An interventional study of Wearable Technology - Garmin Vivosmart and Online Educational Group in Fatigue, Prostate Cancer and Breast Cancer, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-13.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Supportive care
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.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's enrollment of 28 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Wearable Technology - FitBit Alta · Other: Wearable Technology - Polar Loop 2
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
Both the wearable technology intervention and Online Educational Group intervention simultaneously.
Other: Wearable Technology - Garmin Vivosmart · Other: Online Educational Group · Other: Wearable Technology - FitBit Alta · Other: Wearable Technology - Polar Loop 2
Participants in this group will receive usual care
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Recruitment rate
At baseline we will evaluate the recruitment rate of participants for the feasibility of this trial and reasons for declining to participate
Time frame: 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.
Time frame: 3 month assessment (Post-Intervention)
Adherence
Adherence will be measured for participants attendance throughout the intervention.
Time frame: 3 month assessment (Post-Intervention)
WEAR device preference
This will be measured through the number of participants that choose each of the three devices.
Time frame: 3 month assessment (Post-Intervention)
Acceptability
Acceptability will be measured through the end of study questionnaire at the follow-up assessment
Time frame: 6 months assessment (follow-up)
Outcome measures captured
This will be measured through review and analysis of data obatined for completeness
Time frame: 6 month assessment (follow-up)
Cancer-Related Fatigue
Assessed with Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Sedentary Behaviour
Assessed through accelerometry and Sit-Q 7 Day questionnaire
Time frame: 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)
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Depression
Assessed with Patient Health Questionnaire - 9 (PHQ-9)
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Understand attitudes towards using wearable technology
Assessed through semi-structured interviews
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Health Network, Toronto