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History of Changes for Study: NCT02430792
Effectiveness of Community-based Football in Prostate Cancer (FC-PC)
Latest version (submitted March 12, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 27, 2015 None (earliest Version on record)
2 May 20, 2015 Recruitment Status, Study Status and Contacts/Locations
3 November 16, 2015 Contacts/Locations, Study Status and Study Description
4 October 3, 2016 Study Status
5 November 8, 2016 Contacts/Locations, Study Status and References
6 March 6, 2017 Recruitment Status, Study Status and Contacts/Locations
7 July 19, 2017 Study Status and Contacts/Locations
8 March 12, 2018 Recruitment Status, Study Status and Study Design
Comparison Format:

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Study NCT02430792
Submitted Date:  April 27, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: IDnr. 106471
Brief Title: Effectiveness of Community-based Football in Prostate Cancer (FC-PC)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2015
Overall Status: Not yet recruiting
Study Start: May 2015
Primary Completion: August 2017 [Anticipated]
Study Completion: November 2017 [Anticipated]
First Submitted: April 27, 2015
First Submitted that
Met QC Criteria:
April 27, 2015
First Posted: April 30, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 27, 2015
Last Update Posted: April 30, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Rigshospitalet, Denmark
Responsible Party: Principal Investigator
Investigator: Eik Bjerre
Official Title: Msc. PhD. Student
Affiliation: Rigshospitalet, Denmark
Collaborators: TrygFonden, Denmark
University of Copenhagen
Parker Research Institute
The Danish Football Association
Danish Cancer Society
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Detailed Description:
Open or close this module Conditions
Conditions: Prostate Cancer
Keywords: Prostatic Neoplasms
Exercise
Football
Quality of Life
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Supportive Care
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
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)
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Eik J Bjerre, Msc.
Telephone: +45 35457917
Email: eb@ucsf.dk
Central Contact Backup: Ditte Marie Bruun, Msc.
Telephone: +45 35457367
Email: dmb@ucsf.dk
Study Officials: Julie Midtgaard, Dr
Study Director
Rigshospitalet, Denmark
Locations: Denmark, Aarhus N
Aarhus University Hospital
Aarhus, Aarhus N, Denmark, 8200
Contact:Contact: Helene H Pedersen 45 78 45 26 38 helene.holm@skejby.rm.dk
Contact:Principal Investigator: Michael Borre, Dr
Denmark, København N
Rigshospitalet
København, København N, Denmark, 2200
Contact:Contact: Eik J Bjerre, Msc +45 35457917 eb@ucsf.dk
Contact:Contact: Ditte Marie Bruun, Msc +4535457367 dmb@ucsf.dk
Contact:Principal Investigator: Eik J Bjerre, Msc
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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