

For this reason, the main objective of this pilot experience was to propose a feasible model for the implementation of an exercise-oncology program into specific community programs, providing specific support to clinicians. An effective exercise dose-response, to reduce side effects, as well as the safeness and exercise adherence after the program in cancer patients in different stages, were also evaluated.

How to Carry on an Effective Community Program of Exercice-oncology.

How to Carry on an Effective Community Program of Exercice-oncology. A Pilot Experience

to propose a feasible model for the implementation of an exercise-oncology program into specific community programs, providing specific support to clinicians.

To evaluate an effective exercise dose-response to reduce side effects, as well as the safeness and exercise adherence after the program

Asociación Española contra el Cáncer

Exercise physiologist

Neoplasms

Head and Neck Neoplasms

The experimental intervention consist of a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.

Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT. The PEI consists of a 60 minutes intervention twice a week and will be supervised by a physiotherapist specialized in oncology.

Patients who receive the intervention also have to do home-based aerobic and muscle strength exercises by themselves three times a week.

Experimental Intervention

Caroline Speksnijder, Dr.

Jorine Vermaire, Dr.

Yvette Kriellaars, Msc.

The goal of this trial within cohorts study is to determine and compare physical performance, muscle strength, fatigue, quality of life, body composition, nutritional status, physical activity, treatment tolerability of radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT), and healthcare related costs in patients with head and neck cancer (HNC) with and without a 10 week physical exercise intervention (PEI) during RT, CRT or BRT ((C/B)RT).

Patients who were randomized in the PEI group and accepted the invitation to undergo the experimental intervention receive a PEI twice a week for 10 weeks. The PEI will be executed 6 to 7 weeks during and 3 to 4 weeks after (C/B)RT.

Researchers will compare patients who undergo the PEI with patients who did not undergo the PEI to see if there is difference in physical performance, muscle strength, fatigue, Quality of Life, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT , and healthcare related costs in patients with Head and Neck Cancer (HNC) with and without a 10 week Physical Exercise Intervention (PEI) during (C/B)RT).

In this study a TwiCs design will be used. The TwiCs design consists of an experimental intervention study within an observational longitudinal cohort. This design uses a staged-informed consent. Patients will be asked to participate in an observational longitudinal cohort study and will be informed about the design with the probability to be randomly invited for an experimental intervention which they can accept or refuse. When patients are willing to participate in the observational longitudinal cohort, an informed consent (IC) will be signed. Directly after cohort enrollment, all patients will be randomized.

Physical Exercise for Patients With Head and Neck Cancer

The Effect of Physical Exercise During Radiotherapy on Physical Functioning in Patients With Head and Neck Cancer: a Trial Within Cohorts, the VITAL Study

Assessed by the EuroQol- five dimensions- five level (EQ-5D-5L). This questionnaire contains 6 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression and a total score for global health. The first 5 item have 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The score of these item can range from 0 to 4. The higher the total score of these five items, the lower the quality of live. The global health scores on a range 0-100. The higher the score of this item, the higher the global health.

Assessed by the European organisation for research and treatment for cancer quality of life questionnaire (EORTC QLQ-C30). This questionnaire contains 30 questions scoring 9 subscales and 6 single items: 5 functional scales, 3 symptom scales and 1 global health / quality of life scale. The score of each subscale of single items ranges from 0 to 100. A higher score on the functional scales means a high level of functioning. A higher score on the symptom scales means a high level of experiencing symptoms. A higher score on global health / quality of life means a high score of quality of life.

Assessed by the European organisation for research and treatment for cancer quality of life questionnaire head and neck module (EORTC-QLQ-H\&N43). This questionnaire contains 43 specific head and neck cancer questions scoring 19 subscales of symptoms. The higher the score of the subscale, the higher the level symptomology.

Assessed by the multidimensional fatigue inventory (MFI). The MFI contains 20 items scoring the following domains: general, physical and mental fatigue, and reduced activity and motivation. Every scale scores 4 till 20. The greater the score, the more fatigue or limitations in live because of fatigue.

Assessed by the short nutritional assessment questionnaire (SNAQ). The short nutritional assessment questionnaire (SNAQ) consists of three questions and will be used to monitor nutritional status and assess the risk of malnutrition. The total score of this questionnaire ranges from 0 to 7. 0 means no nutritional problems and a high score means malnutrition.

Assessed by the short questionnaire to assess health enhancing physical activity (SQUASH). The SQUASH measures the frequency, duration and intensity of 4 different physical activity: physical activity going to work, physical activity during household activity, physical activity at work, physical activity in spare time. The higher the score, the higher the level of physical activity.

tolerability will be retrieved from medical records and registered as the percentage of scheduled treatment completion, percentage of (C/B)RT adjustment and type of (C/B)RT adjustment.

age, gender, education, employment, marital status tumour site, disease stage, comorbidity, HPV status, tobacco and alcohol use, nutrition status and type of treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
How to Carry on an Effective Community Program of Exercice-oncology.	NCT05078216	Cancer Patients...	Physical exerci...	18 Years -	Asociación Española contra el Cáncer
Physical Exercise for Patients With Head and Neck Cancer	NCT05988060	Head and Neck C...	Experimental In...	18 Years -	Institute Verbeeten
How to Carry on an Effective Community Program of Exercice-oncology.	NCT05078216	Cancer Patients...	Physical exerci...	18 Years -	Asociación Española contra el Cáncer

Spots Global Cancer Trial Database for physical exercise intervention