Sedentary LifestyleNCT03740035
Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients
An observational study of Sedentary Lifestyle, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The overall objective of this study is to adapt and refine an existing eHealth (web-application/web-app/app) platform designed to promote spontaneous movement (reducing sedentary behavior) among older adults, to men with prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Sedentary Lifestyle
- What is being tested?
- eHealth for Sedentary Behavior
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 18 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prostate cancer patients currently receiving treatment
Who may be able to join
- Histologically confirmed prostate cancer.
- Currently (in last 2-years) receiving care for prostate cancer at WFBMC.
- Currently owns a smartphone or a tablet computer (iOS and major brand Android devices not including eReaders).
- English-speaking.
Who cannot join
- Unable to provide informed consent (e.g., delirium).
- Unable to ambulate safely (fall risk).
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
The overall objective of this study is to adapt and refine an existing eHealth (web-application/web-app/app) platform designed to promote spontaneous movement (reducing sedentary behavior) among older adults, to men with prostate cancer.
Read the detailed description
Primary treatments for prostate cancer (PCa) accelerate aging-related changes in body composition and declines in physical function and quality of life ; the median age at PCa diagnosis is 66 years and approximately 64% of PCa survivors are > 70 years. The negative side effects of treatments are pronounced in older, sedentary, overweight or obese men with existing comorbidities. The concomitant loss of skeletal muscle mass, increased deposition of adipose tissue and loss of bone mineral density leads to fractures, cancer-related fatigue, frailty, compromised physical functioning, disability and loss of independence as well as anxiety and depression. Regular physical activity reduces morbidity, improves survival and can buffer PCa patients against the negative side-effects of treatment, yet less than 20% are meeting recommended guidelines-and most spend up to 70% of their time each day in sedentary behavior. Targeting a reduction in sedentary behavior by promoting regular spontaneous movement in conjunction with regular resistance training may be an effective approach for PCa patients who are likely to be fatigued and functionally impaired. Traditional theory-based exercise interventions have shown preliminary efficacy for promoting short-term exercise, but can be improved for longer-term efficacy. Traditional exercise interventions are generally not individually tailored, and therefore cannot incorporate behavioral theory to re-engage participants when lapses in self-regulation occur. eHealth technologies can enhance traditional theory-based exercise interventions. The study team hypothesizes that an eHealth delivered intervention can effectively facilitate the development and maintenance of self-regulatory skills that are critical to sustaining long-term behavior change.
- Conditions
- Sedentary Lifestyle
- Being tested
- eHealth for Sedentary Behavior
- Keywords
- Prostate Cancer, eHealth, movement
- Medical subject headings
- Sedentary Behavior, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth for Sedentary BehaviorDevice
Prostate cancer patients will be testing the usability and acceptability of the eHealth web app for sedentary behavior
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer Patients | Prostate cancer patients that who have been actively receiving care through Wake Forest Baptist Comprehensive Cancer Center and/or satellite clinics over the past two-year period will be using an eHealth for Sedentary Behavior. Receives: Device: eHealth for Sedentary Behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the design features and functionality of the web-app
Participants will be given qualitative interviews on the functionality of the web-app. A thematic content analysis (TCA) for the evaluation of Think-Aloud and interview data will be used. Transcripts will be imported into ATLAS.ti software (Version 8, Berlin, Germany) and reviewed by the study team using an iterative approach.
Measured: 45 minutes
System Usability Scale
Participants will answer 10, 5-point Likert-type questions to collect perceptions of the usability of the web-app. Total score 10-50, Higher scores denote better outcomes
Measured: 30 minutes
Participant reflection on web-app features
Descriptive statistics to report on the open-ended qualitative reflections on app features will be coded using thematic content anaylsis as audio recordings.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start13 Aug 2018
- Primary completion17 Oct 2018
- Study completion18 Jun 2019
Why it stopped: Pl left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Sedentary LifestyleStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rhonda L Bitting, MD, Principal investigator, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740035
- Sponsor's protocol ID
- IRB00051239
- Other IDs
- CCCWFU 04118, P30CA012197
- Status last verified
- Mar 2022
- First submitted
- 9 Nov 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271-89. doi: 10.3322/caac.21349. Epub 2016 Jun 2.
PubMed 27253694Chambers SK, Ng SK, Baade P, Aitken JF, Hyde MK, Wittert G, Frydenberg M, Dunn J. Trajectories of quality of life, life satisfaction, and psychological adjustment after prostate cancer. Psychooncology. 2017 Oct;26(10):1576-1585. doi: 10.1002/pon.4342. Epub 2017 Jan 11.
PubMed 27943512Cheung AS, Zajac JD, Grossmann M. Muscle and bone effects of androgen deprivation therapy: current and emerging therapies. Endocr Relat Cancer. 2014 Oct;21(5):R371-94. doi: 10.1530/ERC-14-0172. Epub 2014 Jul 23.
PubMed 25056176Alibhai SM, Duong-Hua M, Cheung AM, Sutradhar R, Warde P, Fleshner NE, Paszat L. Fracture types and risk factors in men with prostate cancer on androgen deprivation therapy: a matched cohort study of 19,079 men. J Urol. 2010 Sep;184(3):918-23. doi: 10.1016/j.juro.2010.04.068.
PubMed 20643458Pirl WF, Greer JA, Goode M, Smith MR. Prospective study of depression and fatigue in men with advanced prostate cancer receiving hormone therapy. Psychooncology. 2008 Feb;17(2):148-53. doi: 10.1002/pon.1206.
PubMed 17443645Bylow K, Dale W, Mustian K, Stadler WM, Rodin M, Hall W, Lachs M, Mohile SG. Falls and physical performance deficits in older patients with prostate cancer undergoing androgen deprivation therapy. Urology. 2008 Aug;72(2):422-7. doi: 10.1016/j.urology.2008.03.032. Epub 2008 Jun 17.
PubMed 18561991Dinh KT, Reznor G, Muralidhar V, Mahal BA, Nezolosky MD, Choueiri TK, Hoffman KE, Hu JC, Sweeney CJ, Trinh QD, Nguyen PL. Association of Androgen Deprivation Therapy With Depression in Localized Prostate Cancer. J Clin Oncol. 2016 Jun 1;34(16):1905-12. doi: 10.1200/JCO.2015.64.1969. Epub 2016 Apr 11.
PubMed 27069075Bhatia N, Santos M, Jones LW, Beckman JA, Penson DF, Morgans AK, Moslehi J. Cardiovascular Effects of Androgen Deprivation Therapy for the Treatment of Prostate Cancer: ABCDE Steps to Reduce Cardiovascular Disease in Patients With Prostate Cancer. Circulation. 2016 Feb 2;133(5):537-41. doi: 10.1161/CIRCULATIONAHA.115.012519. No abstract available.
PubMed 26831435Levine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010 Feb 16;121(6):833-40. doi: 10.1161/CIRCULATIONAHA.109.192695. Epub 2010 Feb 1. No abstract available.
PubMed 20124128Richman EL, Kenfield SA, Stampfer MJ, Paciorek A, Carroll PR, Chan JM. Physical activity after diagnosis and risk of prostate cancer progression: data from the cancer of the prostate strategic urologic research endeavor. Cancer Res. 2011 Jun 1;71(11):3889-95. doi: 10.1158/0008-5472.CAN-10-3932. Epub 2011 May 24.
PubMed 21610110Kenfield SA, Stampfer MJ, Giovannucci E, Chan JM. Physical activity and survival after prostate cancer diagnosis in the health professionals follow-up study. J Clin Oncol. 2011 Feb 20;29(6):726-32. doi: 10.1200/JCO.2010.31.5226. Epub 2011 Jan 4.
PubMed 21205749Thorsen L, Courneya KS, Stevinson C, Fossa SD. A systematic review of physical activity in prostate cancer survivors: outcomes, prevalence, and determinants. Support Care Cancer. 2008 Sep;16(9):987-97. doi: 10.1007/s00520-008-0411-7. Epub 2008 Feb 15.
PubMed 18274783Galvao DA, Newton RU, Gardiner RA, Girgis A, Lepore SJ, Stiller A, Occhipinti S, Chambers SK. Compliance to exercise-oncology guidelines in prostate cancer survivors and associations with psychological distress, unmet supportive care needs, and quality of life. Psychooncology. 2015 Oct;24(10):1241-1249. doi: 10.1002/pon.3882. Epub 2015 Jun 18.
