Trial Outcomes & Findings for Prostate Cancer - Patient Empowerment Program (NCT NCT03660085)

Prostate Cancer - Patient Empowerment Program

Proportion of participants scoring ≥20 on the Kessler Psychological Distress Scale-10 (K10) at 6 months after randomization. The K10 is a validated 10-item measure of psychological distress with scores ranging from 10-50, where higher scores indicate worse distress.

The Short Form (SF-12) Health Survey will be used to assess views about general health (physical and mental) quality of life. Change score will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180).Assessment of these measures will also be completed at the end of the study (day 360). Assessed via on-line survey.

The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure psychosocial factors. Changes will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180).Assessment of these measures will also be completed at the end of the study (day 360). Assessed via on-line survey.

The Expanded Prostate Index Composite (EPIC) (urinary, bowel, hormonal and sexual) and I-PSS (urinary) will be used to measure urinary function pre and post intervention. Change score will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180). This will be assessed via on-line survey. Assessment of these measures will also be completed at the end of the study (day 360).

Electroencephalography (EEG) assessment of stress state will be measured using the Muse (IntraXon, Inc. Toronto, Ontario, Canada) neurofeedback device. Averages in relaxation brainwaves activity measurements (e.g. alpha, beta, delta, theta, and gamma) will be taken over listening to 10 minutes of relaxation music and instructions. The difference between scores at baseline (day 0) and post intervention (day 180) will be assessed. Assessment of these measures will also be completed at the end of the study (day 360). Assessment will be performed during study visits.

Heart rate variability (HRV) will be assessed through a HRV monitor produced by HeartMath institute. participants will be given home the device for biofeedback purposes with regards to practicing the meditation training received. The device produces scores of HRV and those at pre- (day 0) will be compared to scores at post intervention (day 180), and also at the end of the study (day 360). This will be assessed via on-line survey.

Dyadic Assessment Scale will be used to assess relationship satisfaction at pre- (day 0) will be compared to scores at post intervention (day 180), and also at the end of the study (day 360).

Starting the conversation diet questionnaire will be used (developed by CHPDP). It will be assessed on-line via a survey (day 0, day 180 and day 360)

This will be assessed online through two questions assessing number of visits to see a health care practitioner, and hospital admissions one year prior to the study and then during the year when the study was conducted.

Pre and post intervention assessment of physical fitness assessed to see how many meters the p\[participant can walk during a timed six-minute walk test. Pre and Post scores will be taken at baseline (day 0 - pre) and post intervention (day 180 post). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.

The length of time (in seconds) of static postural and balance control will be assessed at pre and post intervention, measured in minutes. Change score will be calculated by taking the difference between each of the pre and post measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.

Pre and post intervention participants will be timed for 30 seconds to measure the amount of time they can go from sitting to standing in the allocated 30 seconds. The test will be used to test for lower limb strength. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.

Flexibility of shoulder and hamstring will be assessed recording the distance (in cm) rather than the degrees of the reach. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.

Pre and Post measurements of grip strength using a dynamometer will be used to test the strength of the arm and and hand forearm muscles. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.

The height of the individual will be measured in cm at the start of the program.

The weight of the individual participants will be measured in kg using a manual scale, in kg, at pre and post intervention. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.

Body mass index will be calculated at pre and post intervention using the height and weight scores obtained. The BMI formula we will use is: Kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.