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Reducing Sedentary Behavior Among Prostate Cancer Survivors on Androgen Deprivation Therapy (RiseTx)

Primary Purpose

Prostate Cancer, Prostate Neoplasm, Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RiseTx
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Web-based intervention, Sedentary behavior, Lifestyle intervention, Feasibility

Eligibility Criteria

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

Inclusion Criteria:

  • ≥ 18 years of age
  • Men with localized or asymptomatic metastatic primary prostate cancer (Stage I-III)
  • Currently receiving ADT (continuous and/or intermittent) for at least 6 months
  • Active e-mail address to access the intervention website
  • Proficient in English
  • Physically inactive (< 150 minutes of moderate-intensity PA/week)
  • No uncontrolled co-morbidities
  • Medical clearance from the primary healthcare provider

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    RiseTx

    Arm Description

    Participants were given access to the RiseTx application and an activity monitor to participate in the five phase intervention.

    Outcomes

    Primary Outcome Measures

    Feasibility measures
    Intervention adherence was tracked through website analytics such as number of logins (≥ 3 visits by participants each week to the RiseTx platform)

    Secondary Outcome Measures

    Physical Activity (PA)
    PA was measured by ActiGraph Model GT3X accelerometers
    Step counts
    Weekly step counts were collected using the Jawbone UP24.
    Sedentary Behavior (SED)
    Volume of SED was measured by ActiGraph Model GT3X accelerometers.
    Quality of life
    Quality of life was assessed by the validated Functional Assessment of Cancer Therapy-General (FACT-G).
    Cancer-specific quality of life
    FACT-Prostate contains 12 questions that assess the most important targeted symptoms and concerns for participants.

    Full Information

    First Posted
    October 12, 2017
    Last Updated
    October 20, 2017
    Sponsor
    University of Illinois at Urbana-Champaign
    Collaborators
    University of Toronto, Toronto Sunnybrook Regional Cancer Centre, Princess Margaret Hospital, Canada
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03321149
    Brief Title
    Reducing Sedentary Behavior Among Prostate Cancer Survivors on Androgen Deprivation Therapy
    Acronym
    RiseTx
    Official Title
    RiseTx: Testing the Feasibility of a Web Application for Reducing Sedentary Behavior Among Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    October 1, 2016 (Actual)
    Study Completion Date
    October 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Illinois at Urbana-Champaign
    Collaborators
    University of Toronto, Toronto Sunnybrook Regional Cancer Centre, Princess Margaret Hospital, Canada

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The current study aimed to develop and assess an easy-to-use, highly accessible mobile and web-based application intervention to reduce sedentary behavior and increase physical activity in the hope of reducing the side effects of treatment and improving quality of life for the 13,000 or more prostate cancer survivors who are prescribed ADT each year in Canada. The study was conducted in two phases, where Phase one was focused on finding out about the attitudes and perceptions of sedentary behavior and the use of mobile applications among prostate cancer survivors using semi-structured interviews. Together with professional experts and a group of men who were diagnosed with prostate cancer, we developed RiseForTx - an application that is used on a smartphone or tablet to reduce time spent in, and to change patterns of, sedentary behaviour each day (Phase two). Part of the intervention was also focused on increasing daily steps to improve physical activity. We tested the intervention to examine (i) how the application works, (ii) if prostate cancer survivors like it and use it; and (iii) if sedentary behaviour and physical activity can reduce the impact of the side effects for treatment and improve quality of life among men on ADT.
    Detailed Description
    In the first 10 days following recruitment, participants met with the research coordinator and were provided with an accelerometer (GT3X) and completed self-report baseline measures. Provided along with the RiseTx application is the Jawbone, which is a wrist-worn device that can assess activity patterns throughout the day and provide sensory alerts to stand after prolonged sitting (i.e., ≥30 minutes of sedentary time). The intervention consisted of five phases following initial data collection, including a baseline phase (weeks 1-2) where participants self-monitored their typical leisure time PA (i.e., step counts) and were asked to 'sync' their Jawbone with the RiseTx application to view their daily progress and steps. This daily self-monitoring process continued over the remaining intervention period. Based on a previously tested ramped step count approach that focuses on increasing walking by an extra 1000 daily steps over a set period, participants attempted to increase daily steps by 1000 over the average of their baseline week. Phases I-III involved progressive release of self-regulatory strategies (e.g., action planning) on the application and targeted changes in both sitting time (and breaks in sitting time) and step counts. Phase I (weeks 3-4) focused on increasing low intensity, incidental movement, through the use of an alerting device, and the Jawbone (reminder to break SED). At this time, an additional +1000 daily step increment was set above baseline. Phase II (weeks 5-6) targeted shorter planned PA (of up to 10 mins) by having participants form action plans on the application for both reducing SED and increasing PA. An additional +1000 daily step increment was set above Phase I. Phase III (weeks 7-8) focused on promoting longer, moderate intensity PA (>10 min), where participants used the application to form coping plans for barriers to reducing sitting time or engaging in PA. An additional +1000 daily step increment was set above Phase II step target. A 4-week consolidation phase (Phase IV and V; weeks 9-12) followed, where participants received weekly reminders that encouraged them to continue to use the RiseTx application to practice combining the different self-regulatory strategies learned in Phases I-III. Following the intervention, there was a 12-week maintenance period (weeks 13-24) where participants no longer received weekly self-regulatory practice reminders, yet still had access to the application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer, Prostate Neoplasm, Cancer, Sedentary Lifestyle
    Keywords
    Web-based intervention, Sedentary behavior, Lifestyle intervention, Feasibility

