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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02430792
Recruitment Status : Completed
First Posted : April 30, 2015
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
TrygFonden, Denmark
University of Copenhagen
Parker Research Institute
The Danish Football Association
Danish Cancer Society
Information provided by (Responsible Party):
Eik Bjerre, Rigshospitalet, Denmark

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Football Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : May 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Mean change in quality of life from baseline to week 12 [ Time Frame: 12 weeks ]
    Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire


Secondary Outcome Measures :
  1. Mean change in quality of life from baseline to month 6 [ Time Frame: 6 months ]
    Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire

  2. Whole-body bone mineral content percent change from baseline to month 6 [ Time Frame: 6 months ]
    Assessed by dual energy x-ray absorptiometry.

  3. Whole-body bone mineral density percent change from baseline to month 6 [ Time Frame: 6 months ]
    Assessed by dual energy x-ray absorptiometry.

  4. Whole-body lean body mass mean change from baseline to month 6 [ Time Frame: 6 months ]
    Assessed by dual energy x-ray absorptiometry.

  5. Whole-body fat mass mean change from baseline to month 6 [ Time Frame: 6 months ]
    Assessed by dual energy x-ray absorptiometry.

  6. 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

  7. 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

  8. Lumbar spine bone mineral density percent change from baseline to month 6 [ Time Frame: 6 months ]
    Assessed by dual energy x-ray absorptiometry.

  9. Femoral neck bone mineral density percent change from baseline to month 6 [ Time Frame: 6 months ]
    Assessed by dual energy x-ray absorptiometry.

  10. Total hip bone mineral density percent change from baseline to month 6 [ Time Frame: 6 months ]
    Assessed by dual energy x-ray absorptiometry.

  11. 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

  12. 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


Other Outcome Measures:
  1. EQ-5D-5L for use in health economics analysis [ Time Frame: 12 weeks and 6 months ]
  2. 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 ]
  3. Dyadic adjustment [ Time Frame: 12 weeks and 6 months ]
    The seven-item version of the dyadic adjustment scale (DAS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02430792


Locations
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Denmark
Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
Rigshospitalet
København, København N, Denmark, 2200
Odense Universitets Hospital
Odense, Odense C, Denmark, 5000
Sydvestjysk Sygehus, Esbjerg
Esbjerg, Denmark, 6700
Sponsors and Collaborators
Rigshospitalet, Denmark
TrygFonden, Denmark
University of Copenhagen
Parker Research Institute
The Danish Football Association
Danish Cancer Society
Investigators
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Study Director: Julie Midtgaard, Dr Rigshospitalet, Denmark
Principal Investigator: Eik D Bjerre, Msc. Rigshospitalet, Denmark

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eik Bjerre, Msc. PhD. Student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02430792    
Other Study ID Numbers: IDnr. 106471
First Posted: April 30, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Keywords provided by Eik Bjerre, Rigshospitalet, Denmark:
Prostatic Neoplasms
Exercise
Football
Quality of Life
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases