Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Analgesics

All Drugs and Chemicals

Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises.

Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment

Patients have 3-monthly geriatric follow-up with biological tests, anti-aromatase agents blood dosing and a clinical assessment (M3 to M9, M15 to M22 and M27 to M33). Musculoskeletal adverse events and quality of life level will be reported and analgesic treatment adapted. Patients will be proposed weekly Taï-Chi exercises to improve joint flexibility, muscular tonus and balance and reduce fall risk.

A broader geriatric assessment including functionality, gait analysis and nutrition will be performed each year (M12, M24 and M36).

Arm A: adapted physical activity + enhanced geriatric follow-up

No intervention

Claire Falandry, MD-PhD

PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.

Patients in the intervention group will be proposed:

* A regular geriatric follow up including an attentive screening of joint symptoms and functionality,
* An adapted treatment of join pain,
* Weekly sessions of adapted physical activity (Taï Chi),
* And a systematic correction of vitamin D deficits.

PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program

PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program Including a Regular Physical Training, a Medical and Nutritional Follow-up, on Adjuvant Hormonal Treatment Compliance in Breast Cancer Patients Over 70 Years.

Compliance rate is defined as the rate of blood samplings of anti-hormone metabolites in the therapeutic range, within the 7 blood samplings distributed in the 3 years of follow-up

Musculoskeletal adverse events will be graded using NCI CTC version 4.0

Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire

Using Mini Nutritional Assessment, weight, weight loss, albuminemia

issued from the exhaustive list of documented concomitant medications

Hospices Civils de Lyon

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Wasting Syndrome

Cachexia

Syndrome

Weight Loss

Body Weight

Body Weight Changes

Thinness

Metabolic Diseases

Nutrition Disorders

Supervised patient-tailored intensity-modulated physical training

1. Supervised Physical Training in SeniorGym for 12 weeks: 1) Aerobic exercise: Patient-tailored intensity-modulated ergometer training for the limbs; 2) Resistance exercise: Patient-tailored resistance exercise by Theraband for the limbs
2. Nutrition intervention for 24 weeks: Dietitian consultation, education and intervention for 24 weeks

Physical training

Chih Chieh Yen, MD

Yi Hsuan Lin

Jui Hung Tsai, MD

I Ting Liu, MD

Ying Tzu Huang, MD

Shuen Ru Yang, MD

Sheng Fu Liang, Ph.D.

Li Chieh Kuo, Ph.D.

Chih Chun Lin, Ph.D.

The goal of the clinical trial is to evaluate the feasibility and efficacy of physical training for elderly cancer patients at risk of cancer cachexia. The main questions it aims to answer are:

* Whether a physical training program is feasible in elderly cancer patients with cachexia?
* What is the efficacy of a physical training program in reducing the severity of cancer cachexia in elderly cancer patients?

Participants will receive a 12-week supervised patient-tailored intensity-modulated physical training and being assessed for the severity of cancer cachexia before and after the training.

The trial is to investigate the feasibility and efficacy of an artificial intelligence-based patient-tailored intensity-modulated physical training for cancer patients aged over 65 at risk of cancer cachexia. The primary endpoint is simplified cancer CAchexia SCOre (MiniCASCO) reduction. Secondary endpoints include geriatric assessment, physical activity and sarcopenia. This is an open-label, single-arm, single-center phase II investigator-initiated trial. The investigators assume a reduction of MiniCASCO by 10% after trial intervention. Under a statistical power of 80% and a probability of type I error at 0.1 (two-tailed), a minimal of 49 participants will be enrolled. All participants will receive a 12-week supervised physical training and nutritional intervention. Efficacy assessments will be conducted at baseline (week 0), post-intervention (week 12) and follow-up period (week 24). The investigators anticipate that the optimal patient-tailored training program is feasible and improves the symptoms and severity of elderly cancer cachexia. The results may shed light on the debilitating and burdensome condition and provide information on future clinical trials.

Physical Training for Elderly Cancer Patients With Cachexia

Physical Training for Elderly Cancer Patients With Cachexia (TEECH-01): a Prospective Clinical Trial

The study protocol, statistical analysis plan and individual information are to be shared upon reasonable request to the study principal investigator.

Health-related quality of life:

A total of 10 standardized questions from EORTC-QLQ C30 are asked to the participants. The answers are graded as none/not at all, a little/slightly, average/moderately, or a lot/considerably and each question is given 0, 0.25, 0.75 or 1.0 point, respectively. A sum-up score of 0 to 10 will be recorded and of those with a greater score indicate a poorer quality of life.

Nutrition:

A total of six questions on food intake, weight loss, mobility, psychological stress/acute disease, the presence of dementia/depression, and body mass index will be graded. A total score, ranging from 0 to 14, will be recorded and of those with a score ≤ 11 indicate a nutritional deficit.

A simplified version for the scoring of the severity of cancer cachexia:

A total score of 0 to 100 points are recorded and graded as minimal (0 to 14), mild (15 to 28), moderate (29 to 46) or severe cachexia (47 to 100)

Geriatric assessment:

A total of 6 domains (cognitive, mobility, nutrition, visual, hearing and depressive symptoms) are included and be given a score of 1 on each if screened positive (a total score from 0 to 6). Of those who scored greater than 2 will be considered "impaired".

Hand grip strength, Gait speed, Body mass index, Sit-to-stand, Back stretch, Sit reach, Single leg stand, Up-and-go, 2-minute step, 6-minute walk test and Timed up-and-go:

A total of 11 items will be recorded and calculated for the percentage difference, which is equivalent to the {\[absolute change between week 12 (end of training) and week 0 (trial enrollment) testing result\] / week 0 testing result } x 100 %. A mean percentage difference of the 11 items, ranging from 0 to 100%, will be calculated and of those with a greater mean percentage difference indicate a greater post intervention change.

National Cheng Kung University

National Cheng-Kung University Hospital

Principal investigator

Nervous System Diseases

Brain Neoplasms

This group will undergo a working memory training program (Training A). The children will receive individual memory training based on the computer program Cogmed RM and will be supervised by trained neuropsychologists. Its efficacy in the use with children with cancer has been recently published. The children will undergo 25 training sessions "online"; each session takes about 45 minutes and consists of a selection of various tasks that target the different aspects of working memory.

This group will receive a physical training that can be executed at home (Training B). The training will be based on xbox Kinect games and comprise games and activities such as jump'n'run games, physical training, and dance activities. One training session will last approximately 45 minutes and will be performed 3 days a week over a period of 8 weeks (in total 25 sessions).

This group will serve as a waiting control group and will receive either the physical or the working memory training program after completion of the Neuropsychological Assessment II

(Training Details already described above)

Working Memory Training

Physical Training

Kurt Leibundgut, MD Prof

Cancer survival comes at a price: pediatric cancer survivors have a high risk for a wide range of cognitive difficulties, particularly survivors of cancer involving the central nervous system (CNS, e.g., brain tumors \[BT\]) are prone to neurocognitive impairments in areas such as executive functions, working memory, attention, memory, visuospatial and motor skills, processing speed as well as language. The aim of this interdisciplinary longitudinal study is to extend empirical knowledge on training and transfer effects in children with a history of cancer. It is hypothesized that early cognitive and physical interventions affect the remediation of pediatric cancer survivors in terms of cognitive functions. These changes are further hypothesized to be associated with white matter changes.

Aims and Hypotheses:

The overall purpose of this study is threefold: first, this study aims to deepen the knowledge about particular patterns of long-term cognitive impairment in pediatric cancer survivors. Understanding the nature of cognitive deficits in this population will be helpful for developing tailored therapeutic strategies. Second, the availability of well-designed child-friendly evidence-based training is of major clinical relevance to prevent school problems and further decline of cognitive functions. Third, the detection of training-induced neuronal changes in white-matter structure will give insight into the functional plasticity of the child's brain. In addition, training-induced changes in white matter would build strong evidence for the effect of the particular intervention.

The following hypotheses will be assessed in particular in the present study:

1. Children with history of brain tumors (BT) show particular problems in memory and attention, resulting in a general deficit in several cognitive areas. Children with a history of cancer without involvement of the CNS show fewer problems than children with a history of cancer with BT in the same cognitive domains but more problems than healthy control children.
2. Standardized working memory training leads to improvement of working memory performance. Transfer of the training effect especially to the areas of executive functions, memory and attention is expected.
3. Physical training leads to improvement of coordination, endurance and motor strength. A transfer to several cognitive areas (i.e. executive functions) and physical self-concept is expected.
4. After working memory training and physical training, the white matter structure of the patients will show significant changes in fractional anisotropy. There will also be changes in functional connectivity.
5. Neuropsychological effects of training will still be present after 6 months post training for both experimental groups.

All comparisons will be carried out on an individual level (intra-individual level, primary objective) as well as on an inter-individual level (between-groups comparisons, secondary objective). The level of significance is set to α = 0.05.

Participants:

Cancer Survivors: Researchers will include 150 children and adolescents aged 7-16 years who received an initial diagnosis of cancer with / without CNS (central nervous system) involvement in the past 10 years and terminated their treatment (surgery, radiation, and / or chemotherapy) at least 12 months prior to their participation in the study. Cancer survivors will be recruited at two different specialized pediatric units in Switzerland. In order to minimize the heterogeneity of the sample, children with a history of cancer without CNS involvement and only surgical removal of the tumor without subsequent radiation and / or chemotherapy will be excluded from the study. Because of the increased likelihood of drop-out of children with a history of cancer in a longitudinal study, more than the statistically required quantity of participants (\> 25 children per group) will be recruited to reach sufficient statistical power.

Healthy Controls: 40 healthy children and adolescents (matched for age and gender) will be included in the first assessment and serve as a healthy control sample. They will be recruited mainly via their siblings, who are included in the cancer survivor group and also from personal acquaintances among hospital staff and the study collaborators.

Design The present study is designed as a randomized stratified controlled trial including two intervention groups, one waiting group (children with a history of cancer \[both CNS+ and CNS-\] and a healthy control group (matched for age and gender). Some children of the patient group will be allocated to a waiting-control group to determine the training effects (their training starts later on). After random assignment to the respective conditions, the interventional material (XBOX or computer), will be installed at the participants home. Thereby, a supervised first training session will take place. The executive functions before and after as well as more details on the effects of a single intervention session (on enjoyment, arousal etc.) will be examined. Subsequently, the respective group will either follow a standardized, computerized working memory training or a physical training. Neuropsychological assessment will be carried out before the intervention / training and re-performed with all participants at the end of the memory training or physical training and at 6 months posttraining. Structural and functional imaging will be performed prior and shortly after working memory training and physical training. A 3 Tesla whole body MRI system will be used (Siemens; Erlangen, Germany). Anatomical imaging will be obtained using a sequence for T1 weighted structural brain imaging with whole brain coverage. Structural connectivity images will be acquired by using a q-ball sequence, functional connectivity will be measured by using a multiband echo planar imaging sequence (MB EPI). Pre- and post-processing of the structural data will be performed using SPM8 (Welcome Departement of Imaging Neuroscience, London) and MATLAB programs (MATLAB version 8.2). In order to perform functional connectivity analyses, the CONN fMRI connectivity toolbox 13.1 (Whitfield-Gabrieli \& Nieto-Castanon, 2012) is used. The fractional anisotropy maps are provide by the Siemens software and can be directly used for further statistical evaluation.

Interventions:

All 150 participants with a history of cancer will be randomly but in a stratified manner assigned to 3 groups (group A, B and C) (see Fig.1).

Training A: Group A (n1= 25 CNS+, n2 = 25 CNS-) will undergo working memory training program. The children will receive individual memory training based on the computer program Cogmed RM (Klingberg et al., 2005) and will be supervised by trained neuropsychologists. Its efficacy in the use with children with cancer has been recently published (e.g. Hardy et al., 2012). The children will undergo 25 training sessions "online"; each session takes about 45 minutes and consists of a selection of various tasks that target the different aspects of working memory. The difficulty level of the training is always adjusted based on the user's performance. The children will perform the memory training program at home over a period of 8 weeks. The child and a licensed Cogmed RM coach (neuropsychologist) will review and monitor the results of each day's training online. In an initial session at the Hospital (Zurich or Bern) the Cogmed RM coach plans and structures the training together with the child and the parents. The coach will provide weekly supervision and feedback on the child's performance and progress via phone call to the child's home. In the closing session with the child and the parents, the training experience will be reviewed .