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    RiseTx
    Arm Type
    Experimental
    Arm Description
    Participants were given access to the RiseTx application and an activity monitor to participate in the five phase intervention.
    Intervention Type
    Other
    Intervention Name(s)
    RiseTx
    Intervention Description
    Participants were given access to the RiseTx application, as well as given a Jawbone, a wrist-worn device that can assess activity patterns throughout the day and provide sensory alerts to stand after prolonged sitting (i.e., ≥30 minutes of sedentary time). The intervention consisted of five phases following initial data collection that comprised of self-regulatory strategies to reduce sitting time and self-monitoring of step counts.
    Primary Outcome Measure Information:
    Title
    Feasibility measures
    Description
    Intervention adherence was tracked through website analytics such as number of logins (≥ 3 visits by participants each week to the RiseTx platform)
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Physical Activity (PA)
    Description
    PA was measured by ActiGraph Model GT3X accelerometers
    Time Frame
    Baseline, 12 Weeks, 24 week follow-up
    Title
    Step counts
    Description
    Weekly step counts were collected using the Jawbone UP24.
    Time Frame
    Baseline and 12 Weeks
    Title
    Sedentary Behavior (SED)
    Description
    Volume of SED was measured by ActiGraph Model GT3X accelerometers.
    Time Frame
    Baseline, 12 Weeks, 24 week follow-up
    Title
    Quality of life
    Description
    Quality of life was assessed by the validated Functional Assessment of Cancer Therapy-General (FACT-G).
    Time Frame
    Baseline, 12 Weeks, 24 week follow-up
    Title
    Cancer-specific quality of life
    Description
    FACT-Prostate contains 12 questions that assess the most important targeted symptoms and concerns for participants.
    Time Frame
    Baseline, 12 Weeks, 24 week follow-up
    Other Pre-specified Outcome Measures:
    Title
    Feasibility measures
    Description
    Measurement completion was assessed by evaluating whether ≥75% of participants completed baseline, 12-weeks, and 24-week follow-up measures
    Time Frame
    Baseline, 12 Weeks, 24 week follow-up
    Title
    Feasibility measures
    Description
    Acceptability was measured through an intervention satisfaction survey completed at post-intervention assessing perceptions and overall impressions of the RiseTx intervention (>75% rate their participation as satisfactory or very satisfactory)
    Time Frame
    12 Weeks
    Title
    Feasibility measures
    Description
    Attrition was assessed by evaluating whether there was a ≤20% drop-out rate
    Time Frame
    Baseline, 12 Weeks, and 24 week follow-up

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ≥ 18 years of age Men with localized or asymptomatic metastatic primary prostate cancer (Stage I-III) Currently receiving ADT (continuous and/or intermittent) for at least 6 months Active e-mail address to access the intervention website Proficient in English Physically inactive (< 150 minutes of moderate-intensity PA/week) No uncontrolled co-morbidities Medical clearance from the primary healthcare provider

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
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    23415624
    Citation
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    Mitchell MS, Goodman JM, Alter DA, John LK, Oh PI, Pakosh MT, Faulkner GE. Financial incentives for exercise adherence in adults: systematic review and meta-analysis. Am J Prev Med. 2013 Nov;45(5):658-67. doi: 10.1016/j.amepre.2013.06.017.
    Results Reference
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    PubMed Identifier
    20637084
    Citation
    Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67.
    Results Reference
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    PubMed Identifier
    23425685
    Citation
    Kuijpers W, Groen WG, Aaronson NK, van Harten WH. A systematic review of web-based interventions for patient empowerment and physical activity in chronic diseases: relevance for cancer survivors. J Med Internet Res. 2013 Feb 20;15(2):e37. doi: 10.2196/jmir.2281.
    Results Reference
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    PubMed Identifier
    8445433
    Citation
    Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
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    PubMed Identifier
    9426724
    Citation
    Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997 Dec;50(6):920-8. doi: 10.1016/S0090-4295(97)00459-7.
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    Citation
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    PubMed Identifier
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    Citation
    Trinh L, Arbour-Nicitopoulos KP, Sabiston CM, Berry SR, Loblaw A, Alibhai SMH, Jones JM, Faulkner GE. RiseTx: testing the feasibility of a web application for reducing sedentary behavior among prostate cancer survivors receiving androgen deprivation therapy. Int J Behav Nutr Phys Act. 2018 Jun 7;15(1):49. doi: 10.1186/s12966-018-0686-0. Erratum In: Int J Behav Nutr Phys Act. 2018 Dec 4;15(1):124.
    Results Reference
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    Reducing Sedentary Behavior Among Prostate Cancer Survivors on Androgen Deprivation Therapy

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