Reducing Sedentary Behavior Among Prostate Cancer Survivors on Androgen Deprivation Therapy

NCT03321149 | Completed

• 1 other identifier: IRB2017
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer; Prostate Neoplasm; Cancer; Sedentary Lifestyle

Keywords

Web-based intervention; Sedentary behavior; Lifestyle intervention; Feasibility

Outcome Measures

Primary Outcomes (1)

• Feasibility measures

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

  12 weeks

Secondary Outcomes (5)

• Physical Activity (PA)

  Baseline, 12 Weeks, 24 week follow-up

• Step counts

  Baseline and 12 Weeks

• Sedentary Behavior (SED)

  Baseline, 12 Weeks, 24 week follow-up

• Quality of life

  Baseline, 12 Weeks, 24 week follow-up

• Cancer-specific quality of life

  Baseline, 12 Weeks, 24 week follow-up

Other Outcomes (3)

• Feasibility measures

  Baseline, 12 Weeks, 24 week follow-up

• Feasibility measures

  12 Weeks

• Feasibility measures

  Baseline, 12 Weeks, and 24 week follow-up

Study Arms (1)

RiseTx

EXPERIMENTAL

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

Other: RiseTx

Interventions

RiseTx OTHER

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.

RiseTx

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• University of Toronto: collaborator
• Toronto Sunnybrook Regional Cancer Centre: collaborator
• Princess Margaret Hospital, Canada: collaborator

Related Publications (8)

• 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.

  PMID: 23415624 BACKGROUND

• 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.

  PMID: 24139781 BACKGROUND

• 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.

  PMID: 20637084 BACKGROUND

• 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.

  PMID: 23425685 BACKGROUND

• 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.

  PMID: 8445433 BACKGROUND

• 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.

  PMID: 9426724 BACKGROUND

• 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.

  PMID: 21035130 BACKGROUND

• 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.

  PMID: 29880049 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Sedentary Behavior

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 25, 2017
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share