Breast Cancer, Fatigue, Physical Activity, Prostate Cancer, Sedentary Behaviour
Conditions
Brief summary
Cancer-related fatigue (CRF) can be experienced by individuals with Prostate Cancer (PC), which can have profound effects on their well-being. Although physical activity has been shown to improve CRF, the recommended levels are generally not met. Step count and distance traveled information can help individuals to increase their physical activity. Wearable technology (WEAR) provides the user with feedback of their physical activity which can motivate behaviour change. Similarly, education workshops (EDU) on the effects of sedentary behaviour and physical activity may also reduce sedentary behaviour. The objectives of this study are to evaluate the effects of WEAR and EDU on sedentary behaviour and CRF, and to explore the feasibility of WEAR in this population. Participants in this study will be randomly assigned into WEAR, EDU, WEAR+EDU, or control over a three-month intervention. Assessments at baseline, post-intervention and a 3-month follow up will evaluate CRF, quality of life and level of sedentary behaviour, and use of WEAR devices. The results from this study will provide evidence-based knowledge on the impact of WEAR and EDU on sedentary behaviour and CRF, and an understanding on the use of technology within the PC population. These results can shape the development of programming for CRF and the use of scale-able technology-based interventions/approaches in this population.
Interventions
OTHERWearable Technology - Garmin Vivosmart
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
OTHEROnline Educational Group
A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour
OTHERWearable Technology - FitBit Alta
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
OTHERWearable Technology - Polar Loop 2
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Sponsors
University of Toronto
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PC survivors aged 18 years or older * Currently sedentary, defined as \<90 minutes per week of activity * Fluent in English * Access to a computer with internet connectivity
Exclusion criteria
• Men who are or have received chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome measures captured | 6 month assessment (follow-up) | This will be measured through review and analysis of data obatined for completeness |
| Recruitment rate | Baseline | At baseline we will evaluate the recruitment rate of participants for the feasibility of this trial and reasons for declining to participate |
| Retention rate | 3 month assessment (Post-Intervention) | At the end of the intervention and follow-up assessment, we will measure retention rate through number of participants who have withdrawn from the study. |
| Adherence | 3 month assessment (Post-Intervention) | Adherence will be measured for participants attendance throughout the intervention. |
| WEAR device preference | 3 month assessment (Post-Intervention) | This will be measured through the number of participants that choose each of the three devices. |
| Acceptability | 6 months assessment (follow-up) | Acceptability will be measured through the end of study questionnaire at the follow-up assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sedentary Behaviour | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | Assessed through accelerometry and Sit-Q 7 Day questionnaire |
| Quality of Life | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | Assessed with Functional Assessment of Cancer Therapy - General (FACT-G) |
| Depression | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | Assessed with Patient Health Questionnaire - 9 (PHQ-9) |
| Understand attitudes towards using wearable technology | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | Assessed through semi-structured interviews |
| Cancer-Related Fatigue | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | Assessed with Functional Assessment of Cancer Therapy - Fatigue (FACT-F) |
Countries
Canada
Outcome results
None listed