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Reducing Sedentary Behaviour With Technology

Primary Purpose

Fatigue, Prostate Cancer, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Wearable Technology - Garmin Vivosmart
Online Educational Group
Wearable Technology - FitBit Alta
Wearable Technology - Polar Loop 2
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Wearable Device Only

Online Educational Workshop Only

Wearable Device+Online Edu Workshop

Control Group

Arm Description

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.

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.

Both the wearable technology intervention and Online Educational Group intervention simultaneously.

Participants in this group will receive usual care

Outcomes

Primary Outcome Measures

Recruitment rate
At baseline we will evaluate the recruitment rate of participants for the feasibility of this trial and reasons for declining to participate
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.
Adherence
Adherence will be measured for participants attendance throughout the intervention.
WEAR device preference
This will be measured through the number of participants that choose each of the three devices.
Acceptability
Acceptability will be measured through the end of study questionnaire at the follow-up assessment
Outcome measures captured
This will be measured through review and analysis of data obatined for completeness

Secondary Outcome Measures

Cancer-Related Fatigue
Assessed with Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Sedentary Behaviour
Assessed through accelerometry and Sit-Q 7 Day questionnaire
Quality of Life
Assessed with Functional Assessment of Cancer Therapy - General (FACT-G)
Depression
Assessed with Patient Health Questionnaire - 9 (PHQ-9)
Understand attitudes towards using wearable technology
Assessed through semi-structured interviews

Full Information

First Posted
August 8, 2016
Last Updated
April 11, 2021
Sponsor
University Health Network, Toronto
Collaborators
University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02911649
Brief Title
Reducing Sedentary Behaviour With Technology
Official Title
Reducing Sedentary Behaviour Through Wearable Technology and Education
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
University of Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Prostate Cancer, Breast Cancer, Sedentary Behaviour, Physical Activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wearable Device Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Online Educational Workshop Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Wearable Device+Online Edu Workshop
Arm Type
Experimental
Arm Description
Both the wearable technology intervention and Online Educational Group intervention simultaneously.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants in this group will receive usual care
Intervention Type
Other
Intervention Name(s)
Wearable Technology - Garmin Vivosmart
Intervention Description
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Intervention Type
Other
Intervention Name(s)
Online Educational Group
Intervention Description
A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour
Intervention Type
Other
Intervention Name(s)
Wearable Technology - FitBit Alta
Intervention Description
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Intervention Type
Other
Intervention Name(s)
Wearable Technology - Polar Loop 2
Intervention Description
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
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
Title
Retention rate
Description
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)
Title
Adherence
Description
Adherence will be measured for participants attendance throughout the intervention.
Time Frame
3 month assessment (Post-Intervention)
Title
WEAR device preference
Description
This will be measured through the number of participants that choose each of the three devices.
Time Frame
3 month assessment (Post-Intervention)
Title
Acceptability
Description
Acceptability will be measured through the end of study questionnaire at the follow-up assessment
Time Frame
6 months assessment (follow-up)
Title
Outcome measures captured
Description
This will be measured through review and analysis of data obatined for completeness
Time Frame
6 month assessment (follow-up)
Secondary Outcome Measure Information:
Title
Cancer-Related Fatigue
Description
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)
Title
Sedentary Behaviour
Description
Assessed through accelerometry and Sit-Q 7 Day questionnaire
Time Frame
Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Title
Quality of Life
Description
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)
Title
Depression
Description
Assessed with Patient Health Questionnaire - 9 (PHQ-9)
Time Frame
Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Title
Understand attitudes towards using wearable technology
Description
Assessed through semi-structured interviews
Time Frame
Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shabbir Alibhai, MD MSc
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Sedentary Behaviour With Technology

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