Reducing Sedentary Behaviour With Technology

NCT02911649 | Completed

• 1 other identifier: 16-5437
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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of the intervention and follow-up assessment, we will measure retention rate through number of participants who have withdrawn from the study.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)

• Adherence

  Adherence will be measured for participants attendance throughout the intervention.

  3 month assessment (Post-Intervention)

• WEAR device preference

  This will be measured through the number of participants that choose each of the three devices.

  3 month assessment (Post-Intervention)

• Acceptability

  Acceptability will be measured through the end of study questionnaire at the follow-up assessment

  6 months assessment (follow-up)

• Outcome measures captured

  This will be measured through review and analysis of data obatined for completeness

  6 month assessment (follow-up)

Secondary Outcomes (5)

• Cancer-Related Fatigue

  Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)

• Sedentary Behaviour

  Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)

• Quality of Life

  Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)

• Depression

  Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)

• Understand attitudes towards using wearable technology

  Baseline, 3 month assessment(post-intervention), 6 month assessment (3 month Follow up)

Study Arms (4)

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.

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.

Other: Online Educational Group

Wearable Device+Online Edu Workshop

EXPERIMENTAL

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

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

Interventions

Wearable Technology - Garmin Vivosmart OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

Wearable Device Only; Wearable Device+Online Edu Workshop

Online Educational Group OTHER

A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour

Online Educational Workshop Only; Wearable Device+Online Edu Workshop

Wearable Technology - FitBit Alta OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

Wearable Device Only; Wearable Device+Online Edu Workshop

Wearable Technology - Polar Loop 2 OTHER

Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.

Wearable Device Only; Wearable Device+Online Edu Workshop

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Men who are or have received chemotherapy

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Fatigue; Prostatic Neoplasms; Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Shabbir Alibhai, MD MSc

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: September 22, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)