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

Sedentary Lifestyle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03740035
• Other study ID #: IRB00051239
• Secondary ID: CCCWFU 04118P30C
• Status: Terminated
• Start date: August 13, 2018
• Est. completion date: June 18, 2019

Study information

• Verified date: March 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 18, 2019
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Sedentary Lifestyle

Intervention

Device:
• eHealth for Sedentary Behavior
Prostate cancer patients will be testing the usability and acceptability of the eHealth web app for sedentary behavior

Locations

Country	Name	City	State
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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* Note: There are 50 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	45 minutes
Primary	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	30 minutes
Primary	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.	30 minutes

External Links

•   Pew Internet & American Life Project. Internet/Broadband Factsheet. 2017;