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

March 8, 2022 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Prostate cancer patients currently receiving treatment

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: eHealth for Sedentary Behavior
Prostate cancer patients will be testing the usability and acceptability of the eHealth web app for sedentary behavior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
45 minutes
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
30 minutes
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Rhonda L Bitting, MD, Duke Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 13, 2018

Primary Completion (ACTUAL)

October 17, 2018

Study Completion (ACTUAL)

June 18, 2019

Study Registration Dates

First Submitted

November 9, 2018

First Submitted That Met QC Criteria

November 9, 2018

First Posted (ACTUAL)

November 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00051239
  • P30CA012197 (U.S. NIH Grant/Contract)
  • CCCWFU 04118 (OTHER: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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