Clinical trial NCT03740035: Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients
Official title: Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Sedentary Lifestyle
Keywords: Prostate Cancer
eHealth
movement
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-11-14
Enrollment: 4
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate cancer patients currently receiving treatment

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Unable to provide informed consent (e.g., delirium).
* Unable to ambulate safely (fall risk).

Primary outcomes:
measure: Assessment of the design features and functionality of the web-app
timeFrame: 45 minutes
measure: System Usability Scale
timeFrame: 30 minutes
measure: Participant reflection on web-app features
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Duke Cancer Institute
name: Rhonda L Bitting, MD
role: PRINCIPAL_INVESTIGATOR
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