Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients

Terminated

• Conditions: Sedentary Lifestyle
• Interventions: Device: eHealth for Sedentary Behavior

• Registration Number: NCT03740035
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2018-08-13
• Primary Completion: 2018-10-17
• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-14
• Study Completion: 2019-06-18
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 4

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate Cancer Patients	eHealth for Sedentary Behavior	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.

Primary Outcome Measures

Name	Time	Method
System Usability Scale	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
Assessment of the design features and functionality of the web-app	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.
Participant reflection on web-app features	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.

Trial Locations

Locations (1)

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States