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

NCT ID: NCT03740035

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-13
• Study Completion Date: 2019-06-18

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.

Conditions

Sedentary Lifestyle

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

eHealth for Sedentary Behavior

Intervention Type: DEVICE

Prostate cancer patients will be testing the usability and acceptability of the eHealth web app for sedentary behavior

Interventions

eHealth for Sedentary Behavior

Prostate cancer patients will be testing the usability and acceptability of the eHealth web app for sedentary behavior

Intervention Type: DEVICE

Eligibility 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).

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rhonda L Bitting, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Cancer Institute

Locations

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

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Related Links

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

Other Identifiers

CCCWFU 04118

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

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IRB00051239

Identifier Type: -

Identifier Source: org_study_id