Reducing Sedentary Behaviour With Technology

Not Applicable

Completed

• Conditions: Prostate Cancer; Breast Cancer; Sedentary Behaviour; Fatigue; Physical Activity
• Interventions: Other: Wearable Technology - Garmin Vivosmart; Other: Wearable Technology - FitBit Alta; Other: Online Educational Group; Other: Wearable Technology - Polar Loop 2

• Registration Number: NCT02911649
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-08
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-22
• Primary Completion: 2018-03
• Study Completion: 2019-03
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-11
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wearable Device Only	Wearable Technology - FitBit Alta	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.
Wearable Device Only	Wearable Technology - Garmin Vivosmart	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.
Wearable Device Only	Wearable Technology - Polar Loop 2	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.
Wearable Device+Online Edu Workshop	Online Educational Group	Both the wearable technology intervention and Online Educational Group intervention simultaneously.
Online Educational Workshop Only	Online Educational Group	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.
Wearable Device+Online Edu Workshop	Wearable Technology - Garmin Vivosmart	Both the wearable technology intervention and Online Educational Group intervention simultaneously.
Wearable Device+Online Edu Workshop	Wearable Technology - FitBit Alta	Both the wearable technology intervention and Online Educational Group intervention simultaneously.
Wearable Device+Online Edu Workshop	Wearable Technology - Polar Loop 2	Both the wearable technology intervention and Online Educational Group intervention simultaneously.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada