Reducing Sedentary Behaviour With Technology

Breast Cancer Clinical Trial

Official title:

Reducing Sedentary Behaviour Through Wearable Technology and Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911649
• Other study ID #: 16-5437
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: April 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Fatigue
• Physical Activity
• Prostate Cancer
• Sedentary Behaviour

Intervention

Other:
• Wearable Technology - Garmin Vivosmart
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
• Online Educational Group
A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour
• Wearable Technology - FitBit Alta
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
• Wearable 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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	Adherence	Adherence will be measured for participants attendance throughout the intervention.	3 month assessment (Post-Intervention)
Primary	WEAR device preference	This will be measured through the number of participants that choose each of the three devices.	3 month assessment (Post-Intervention)
Primary	Acceptability	Acceptability will be measured through the end of study questionnaire at the follow-up assessment	6 months assessment (follow-up)
Primary	Outcome measures captured	This will be measured through review and analysis of data obatined for completeness	6 month assessment (follow-up)
Secondary	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)
Secondary	Sedentary Behaviour	Assessed through accelerometry and Sit-Q 7 Day questionnaire	Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Secondary	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)
Secondary	Depression	Assessed with Patient Health Questionnaire - 9 (PHQ-9)	Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Secondary	Understand attitudes towards using wearable technology	Assessed through semi-structured interviews	Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)