Training B: Group B (n1= 25 CNS+, n2 = 25 CNS-) will receive a physical training that can be executed at home. The training will be based on xbox Kinect games (e.g. Shape Up) and comprise games and activities such as jump'n'run games, physical training, and dance activities. All material will be provided by the Inselspital Bern. One training session will last approximately 45 minutes and will be performed 3days a week over a period of 8 weeks.

Group C (n1= 25 CNS+, n2 = 25 CNS-) will serve as a waiting control group and will receive either the physical or the working memory training program after completion of the Neuropsychological Assessment II.

Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors

The primary endpoint in this study will be the participant's scores in executive functions based on the model of Miyake et al. (2000) which will be assessed using two different subtests: The subtest Block Recall from the Working Memory Test Battery for Children, WMTB-C (Pickering \& Gathercole, 2001) and the Color-Word Interference Test from the Delis-Kaplan Executive Function System™ (D-KEFS™, (Delis, Kaplan, \& Kramer, 2001).These tests will be administered at each neuropsychological testing, specifically, before and after the training intervention. It is expected to find a statistically significant amelioration in performance after the intervention (effect size f = 0.14 at a level of significance of α =0.05).

Insel Gruppe AG, University Hospital Bern

Routine information on the benefit of physical activity

High-intensity interval and strength training during neoadjuvant chemotherapy

Participants randomized to the exercise group will complete two structured 60-min exercise sessions per week from initiation of NACT to surgery (approx. five months).

Jana de Boniface

Cecilia Haddad Ringborg

Eva Zopf

Peeter Karihtala

Eeva Juhanoja

Jenny Heiman

Jenny Heiman, MD, PhD

Per Nyman

Renske M Altena

Renske Altena

Jana de Boniface, MD, PhD

Sara Margolin

Anna-Karin Wennstig

Hanna Röjlar

Yvette Andersson

Frankie Brown

Marios Tasoulis

Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT surgical histopathology. While it is known that physical exercise can help patients to better tolerate and complete often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes.

The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are residual cancer burden, radiological tumour response, patient-related outcomes (health-related quality of life, physical activity), physiological outcomes (muscle strength, cardiorespiratory fitness), cancer treatment-related toxicities (cognitive dysfunction, chemotherapy completion rates) and long-term sick leave. Furthermore, the trial will explore how physical exercise affects anti-tumoral mechanisms inherent to therapy or host by hypothesis-generating translational analyses.

712 patients with primary invasive breast cancer will be randomized to either a supervised intervention of high-intensity interval and resistance training during NACT, supported by an exercise app, or to usual care, and followed for two years. Physical activity is meticulously tracked. By offering patients active involvement, the trial contributes strongly to the concept of personalized medicine.

The Neo-ACT assesses the primary endpoint pathological complete response (pCR) and the secondary endpoints Residual Cancer Burden (RCB), objective tumour response (RECIST), all-cause, breast cancer-specific, and recurrence-free survival at 2, 5 and 10 years, health-related quality of life assessed by the EORTC QLQ-C30 and BR23 questionnaires, self-reported physical activity (Modified Godin Leisure Time Physical activity questionnaire), toxicity-related outcomes (chemotherapy completion rates, number of unplanned hospital admissions during NACT, objective cognitive dysfunction (Amsterdam Cognition Scan), cardiac toxicity and sick leave), device-measured physical activity level (Fitbit activity tracker), muscle strength (handgrip strength test and hypothetical 1-RM maximal leg muscle strength tests), and cardiorespiratory fitness (Ekblom-Bak submaximal cycle test).

Participants randomized to the exercise group will complete 120 min exercise sessions per week from initiation of NACT to surgery (approx. five months):

* Progressive home exercise program by an individualised mobile phone application, supported by local physiotherapists
* Initial exercise intensity individually tailored to each patient's fitness at baseline and rate of perceived exertion during the program and adapted if required
* Sessions will begin with a 3-minute moderate intensity (12-13 on Borg's Rate of Perceived Exertion (RPE) scale) warm-up.

Randomization to supervised high-intensity interval training during neoadjuvant chemotherapy or usual information about physical activity.

Physical Exercise During Preoperative Chemotherapy for Breast Cancer

Physical Exercise During Neoadjuvant Chemotherapy for Breast Cancer as a Means to Increase Pathological Complete Response Rates: the Randomized Neo-ACT Trial

IPD will be available after study completion upon reasonable request submitted to the PI and with all legal and ethical requirements being fulfilled.

Absence of residual invasive tumor in breast and axilla at surgery

assessed by the EORTC QLQ-C30 questionnaire

assessed by the EORTC QLQ-B23 questionnaire

Modified Godin Leisure Time Physical activity questionnaire

proportion of participants receiving the planned number of treatments

total dose of NACT received to account for potential dose reduction

online neuropsychological test (Amsterdam Cognition Scan)

hypothetical 1-RM maximal leg muscle strength test

Karolinska Institutet

Ass. Prof, PI

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Physical training three times a week for 20 week including endurance and strength training compare to the "as usual" group as controls

As usual

Elisabeth Edvardsen, PhD

The purpose of the study is to investigate the change in pulmonary function and exercise capacity in lung cancer patients after pulmonary resection. Furthermore, to study the effect of training on aerobic capacity, muscular strength, morbidity and survival. Physical activity level by accelerometers, body composition by DXA and quality of life will also be reported.

Five year after surgery, all included patients will be reinvited to undergo a fourth health excame to study the long-term effects of exercise training on physical fitness, morbidity and survival.

Fitness, Activity and Lung Cancer Study

Cardiorespiratory Fitness and Effect of Training After Lung Cancer Surgery. A Randomized Controlled Trial

Change in body composition from before to after surgery and after the intervention

Change in quality of life from before to after surgery and after the intervention

Physical activity will be objectively measured by accelerometers for seven consecutive days to determine change in activity level after surgery

Change in VO2max from before to after surgery to measure the effect of surgery, and after six months to measure the effect of high-intensity training intervention, and after five years to study long-term effects

Change in pulmonary function from before to after surgery and after the intervention

Norwegian School of Sport Sciences

University Hospital, Akershus

Vestre Viken Hospital Trust

Oslo University Hospital

Prinsipal Investigator

Behaviors and Mental Disorders

Cognitive Dysfunction

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Imidacloprid

The mindfulness-based intervention adheres to a standardized protocol developed from the MBSR curriculum (Kabat-Zinn, 1990). The program consists of four 3h group sessions spread over 8 weeks. Each session consists of guided experiential mindfulness exercises (e.g. focus on the breath, body scan, breathing space, mindful movement, sitting meditation), sharing of experiences of these exercises, reflection in small groups, psycho-education (e.g. stress, depression, fear of cancer recurrence, self-care) and review of home practices.

Mindfulness

This intervention is based on the recommended levels of physical activity for adults aged 18 - 64 year from the World Health Organization. These recommendations are the same for women after a breast cancer treatment (Schmitz et al., 2010). Just as the mindfulness intervention this will consist of four 2h group sessions spread over 8 weeks. Each session will consist of psycho-education (e.g. basics of movement, advantages of physical activity, training-principles), endurance and resistance training, stretching, balance and relaxation exercises, sharing of experiences of these exercises and review of home practices.

Katleen Van der Gucht, PhD

Sabine Deprez, PhD

Background: Mindfulness has been applied to improve after cancer care by enhancing psychological well-being; however, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening brain functional connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast-cancer patients after chemotherapy.

Methods: The present study is a three-group randomized controlled trial with assessments at baseline, one-three weeks after the intervention and at three months follow-up. One hundred twenty breast cancer patients who ended treatment minimum 6 months and maximum 5 years before and who have cognitive complaints will be enrolled. They will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group (n=40), (2) an active control condition based on physical training (n=40), or (3) a waitlist control group (n=40). Both the mindfulness-based intervention and the active control condition exist of four group sessions (3 hours for the mindfulness condition and 2 hours for the physical training) spread over 8 weeks. The primary outcomes will be cognitive complaints as measured by the cognitive failure questionnaire and changes in brain functional connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging, and (4) inflammation.

