Clinical trial NCT02911649: Reducing Sedentary Behaviour With Technology
Official title: Reducing Sedentary Behaviour Through Wearable Technology and Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Prostate Cancer
Breast Cancer
Sedentary Behaviour
Physical Activity
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2016-09-22
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Baseline
measure: Retention rate
timeFrame: 3 month assessment (Post-Intervention)
measure: Adherence
timeFrame: 3 month assessment (Post-Intervention)
measure: WEAR device preference
timeFrame: 3 month assessment (Post-Intervention)
measure: Acceptability
timeFrame: 6 months assessment (follow-up)
measure: Outcome measures captured
timeFrame: 6 month assessment (follow-up)
Secondary outcomes:
measure: Cancer-Related Fatigue
timeFrame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
measure: Sedentary Behaviour
timeFrame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
measure: Quality of Life
timeFrame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
measure: Depression
timeFrame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
measure: Understand attitudes towards using wearable technology
timeFrame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Shabbir Alibhai, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: