NCT02430792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started May 2015

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2.3 years

First QC Date

April 27, 2015

Last Update Submit

March 12, 2018

Conditions

Prostate Cancer

Keywords

Prostatic NeoplasmsExerciseFootballQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Mean change in quality of life from baseline to week 12

    Assessed with Functional Assessment of Cancer Therapy - Prostate Questionaire

    12 weeks

Secondary Outcomes (12)

  • Mean change in quality of life from baseline to month 6

    6 months

  • Whole-body bone mineral content percent change from baseline to month 6

    6 months

  • Whole-body bone mineral density percent change from baseline to month 6

    6 months

  • Whole-body lean body mass mean change from baseline to month 6

    6 months

  • Whole-body fat mass mean change from baseline to month 6

    6 months

  • +7 more secondary outcomes

Other Outcomes (3)

  • EQ-5D-5L for use in health economics analysis

    12 weeks and 6 months

  • Medical outcomes study 12-item short-form health survey(SF-12), version 2 for use in health economics analysis

    12 weeks and 6 months

  • Dyadic adjustment

    12 weeks and 6 months

Study Arms (2)

Football

ACTIVE COMPARATOR

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

Behavioral: Football

Control

NO INTERVENTION

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

Interventions

FootballBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

Location

Rigshospitalet

Copenhagen, København N, 2200, Denmark

Location

Odense Universitets Hospital

Odense, Odense C, 5000, Denmark

Location

Sydvestjysk Sygehus, Esbjerg

Esbjerg, 6700, Denmark

Location

Related Publications (5)

  • Bjerre E, Bruun DM, Tolver A, Brasso K, Krustrup P, Johansen C, Christensen R, Rorth M, Midtgaard J. Effectiveness of community-based football compared to usual care in men with prostate cancer: Protocol for a randomised, controlled, parallel group, multicenter superiority trial (The FC Prostate Community Trial). BMC Cancer. 2016 Oct 3;16(1):767. doi: 10.1186/s12885-016-2805-0.

    PMID: 27716218BACKGROUND

  • Midtgaard J, Tjornhoj-Thomsen T, Rorth M, Kronborg M, Bjerre ED, Oliffe JL. Female partner experiences of prostate cancer patients' engagement with a community-based football intervention: a qualitative study. BMC Public Health. 2021 Jul 15;21(1):1398. doi: 10.1186/s12889-021-11448-7.

    PMID: 34266389DERIVED

  • Bjerre ED, Weller S, Poulsen MH, Madsen SS, Bjerre RD, Ostergren PB, Borre M, Brasso K, Midtgaard J. Safety and Effects of Football in Skeletal Metastatic Prostate Cancer: a Subgroup Analysis of the FC Prostate Community Randomised Controlled Trial. Sports Med Open. 2021 Apr 20;7(1):27. doi: 10.1186/s40798-021-00318-6.

    PMID: 33877496DERIVED

  • Bjerre ED, Petersen TH, Jorgensen AB, Johansen C, Krustrup P, Langdahl B, Poulsen MH, Madsen SS, Ostergren PB, Borre M, Rorth M, Brasso K, Midtgaard J. Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial. PLoS Med. 2019 Oct 1;16(10):e1002936. doi: 10.1371/journal.pmed.1002936. eCollection 2019 Oct.

    PMID: 31574097DERIVED

  • Bjerre ED, Brasso K, Jorgensen AB, Petersen TH, Eriksen AR, Tolver A, Christensen JF, Poulsen MH, Madsen SS, Ostergren PB, Borre M, Krustrup P, Johansen C, Rorth M, Midtgaard J. Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial): A Pragmatic Multicentre Randomized Controlled Trial. Sports Med. 2019 Jan;49(1):145-158. doi: 10.1007/s40279-018-1031-0.

    PMID: 30506427DERIVED

Related Links

MeSH Terms

Conditions

Prostatic NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesBehavior

Study Officials

  • Julie Midtgaard, Dr

    Rigshospitalet, Denmark

    STUDY DIRECTOR

  • Eik D Bjerre, Msc.

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc. PhD. Student

Study Record Dates

First Submitted

April 27, 2015

First Posted

April 30, 2015

Study Start

May 1, 2015

Primary Completion

September 1, 2017

Study Completion

February 1, 2018

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations

DK(4)