- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03321149
Reducing Sedentary Behavior Among Prostate Cancer Survivors on Androgen Deprivation Therapy (RiseTx)
20. Oktober 2017 aktualisiert von: University of Illinois at Urbana-Champaign
RiseTx: Testing the Feasibility of a Web Application for Reducing Sedentary Behavior Among Prostate Cancer Survivors Receiving Androgen Deprivation Therapy
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
46
Phase
- Unzutreffend
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Männlich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: RiseTx
Participants were given access to the RiseTx application and an activity monitor to participate in the five phase intervention.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility measures
Zeitfenster: 12 weeks
|
Intervention adherence was tracked through website analytics such as number of logins (≥ 3 visits by participants each week to the RiseTx platform)
|
12 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Physical Activity (PA)
Zeitfenster: Baseline, 12 Weeks, 24 week follow-up
|
PA was measured by ActiGraph Model GT3X accelerometers
|
Baseline, 12 Weeks, 24 week follow-up
|
|
Step counts
Zeitfenster: Baseline and 12 Weeks
|
Weekly step counts were collected using the Jawbone UP24.
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Baseline and 12 Weeks
|
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Sedentary Behavior (SED)
Zeitfenster: Baseline, 12 Weeks, 24 week follow-up
|
Volume of SED was measured by ActiGraph Model GT3X accelerometers.
|
Baseline, 12 Weeks, 24 week follow-up
|
|
Quality of life
Zeitfenster: Baseline, 12 Weeks, 24 week follow-up
|
Quality of life was assessed by the validated Functional Assessment of Cancer Therapy-General (FACT-G).
|
Baseline, 12 Weeks, 24 week follow-up
|
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Cancer-specific quality of life
Zeitfenster: Baseline, 12 Weeks, 24 week follow-up
|
FACT-Prostate contains 12 questions that assess the most important targeted symptoms and concerns for participants.
|
Baseline, 12 Weeks, 24 week follow-up
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility measures
Zeitfenster: 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
|
Baseline, 12 Weeks, 24 week follow-up
|
|
Feasibility measures
Zeitfenster: 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)
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12 Weeks
|
|
Feasibility measures
Zeitfenster: Baseline, 12 Weeks, and 24 week follow-up
|
Attrition was assessed by evaluating whether there was a ≤20% drop-out rate
|
Baseline, 12 Weeks, and 24 week follow-up
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Leon AC, Davis LL, Kraemer HC. The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
- 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.
- 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.
- Gilson ND, Faulkner G, Murphy MH, Meyer MR, Washington T, Ryde GC, Arbour-Nicitopoulos KP, Dillon KA. Walk@Work: An automated intervention to increase walking in university employees not achieving 10,000 daily steps. Prev Med. 2013 May;56(5):283-7. doi: 10.1016/j.ypmed.2013.01.022. Epub 2013 Feb 13.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Juli 2015
Primärer Abschluss (Tatsächlich)
1. Oktober 2016
Studienabschluss (Tatsächlich)
1. Oktober 2016
Studienanmeldedaten
Zuerst eingereicht
12. Oktober 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Oktober 2017
Zuerst gepostet (Tatsächlich)
25. Oktober 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
25. Oktober 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
20. Oktober 2017
Zuletzt verifiziert
1. Oktober 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB2017
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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