Effectiveness of Community-based Football in Prostate Cancer (FC-PC)

March 12, 2018 updated by: Eik Bjerre, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
214

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Esbjerg, Denmark, 6700
        • Sydvestjysk Sygehus, Esbjerg
    • Aarhus N
      • Aarhus, Aarhus N, Denmark, 8200
        • Aarhus University Hospital
    • København N
      • København, København N, Denmark, 2200
        • Rigshospitalet
    • Odense C
      • Odense, Odense C, Denmark, 5000
        • Odense Universitets Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Diagnosed with prostate cancer
  • Age ≥18 years
  • Able to read and understand questionnaires in Danish
  • Signed informed consent

Exclusion Criteria:

  • <6 weeks after prostatectomy
  • Football training disencouraged by primary physician
  • Osteoporosis (T-score < -2,5) assessed by Dual Energy X-Ray Absorptiometry at baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Football
Recreational football 1-hour twice weekly in a local football club on a disease specific team
Behavioral: Football
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.
NO_INTERVENTION: Control
A 15-30-minute guidance session upon group allocation to encourage engagement in the standard rehabilitation offered by the municipality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean change in quality of life from baseline to week 12
Time Frame: 12 weeks
Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean change in quality of life from baseline to month 6
Time Frame: 6 months
Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire
6 months
Whole-body bone mineral content percent change from baseline to month 6
Time Frame: 6 months
Assessed by dual energy x-ray absorptiometry.
6 months
Whole-body bone mineral density percent change from baseline to month 6
Time Frame: 6 months
Assessed by dual energy x-ray absorptiometry.
6 months
Whole-body lean body mass mean change from baseline to month 6
Time Frame: 6 months
Assessed by dual energy x-ray absorptiometry.
6 months
Whole-body fat mass mean change from baseline to month 6
Time Frame: 6 months
Assessed by dual energy x-ray absorptiometry.
6 months
Self-reported physical activity from baseline to week 12 and month 6
Time Frame: 12 weeks and 6 months
Assessed by the International Physical Activity Questionnaire
12 weeks and 6 months
Self-reported functional well-being from baseline to week 12 and month 6
Time Frame: 12 weeks and 6 months
Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire, subscale functional well-being
12 weeks and 6 months
Lumbar spine bone mineral density percent change from baseline to month 6
Time Frame: 6 months
Assessed by dual energy x-ray absorptiometry.
6 months
Femoral neck bone mineral density percent change from baseline to month 6
Time Frame: 6 months
Assessed by dual energy x-ray absorptiometry.
6 months
Total hip bone mineral density percent change from baseline to month 6
Time Frame: 6 months
Assessed by dual energy x-ray absorptiometry.
6 months
Number of participants with any fracture from baseline to month 6
Time Frame: 6 months
Any fracture includes fractures at any site excluding skull, facial, mandible, metacarpals, finger phalanges, and toe phalanges
6 months
Number of participants with falls that resulted in seeking medical assessment from baseline to month 6
Time Frame: 6 months
Any falls for which participants report to obtain medical treatment
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EQ-5D-5L for use in health economics analysis
Time Frame: 12 weeks and 6 months
12 weeks and 6 months
Medical outcomes study 12-item short-form health survey(SF-12), version 2 for use in health economics analysis
Time Frame: 12 weeks and 6 months
12 weeks and 6 months
Dyadic adjustment
Time Frame: 12 weeks and 6 months
The seven-item version of the dyadic adjustment scale (DAS)
12 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rigshospitalet, Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Parker Research Institute
Danish Cancer Society
TrygFonden, Denmark
The Danish Football Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Julie Midtgaard, Dr, Rigshospitalet, Denmark
  • Principal Investigator: Eik D Bjerre, Msc., Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IDnr. 106471

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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