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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Terminated
CT.gov ID
NCT03740035
Collaborator
National Cancer Institute (NCI) (NIH)
4
Enrollment
1
Location
10.2
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: eHealth for Sedentary Behavior

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

Study Type:
Observational
Actual Enrollment :
4 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients
Actual Study Start Date :
Aug 13, 2018
Actual Primary Completion Date :
Oct 17, 2018
Actual Study Completion Date :
Jun 18, 2019

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wake Forest Baptist Medical Center Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT03740035
Other Study ID Numbers:
  • IRB00051239
  • CCCWFU 04118
  • P30CA012197
First Posted:
Nov 14, 2018
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences
Prostate Cancer
eHealth
movement
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Mar 10, 2022