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Trial record 1 of 1 for:    NCT03321149
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Reducing Sedentary Behavior Among Prostate Cancer Survivors on Androgen Deprivation Therapy (RiseTx)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03321149
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : October 25, 2017
University of Toronto
Toronto Sunnybrook Regional Cancer Centre
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Neoplasm Cancer Sedentary Lifestyle Other: RiseTx Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: RiseTx: Testing the Feasibility of a Web Application for Reducing Sedentary Behavior Among Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
Actual Study Start Date : July 1, 2015
Actual Primary Completion Date : October 1, 2016
Actual Study Completion Date : October 1, 2016

Arm Intervention/treatment
Experimental: RiseTx
Participants were given access to the RiseTx application and an activity monitor to participate in the five phase intervention.
Other: RiseTx
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 Measures :
  1. Feasibility measures [ Time Frame: 12 weeks ]
    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 :
  1. Physical Activity (PA) [ Time Frame: Baseline, 12 Weeks, 24 week follow-up ]
    PA was measured by ActiGraph Model GT3X accelerometers

  2. Step counts [ Time Frame: Baseline and 12 Weeks ]
    Weekly step counts were collected using the Jawbone UP24.

  3. Sedentary Behavior (SED) [ Time Frame: Baseline, 12 Weeks, 24 week follow-up ]
    Volume of SED was measured by ActiGraph Model GT3X accelerometers.

  4. Quality of life [ Time Frame: Baseline, 12 Weeks, 24 week follow-up ]
    Quality of life was assessed by the validated Functional Assessment of Cancer Therapy-General (FACT-G).

  5. Cancer-specific quality of life [ Time Frame: Baseline, 12 Weeks, 24 week follow-up ]
    FACT-Prostate contains 12 questions that assess the most important targeted symptoms and concerns for participants.

Other Outcome Measures:
  1. Feasibility measures [ Time Frame: Baseline, 12 Weeks, 24 week follow-up ]
    Measurement completion was assessed by evaluating whether ≥75% of participants completed baseline, 12-weeks, and 24-week follow-up measures

  2. Feasibility measures [ Time Frame: 12 Weeks ]
    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)

  3. Feasibility measures [ Time Frame: Baseline, 12 Weeks, and 24 week follow-up ]
    Attrition was assessed by evaluating whether there was a ≤20% drop-out rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Illinois at Urbana-Champaign Identifier: NCT03321149    
Other Study ID Numbers: IRB2017
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Illinois at Urbana-Champaign:
Web-based intervention
Sedentary behavior
Lifestyle intervention
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases