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Trial record 60 of 2692 for:    prostate cancer | ( Map: United States )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03740035
Recruitment Status : Active, not recruiting
First Posted : November 14, 2018
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sedentary Lifestyle Behavioral: eHealth for Sedentary Behavior Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : October 17, 2018
Estimated Study Completion Date : October 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: eHealth for Sedentary Behavior
Prostate cancer patients will be testing the usability and acceptability of the eHealth web app for sedentary behavior




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Men with biological male reproductive organs
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740035


Locations
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United States, North Carolina
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
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Principal Investigator: Rhonda L Bitting, MD Wake Forest University Health Sciences

Additional Information:
Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03740035     History of Changes
Other Study ID Numbers: IRB00051239
CCCWFU 04118 ( Other Identifier: NCI )
P30CA012197 ( U.S. NIH Grant/Contract )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases