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)

Table 3 Outcomes with specified measurement variable, analysis metric, method of aggregation and time point

Concept	Specific measurement variable	Patient- level analysis metric	Method of aggregation	Time point(s)
Primary outcome
Quality of life	Functional Assessment of Cancer Therapy - Prostate Questionnaire	Change from baseline	Mean	12 week
Secondary outcomes
Quality of life	Functional Assessment of Cancer Therapy - Prostate Questionnaire	Change from baseline	Mean	6 month
Muscle mass	Whole-body lean body mass	Change from baseline	Mean	6 month
Fat mass	Whole-body fat mass	Change from baseline	Mean	6 month
Whole body bone strength	Whole-body bone mineral content	Change from baseline	Mean percent	6 month
Whole body bone strength	Whole-body bone mineral density	Change from baseline	Mean percent	6 month
Self-reported physical activity	International Physical Activity Questionnaire	Change from baseline	Mean	12 week and 6 month
Functional well-being	Subscale from Functional Assessment of Cancer Therapy-Questionnaire	Change from baseline	Mean	12 week and 6 month
Regional bone strength	Lumbar spine bone mineral density	Change from baseline	Mean percent	6 month
	Femoral neck bone mineral density	Change from baseline	Mean percent	6 month
	Total hip bone mineral density	Change from baseline	Mean percent	6 month
Safety	Participants with any fracture	Number in each group	Proportion	6 month
Safety	Participants with falls that resulted in seeking medical assessment	Number in each group	Proportion	6 month
Exploratory outcomes
Dyadic adjustment	DAS-7	Change from baseline	Median	12 week and 6 month

ISSN: 1471-2407