Discussion: The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast-cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer.

Cancer Related Cognitive Impairment After Chemotherapy: Evaluation of Potential Therapeutic Interventions

A Mindfulness-based Intervention for Breast-cancer Patients With Cognitive Impairment After Chemotherapy: Study Protocol of a Three-Group Randomized Controlled Trial

Change in scores on the Cognitive failure questionnaire

KU Leuven

Senior Investigator at Leuven Mindfulness Centre | KU Leuven

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Quality of Life

Neuroepithelioma

The study patients complete two training sessions per week (60 minutes each) under supervision (16 weeks)

One training sessions includes an interval training on a bicycle ergometer. The second one is a strength training with exercise machines. Both trainings are supplemented by coordinative aspects.

Personal Training Program

Dorothee Wiewrodt, PD Dr. med.

Johanna Jost, M.Ed.

The aim of the present study is the prospective controlled use of physical activity in a collective of patients with glioblastoma after surgery and concomitant radiation/chemotherapy and during adjuvant cytotoxic therapy. The research question is whether physical exercise is feasible and whether patients benefit physically and mentally from the activities performed. For this purpose, specific training units under the supervision of a certified trainer and sports scientist as well as standardized sports medical test procedures are implemented. Beyond the instructed training, general physical activity phases are recorded electronically using a pedometer/activity tracker, which is worn at all times.

It will be examined whether the individual training program

1. improves physical fitness
2. increases quality of life/life satisfaction throughout the intervention
3. can be detected in blood due to increased concentrations of brain-derived neurotrophic factor 1 (BDNF-1) (voluntary)

The measurements should be taken before and 8, 16 and 24 weeks after the start of training.

The personal trainers of the university clinics in Bochum and Homburg/Saar receive specific training activities from Münster's trainer Ralf Brandt in order to ensure a standardized concept. This way, a comparison of the trainings' conduction and recording is possible both quantitatively and qualitatively.

Physical Training in Glioblastoma Patients During Cytotoxic Therapy

Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients

Evidence of a significant increase (at least 15%) in physical work \[watt/kilogram bodyweight\] at PWC75% of maximum heart rate.

PWC stratified according to:

* age (\<40, 40-60, \>60 years)
* Karnofsky performance status (KPS) (70-80 vs. 90-100 %)
* Gender
* PWC test 130, 150, (170)

Changes in the maximal oxygen consumption (measured during spiroergometry)

Changes in the individual anaerobic lactate threshold (measured during spiroergometry)

Changes in Health Related Quality of Life (HRQoL) using a standardized questionnaire; The EORTC QLQ-C30 questionnaire contains 30 questions and assesses the quality of life of oncology patients multidimensionally across 10 subscales. Times of measurement in week 0, 4, 8, 16, 20 and 24.

Changes in Health Related Quality of Life (HRQoL) using a standardized questionnaire; scale from 1 (not stressed at all) to 10 (extremly stressed); Times of measurement in week 0, 4, 8, 16, 20 and 24.

Changes in Health Related Quality of Life (HRQoL) using a standardized questionnaire; The Hospital Anxiety and Depression Scale (HADS) is a self-rating scale developed to assess psychological distress in non-psychiatric patients. It consists of two subscales, anxiety and depression (14 items); Times of measurement in week 0, 4, 8, 16, 20 and 24.

University Hospital Muenster

Hormones

Physical fitness evaluation followed by prescribed physical activity and progress reporting.

Tailored Wii Fit prescription based on physical fitness assessments and a schedule of six home visits by an oncology RN.

Six Week Physical Activity Intervention

Participants will keep a log to record the physical activities they have done with the Wii Fit during the 6-week period. Audio-recording may be included for quality control. Self-report data will be collected by Internet surveys through the University of South Florida (USF) Health Qualtrics application at baseline (T1) and at 6 weeks post-intervention (T2). The nurse will take small amount of the participant's hair (20 strands) for a hormone test during the first visit and last visit.