PubMed 26087455Blanchard CM, Courneya KS, Stein K; American Cancer Society's SCS-II. Cancer survivors' adherence to lifestyle behavior recommendations and associations with health-related quality of life: results from the American Cancer Society's SCS-II. J Clin Oncol. 2008 May 1;26(13):2198-204. doi: 10.1200/JCO.2007.14.6217.
PubMed 18445845Tarasenko Y, Chen C, Schoenberg N. Self-Reported Physical Activity Levels of Older Cancer Survivors: Results from the 2014 National Health Interview Survey. J Am Geriatr Soc. 2017 Feb;65(2):e39-e44. doi: 10.1111/jgs.14589. Epub 2016 Dec 9.
PubMed 27943255
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03740035
- Acronym / sponsor ID
- IRB00051239
- Conditions
- Sedentary Lifestyle
- Keywords
- Prostate Cancer, eHealth, movement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Pl left institution
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 17 Oct 2018 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to adapt and refine an existing eHealth (web-application/web-app/app) platform designed to promote spontaneous movement (reducing sedentary behavior) among older adults, to men with prostate cancer.
Detailed description
Primary treatments for prostate cancer (PCa) accelerate aging-related changes in body composition and declines in physical function and quality of life ; the median age at PCa diagnosis is 66 years and approximately 64% of PCa survivors are > 70 years. The negative side effects of treatments are pronounced in older, sedentary, overweight or obese men with existing comorbidities. The concomitant loss of skeletal muscle mass, increased deposition of adipose tissue and loss of bone mineral density leads to fractures, cancer-related fatigue, frailty, compromised physical functioning, disability and loss of independence as well as anxiety and depression. Regular physical activity reduces morbidity, improves survival and can buffer PCa patients against the negative side-effects of treatment, yet less than 20% are meeting recommended guidelines-and most spend up to 70% of their time each day in sedentary behavior. Targeting a reduction in sedentary behavior by promoting regular spontaneous movement in conjunction with regular resistance training may be an effective approach for PCa patients who are likely to be fatigued and functionally impaired. Traditional theory-based exercise interventions have shown preliminary efficacy for promoting short-term exercise, but can be improved for longer-term efficacy. Traditional exercise interventions are generally not individually tailored, and therefore cannot incorporate behavioral theory to re-engage participants when lapses in self-regulation occur. eHealth technologies can enhance traditional theory-based exercise interventions. The study team hypothesizes that an eHealth delivered intervention can effectively facilitate the development and maintenance of self-regulatory skills that are critical to sustaining long-term behavior change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Patients | – | Device: eHealth for Sedentary BehaviorProstate cancer patients that who have been actively receiving care through Wake Forest Baptist Comprehensive Cancer Center and/or satellite clinics over the past two-year period will be using an eHealth for Sedentary Behavior. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prostate cancer patients currently receiving treatment
Key inclusion criteria (4 listed)
- Histologically confirmed prostate cancer.
- Currently (in last 2-years) receiving care for prostate cancer at WFBMC.
- Currently owns a smartphone or a tablet computer (iOS and major brand Android devices not including eReaders).
- English-speaking.
Key exclusion criteria (2 listed)
- Unable to provide informed consent (e.g., delirium).
- Unable to ambulate safely (fall risk).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth for Sedentary BehaviorProstate cancer patients will be testing the usability and acceptability of the eHealth web app for sedentary behavior | Device | Prostate Cancer Patients |
Primary outcome
Assessment of the design features and functionality of the web-app
Time frame: 45 minutes
Participants will be given qualitative interviews on the functionality of the web-app. A thematic content analysis (TCA) for the evaluation of Think-Aloud and interview data will be used. Transcripts will be imported into ATLAS.ti software (Version 8, Berlin, Germany) and reviewed by the study team using an iterative approach.
System Usability Scale
Time frame: 30 minutes
Participants will answer 10, 5-point Likert-type questions to collect perceptions of the usability of the web-app. Total score 10-50, Higher scores denote better outcomes
Participant reflection on web-app features
Time frame: 30 minutes
Descriptive statistics to report on the open-ended qualitative reflections on app features will be coded using thematic content anaylsis as audio recordings.
Results and safety
The study was stopped early (reason given: Pl left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 27253694Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271-89. doi: 10.3322/caac.21349. Epub 2016 Jun 2.
- Background: PubMed 27943512Chambers SK, Ng SK, Baade P, Aitken JF, Hyde MK, Wittert G, Frydenberg M, Dunn J. Trajectories of quality of life, life satisfaction, and psychological adjustment after prostate cancer. Psychooncology. 2017 Oct;26(10):1576-1585. doi: 10.1002/pon.4342. Epub 2017 Jan 11.
- Background: PubMed 25056176Cheung AS, Zajac JD, Grossmann M. Muscle and bone effects of androgen deprivation therapy: current and emerging therapies. Endocr Relat Cancer. 2014 Oct;21(5):R371-94. doi: 10.1530/ERC-14-0172. Epub 2014 Jul 23.
- Background: PubMed 20643458Alibhai SM, Duong-Hua M, Cheung AM, Sutradhar R, Warde P, Fleshner NE, Paszat L. Fracture types and risk factors in men with prostate cancer on androgen deprivation therapy: a matched cohort study of 19,079 men. J Urol. 2010 Sep;184(3):918-23. doi: 10.1016/j.juro.2010.04.068.
- Background: PubMed 17443645Pirl WF, Greer JA, Goode M, Smith MR. Prospective study of depression and fatigue in men with advanced prostate cancer receiving hormone therapy. Psychooncology. 2008 Feb;17(2):148-53. doi: 10.1002/pon.1206.
- Background: PubMed 18561991Bylow K, Dale W, Mustian K, Stadler WM, Rodin M, Hall W, Lachs M, Mohile SG. Falls and physical performance deficits in older patients with prostate cancer undergoing androgen deprivation therapy. Urology. 2008 Aug;72(2):422-7. doi: 10.1016/j.urology.2008.03.032. Epub 2008 Jun 17.
- Background: PubMed 27069075Dinh KT, Reznor G, Muralidhar V, Mahal BA, Nezolosky MD, Choueiri TK, Hoffman KE, Hu JC, Sweeney CJ, Trinh QD, Nguyen PL. Association of Androgen Deprivation Therapy With Depression in Localized Prostate Cancer. J Clin Oncol. 2016 Jun 1;34(16):1905-12. doi: 10.1200/JCO.2015.64.1969. Epub 2016 Apr 11.
- Background: PubMed 26831435Bhatia N, Santos M, Jones LW, Beckman JA, Penson DF, Morgans AK, Moslehi J. Cardiovascular Effects of Androgen Deprivation Therapy for the Treatment of Prostate Cancer: ABCDE Steps to Reduce Cardiovascular Disease in Patients With Prostate Cancer. Circulation. 2016 Feb 2;133(5):537-41. doi: 10.1161/CIRCULATIONAHA.115.012519. No abstract available.
- Background: PubMed 20124128Levine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010 Feb 16;121(6):833-40. doi: 10.1161/CIRCULATIONAHA.109.192695. Epub 2010 Feb 1. No abstract available.
- Background: PubMed 21610110Richman EL, Kenfield SA, Stampfer MJ, Paciorek A, Carroll PR, Chan JM. Physical activity after diagnosis and risk of prostate cancer progression: data from the cancer of the prostate strategic urologic research endeavor. Cancer Res. 2011 Jun 1;71(11):3889-95. doi: 10.1158/0008-5472.CAN-10-3932. Epub 2011 May 24.
- Background: PubMed 21205749Kenfield SA, Stampfer MJ, Giovannucci E, Chan JM. Physical activity and survival after prostate cancer diagnosis in the health professionals follow-up study. J Clin Oncol. 2011 Feb 20;29(6):726-32. doi: 10.1200/JCO.2010.31.5226. Epub 2011 Jan 4.
- Background: PubMed 18274783Thorsen L, Courneya KS, Stevinson C, Fossa SD. A systematic review of physical activity in prostate cancer survivors: outcomes, prevalence, and determinants. Support Care Cancer. 2008 Sep;16(9):987-97. doi: 10.1007/s00520-008-0411-7. Epub 2008 Feb 15.
- Pew Internet \& American Life Project. Internet/Broadband Factsheet. 2017;Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rhonda L Bitting, MD principal investigator
Duke Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary Lifestyle, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Pl left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the design features and functionality of the web-app (time frame: 45 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740035, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.