Reducing Sedentary Behaviour With Technology

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Sedentary Behaviour Through Wearable Technology and Education

Conditions
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Fatigue, Prostate Cancer, Breast Cancer, Sedentary Behaviour, Physical Activity

Intervention / Treatment
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* Other: Wearable Technology - Garmin Vivosmart
* Other: Online Educational Group
* Other: Wearable Technology - FitBit Alta
* Other: Wearable Technology - Polar Loop 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable Device Only<br>Participants will be allowed to choose one of three wearable devices (FitBit, Garmi or Polar), for the wearable technology intervention. Once the participant has chosen their wearable device they will be oriented to their chosen device, platform to obtain information from the device, as well as a guide with ideas for reducing sedentary behaviour. Participants will be asked to wear the devices every day during waking hours. | Other: Wearable Technology - Garmin Vivosmart<br>* Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.<br>Other: Wearable Technology - FitBit Alta<br>* Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.<br>Other: Wearable Technology - Polar Loop 2<br>* Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.<br>|
| Experimental: Online Educational Workshop Only<br>The Online Educational Group will be asked to participate in 6 online workshops that will occur during the 12-week intervention. Adobe connect software will be used to implement these workshops which allows for interaction between participants and leader. Workshops will focus on specific aspects related to reducing sedentary behaviours and increasing PA time. Each workshop will be developed by study coordinator/author (MO) and constructed using Social Cognitive Theory (SCT), ensuring the themes such as self-efficacy, self-control and reinforcements are within each topic. EDU topics will include motivation, goal setting, and activities and ways to reduce sedentary behaviour. | Other: Online Educational Group<br>* A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour<br>|
| Experimental: Wearable Device+Online Edu Workshop<br>Both the wearable technology intervention and Online Educational Group intervention simultaneously. | Other: Wearable Technology - Garmin Vivosmart<br>* Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.<br>Other: Online Educational Group<br>* A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour<br>Other: Wearable Technology - FitBit Alta<br>* Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.<br>Other: Wearable Technology - Polar Loop 2<br>* Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.<br>|
| No Intervention: Control Group<br>Participants in this group will receive usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | At baseline we will evaluate the recruitment rate of participants for the feasibility of this trial and reasons for declining to participate | Baseline | 
| Retention rate | 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. | 3 month assessment (Post-Intervention) | 
| Adherence | Adherence will be measured for participants attendance throughout the intervention. | 3 month assessment (Post-Intervention) | 
| WEAR device preference | This will be measured through the number of participants that choose each of the three devices. | 3 month assessment (Post-Intervention) | 
| Acceptability | Acceptability will be measured through the end of study questionnaire at the follow-up assessment | 6 months assessment (follow-up) | 
| Outcome measures captured | This will be measured through review and analysis of data obatined for completeness | 6 month assessment (follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-Related Fatigue | Assessed with Functional Assessment of Cancer Therapy - Fatigue (FACT-F) | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | 
| Sedentary Behaviour | Assessed through accelerometry and Sit-Q 7 Day questionnaire | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | 
| Quality of Life | Assessed with Functional Assessment of Cancer Therapy - General (FACT-G) | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | 
| Depression | Assessed with Patient Health Questionnaire - 9 (PHQ-9) | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) | 
| Understand attitudes towards using wearable technology | Assessed through semi-structured interviews | Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up) |