FatigueNCT02911649
Reducing Sedentary Behaviour With Technology
A study testing Wearable Technology - Garmin Vivosmart, Online Educational Group and Wearable Technology - FitBit Alta in people with Fatigue and Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Fatigue, Prostate Cancer, Breast Cancer
- What is being tested?
- Wearable Technology - Garmin Vivosmart, Online Educational Group and Wearable Technology - FitBit Alta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Men who are or have received chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Sedentary Behaviour Through Wearable Technology and Education
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.
- Conditions
- Fatigue, Prostate Cancer, Breast Cancer, Sedentary Behaviour, Physical Activity
- Being tested
- Wearable Technology - Garmin Vivosmart, Online Educational Group, Wearable Technology - FitBit Alta, Wearable Technology - Polar Loop 2
- Medical subject headings
- Fatigue, Prostatic Neoplasms, Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Technology - Garmin VivosmartOther
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
Online Educational GroupOther
A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour
Wearable Technology - FitBit AltaOther
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 2Other
Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Device Only | Experimental | 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. Receives: Other: Wearable Technology - Garmin Vivosmart; Other: Wearable Technology - FitBit Alta; Other: Wearable Technology - Polar Loop 2 |
| Online Educational Workshop Only | Experimental | 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. Receives: Other: Online Educational Group |
| Wearable Device+Online Edu Workshop | Experimental | Both the wearable technology intervention and Online Educational Group intervention simultaneously. Receives: Other: Wearable Technology - Garmin Vivosmart; Other: Online Educational Group; Other: Wearable Technology - FitBit Alta; Other: Wearable Technology - Polar Loop 2 |
| Control Group | No intervention | Participants in this group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
At baseline we will evaluate the recruitment rate of participants for the feasibility of this trial and reasons for declining to participate
Measured: 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.
Measured: 3 month assessment (Post-Intervention)
Adherence
Adherence will be measured for participants attendance throughout the intervention.
Measured: 3 month assessment (Post-Intervention)
WEAR device preference
This will be measured through the number of participants that choose each of the three devices.
Measured: 3 month assessment (Post-Intervention)
Acceptability
Acceptability will be measured through the end of study questionnaire at the follow-up assessment
Measured: 6 months assessment (follow-up)
Outcome measures captured
This will be measured through review and analysis of data obatined for completeness
Measured: 6 month assessment (follow-up)
Secondary outcomes (5)
Cancer-Related Fatigue
Assessed with Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
Measured: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Sedentary Behaviour
Assessed through accelerometry and Sit-Q 7 Day questionnaire
Measured: 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)
Measured: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Depression
Assessed with Patient Health Questionnaire - 9 (PHQ-9)
Measured: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Understand attitudes towards using wearable technology
Assessed through semi-structured interviews
Measured: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2018
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Shabbir Alibhai, MD MSc, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911649
- Sponsor's protocol ID
- 16-5437
- Status last verified
- Apr 2021
- First submitted
- 8 Aug 2016
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sedentary Behaviour Through Wearable Technology and Education
- ClinicalTrials.gov ID
- NCT02911649
- Acronym / sponsor ID
- 16-5437
- Conditions
- Fatigue, Prostate Cancer, Breast Cancer, Sedentary Behaviour, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wearable Device Only | Experimental | Other: Wearable Technology - Garmin Vivosmart, Other: Wearable Technology - FitBit Alta, Other: Wearable Technology - Polar Loop 2Participants 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. |
| Online Educational Workshop Only | Experimental | Other: Online Educational GroupThe 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 | Experimental | Other: Wearable Technology - Garmin Vivosmart, Other: Online Educational Group, Other: Wearable Technology - FitBit Alta, Other: Wearable Technology - Polar Loop 2Both the wearable technology intervention and Online Educational Group intervention simultaneously. |
| Control Group | No intervention | –Participants in this group will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Men who are or have received chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Technology - Garmin VivosmartWearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels. | Other | Wearable Device Only, Wearable Device+Online Edu Workshop |
| Online Educational GroupA workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour | Other | Online Educational Workshop Only, Wearable Device+Online Edu Workshop |
| Wearable Technology - FitBit AltaWearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels. | Other | Wearable Device Only, Wearable Device+Online Edu Workshop |
| Wearable Technology - Polar Loop 2Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels. | Other | Wearable Device Only, Wearable Device+Online Edu Workshop |
Primary outcome
Recruitment rate
Time frame: Baseline
At baseline we will evaluate the recruitment rate of participants for the feasibility of this trial and reasons for declining to participate
Retention rate
Time frame: 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.
Adherence
Time frame: 3 month assessment (Post-Intervention)
Adherence will be measured for participants attendance throughout the intervention.
WEAR device preference
Time frame: 3 month assessment (Post-Intervention)
This will be measured through the number of participants that choose each of the three devices.
Acceptability
Time frame: 6 months assessment (follow-up)
Acceptability will be measured through the end of study questionnaire at the follow-up assessment
Outcome measures captured
Time frame: 6 month assessment (follow-up)
This will be measured through review and analysis of data obatined for completeness
5 secondary outcomes
Cancer-Related Fatigue
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Sedentary Behaviour
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Quality of Life
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Depression
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Understand attitudes towards using wearable technology
Time frame: Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shabbir Alibhai, MD MSc principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Technology - Garmin Vivosmart, Online Educational Group and Wearable Technology - FitBit Alta in people with Fatigue and Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.