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
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
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
NCT ID
NCT03321149
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
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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Citation
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Results Reference
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Citation
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Citation
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8445433
Citation
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Citation
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Results Reference
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Reducing Sedentary Behavior Among Prostate Cancer Survivors on Androgen Deprivation Therapy
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