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Completed

NCT Number: NCT02911649

Reducing Sedentary Behaviour With Technology

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.

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Key information

Conditions

Fatigue Behavior Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Physical Activity Prostate Cancer Prostatic Diseases Prostatic Neoplasms Sedentary Behaviour Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Online Educational Group

Other

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

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 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.

Primary outcomes

  1. 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

  2. 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.

  3. Adherence

    Time frame: 3 month assessment (Post-Intervention)

    Adherence will be measured for participants attendance throughout the intervention.

  4. 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.

  5. Acceptability

    Time frame: 6 months assessment (follow-up)

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

  6. Outcome measures captured

    Time frame: 6 month assessment (follow-up)

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

Secondary outcomes

  1. Cancer-Related Fatigue

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

    Assessed with Functional Assessment of Cancer Therapy - Fatigue (FACT-F)

  2. Sedentary Behaviour

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

    Assessed through accelerometry and Sit-Q 7 Day questionnaire

  3. Quality of Life

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

    Assessed with Functional Assessment of Cancer Therapy - General (FACT-G)

  4. Depression

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

    Assessed with Patient Health Questionnaire - 9 (PHQ-9)

  5. Understand attitudes towards using wearable technology

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

    Assessed through semi-structured interviews

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • University of Toronto

Registry information

Official study title

Reducing Sedentary Behaviour Through Wearable Technology and Education

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Sep 22, 2016
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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