Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Participants in the intervention group will practice soccer for 52 weeks two times weekly. A soccer instructor will be in charge of all training sessions. The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.

Training will take place on a natural grass pitch. In adverse weather conditions (i.e., \< 5°C or heavy rain) training will be performed indoors. Participants will be told to avoid hard tackles and other actions that carry a risk of injury.

Participants in the control group will receive verbal advice about the benefits of exercise and physical activity.

The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.

Training will take place on a natural grass pitch. In adverse weather conditions (i.e., \< 5°C or heavy rain) training will be performed indoors

Football fitness

Late effects of breast cancer treatment are widely reported including deteriorating fitness, fatigue, loss of muscle and bone mass, and increased body fat percentage. Exercise interventions may ameliorate a number of these effects including fatigue, fitness and improve quality of life. However only limited knowledge exists on the potential of novel interventions and settings, such as sports outside the hospital setting, to improve late effects of breast cancer treatment. The 'Football Fitness After Breast Cancer' (FF ABC) study is a randomized trial comparing the effects of a football training intervention with standard treatment approaches on fitness, bone mineralization, body composition, muscle strength, blood pressure, and patient-reported outcomes in women treated for breast cancer.

1/3 of participants will be randomly allocated to the control group and 2/3 of participants will be randomly allocated to the Football fitness intervention group.

Personnel assessing the primary outcome is blinded for study participants group allocation.

Football Fitness After Breast Cancer

A Randomized Controlled Trial to Investigate the Health Promoting Effects of a Football Fitness Intervention for Women After Treatment for Breast Cancer

Incremental test to exhaustion on a cycle ergometer.

Assessed by dual energy x-ray absorptiometry.

Body weight was measured with a digital platform scale.

Dynamic concentric muscle strength for the knee extensors (1RM).

Blood pressure will be measured with a digital sphygmomanometer.

Procollagen type I C propeptide, osteocalcin and C-terminal telopeptide will be analyzed by a chemiluminescence method using a fully automated immunoassay system (iSYS, Immunodiagnostic Systems Ltd., Boldon, England.

Blood samples will be analyzed at baseline, 6 and 12 month for total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, and glycosylated hemoglobin, respectively, by automated analyzers (Cobas Fara, Roche, Neuilly sur Seine, France) using enzymatic kits (Roche Diagnostics, Mannheim, Germany, and Tosoh G7, Tosoh Europe, Tessenderlo, Belgium).

Assessed by the International Physical Activity Questionnaire (IPAQ).

Assessed by the supplement EORTC QLQ-BR23.

Assessed by the 15 subscales of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30).

Assessed by disabilities of the arm, shoulder and hand (DASH).

Assessed by The Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36)

University of Southern Denmark

University of Copenhagen

Postdoc

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quality of Life

Recreational football 1-hour twice weekly in a local football club on a disease specific team

A 15-30-minute guidance session upon group allocation to encourage engagement in the standard rehabilitation offered by the municipality

The football training will consist of sessions of 20 minutes of warm-up exercises. Followed by 20 minutes dribbling, passing, shooting exercises. Ends with 20 minutes of 5-7 a-side games.

Football

Julie Midtgaard, Dr

Eik D Bjerre, Msc.

Prostate cancer is the most common malignancy in men. Three million are currently living in the United States with the disease and this number is expected to rise to four million in 2024. Most live many years with the disease and experience significant morbidity both due to disease progression and treatment toxicity. Exercise has shown to improve QoL and reduce treatment toxicity. Moreover epidemiological evidence has suggested that physical activity improves survival.

Football has been shown to induce positive effects on body composition and bone markers in a subgroup of prostate cancer patients, those receiving androgen deprivation therapy.

The objective is to examine the effectiveness of football in prostate cancer survivors.

PLAN FOR THE STATISTICAL ANALYSES

This plan has been prepared and is laid forward before any follow-ups are conducted. The plan delineates the analyses of the FC PC trial; any deviations will be laid forward and discussed in the final publication.

The primary statistical analysis targets the effect on prostate cancer (PCa) specific Quality of Life (QoL) of a treatment policy offering community based football to men with prostate cancer. In particular, patients will be analysed in the treatment group to which they were randomly allocated respecting the intention-to-treat principle (ITT). The appropriate method for addressing this effect depends on the assumptions made about missing data (drop-outs). Our main analysis is valid under the missing at random assumption but we will also present sensitivity analyses robust to non-ignorable patterns among patients with incomplete data.

Per protocol analyses will be performed to estimate the de jure effect of the treatment for compliant patients. The "per protocol" population will be defined as those trial participants from the intervention group that have attended the football intervention at least 12 times in the first 12 weeks and 24 times in 6 months intervention period.

Significance tests will be two-sided with a maximal type I error risk of 5 %. To address the problem of multiple comparisons for secondary analyses when several outcomes are tested or multiple constracts are extracted from the same statistical model p-values will be adjusted using the step-down Bonferrroni method of Holm (Holm 1979) or appropriate modern alternatives.

Trial profile A CONSORT diagram will show trial participant flow. Number of screened patients fulfilling inclusion criteria and trial subjects included in analyses together with reasons for exclusion of trial subjects will be reported.

Primary outcome The continuous outcome score of FACT-P will be calculated using the official scoring guideline. As described in the scoring guideline missing items will be prorated by multiplying the sum of the subscale with the number of the items in the subscale, then divided by the number of items answered. This will only be done if more than 50% of the items are answered in the subscales and 80% are answered in the total questionnaire. The change score of the total FACT-P at 12 weeks will be calculated by subtracting the total 12 week score from the respective trial participant's baseline score. Analysis of covariance will be used (Vickers and Altman 2001), group and ADT-status will be set as factors, the response will be change in FACT-P and covariates are age and baseline score. The results will be presented as least squares means (LSMEANS) differences between the two groups with 95 % confidence intervals and p-values.

Secondary outcomes including safety outcomes Changes from baseline to 6 month for LBM, BMC, BMD, and total body fat mass will be analysed in the same manner as the primary outcome.

QoL, Functional Well-Being and Physical Activity (based on MET values derived from the IPAQ questionnaire) measured at baseline, 12 weeks and 6 months will be analysed using a mixed model for repeated measurements. Changes from baseline to 12 weeks or 6 months will be treated as the response, the model will include fixed effects of factors: group, ADT, sampling time and their interactions, and the analysis will be adjusted for age and baseline value. The correlation between measurements on the same patient will be modeled using a random effect of patient.

Safety outcomes will be listed for each group and the number of fractures and falls that resulted in seeking medical assessment will be compared across groups using Fisher's exact test.

Subgroup analyses are planned to be reported for the patients treated with androgen deprivation therapy therefore results will be given both for the overall treatment effect and for subgroup obtained by stratifying level of according to androgen deprivation therapy. To verify the credibility of our subgroup analyses, we apply the criteria proposed by Sun and colleagues (Sun et al. 2012), i.e. the subgroup variable is a baseline characteristic, is a stratification factor, is specified a priori and includes only a small number of analyses.

Outline of figures and tables The first figure in the main publication will be a CONSORT flow diagram. The second figure will illustrate changes in the primary and secondary outcomes, except safety outcomes, at 12 weeks and 6 months, according to treatment group.

A third figure will display mean curves for the primary outcome for patients in different groups according to pattern of missing data. In particular, mean curves will be shown separately for completers and patients with missing data at one or more assessment times. The figure will be used to guide the type of sensitivity analyses performed to adjust results for a potentially deviating pattern for patients with incomplete observations.

Tables will be in following order; first a table delineating trial subjects characteristics, secondly a table showing changes in primary and secondary outcomes both at 12 weeks and 6 months. Thirdly safety outcomes will presented according to group and type.

Effectiveness of Community-based Football in Prostate Cancer

Effectiveness of Community-based Football Compared With Usual Care on Quality of Life in Men With Prostate Cancer: the FC Prostate Community Randomized Controlled Trial

The seven-item version of the dyadic adjustment scale (DAS)

Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire

Assessed by the International Physical Activity Questionnaire

Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire, subscale functional well-being

Any fracture includes fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Football Fitness After Breast Cancer	NCT03284567	Breast Neoplasm...	Football fitnes...	18 Years - 75 Years	University of Copenhagen
Football Fitness After Breast Cancer	NCT03284567	Breast Neoplasm...	Football fitnes...	18 Years - 75 Years	University of Copenhagen
Football Fitness After Breast Cancer	NCT03284567	Breast Neoplasm...	Football fitnes...	18 Years - 75 Years	University of Copenhagen
Effectiveness of Community-based Football in Prostate Cancer	NCT02430792	Prostate Cancer	Football	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for football

Every month we try and update this database with for football cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for football

Every month we try and update this database with for football cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for football cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.