Progress Reporting

Hsiao-Lan Wang, Ph.D., RN

The purpose of this study is to understand if a home-based physical activity program can improve symptoms and physical function among patients with advanced stage cancer.

This program includes use of the Nintendo Wii Fit™Plus (Wii Fit) and home visits by a nurse. The same nurse will attend all of the visits.

Physical Activity for Advanced Stage Cancer Patients

Feasibility and acceptability of a tailored Wii Fit intervention. Hypothesis1.1: 60% of eligible patients will enroll; 1.2: 60% of participants will adhere to their tailored physical activity prescriptions; 1.3: 70% of participants will agree that Wii Fit is easy to use, enjoyable, convenient, and helpful.

Enrollment rate: ratio of number of advanced stage cancer patients enrolled in the study to total number of patients meeting eligibility criteria invited to participate in the study. Adherence rate: ratio of the number of participants who adhere to the tailored Wii Fit prescription (i.e., expend at least 60% of prescribed kilocalories each week) to the total number of participants in the study. Acceptability of and satisfaction with the intervention: ratio of number of participants whose mean scores of Wii Fit and RN Visiting Surveys are equal to or more than 3 on 1-4 Likert-type scale to the total number of participants in the study.

Examine changes in outcomes (fatigue, pain, depression, anxiety, sleep quality, physical function, perceived stress, and chronic Hypothalamus-Pituitary-Adrenal (HPA) activation) over 6 weeks among patients who have the intervention. Hypothesis 2.1: There will be positive changes in the outcomes.

Repeated measures ANOVA will be used to compare T1 with T2 scores in fatigue, pain, depression, anxiety, sleep quality, physical function, perceived stress, and hair cortisol. Twenty participants will provide 80% power to detect only large effect sizes (d\>.60), which cannot be anticipated. Because the purposes of this study are to inform future larger studies, the ANOVA will be used to calculate effect sizes (η2) for future power estimations. Because effect size calculation will be the central purpose of the ANOVAs, no adjustment will be made to reduce the possibility of Type 1 errors (p\<.05).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program	NCT02216162	Breast Cancer	Arm A: adapted ... No intervention	70 Years -	Hospices Civils de Lyon
Physical Training for Elderly Cancer Patients With Cachexia	NCT05915325	Geriatric Asses... Cancer Cancer Cachexia	Physical traini...	65 Years -	National Cheng-Kung University Hospital
Efficacy of Cognitive and Physical Trainings in Pediatric Cancer Survivors	NCT02749877	Pediatric Cance...	Working Memory ... Physical Traini...	7 Years - 16 Years	Insel Gruppe AG, University Hospital Bern
Physical Exercise During Preoperative Chemotherapy for Breast Cancer	NCT05184582	Breast Cancer	Physical traini...	18 Years - 100 Years	Karolinska Institutet
Fitness, Activity and Lung Cancer Study	NCT01748981	Lung Cancer	Physical traini... As usual	30 Years - 79 Years	Oslo University Hospital
PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program	NCT02216162	Breast Cancer	Arm A: adapted ... No intervention	70 Years -	Hospices Civils de Lyon
Cancer Related Cognitive Impairment After Chemotherapy: Evaluation of Potential Therapeutic Interventions	NCT03736460	Cognitive Impai...	Mindfulness Physical traini...	18 Years - 65 Years	KU Leuven
Fitness, Activity and Lung Cancer Study	NCT01748981	Lung Cancer	Physical traini... As usual	30 Years - 79 Years	Oslo University Hospital
Fitness, Activity and Lung Cancer Study	NCT01748981	Lung Cancer	Physical traini... As usual	30 Years - 79 Years	Oslo University Hospital
Physical Training in Glioblastoma Patients During Cytotoxic Therapy	NCT05015543	Glioblastoma	Personal Traini...	18 Years -	University Hospital Muenster
Physical Activity for Advanced Stage Cancer Patients	NCT02015936	Cancer	Six Week Physic... Progress Report...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Physical Activity for Advanced Stage Cancer Patients	NCT02015936	Cancer	Six Week Physic... Progress Report...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for physical training