Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02783755
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2016-05-24
Brief Title:
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is two-fold First the investigator will develop a low-literacy Mobile Pain Coping Skills Training mPCST protocol for cancer patients with pain ie therapist manual patient manual including handouts and the smartphone materials as well as a beta version of the basic smartphone components with the assistance of experts in the field Next an iterative development design using focus groups with women who have breast cancer and pain accrued from medically underserved areas will be used to refine the developed mPCST protocol and basic smart phone components The protocol-designed to reduce cancer pain and disability in patients with low literacy in medically underserved areas-will be delivered via tele-video conferencing sessions in the community clinic The smartphone tools eg simple text messages images and preloaded intervention content will allow the intervention to extend into the patients homes The second study purpose is to pilot test the feasibility acceptability and efficacy of the developed protocol The investigator will also obtain an estimate of the effect size of the developed protocol to decrease pain Focus group data will be managed and evaluated in a systematic format using a grounded theory approach Data analyses for the pilot testing period of the study will be assessed by examining accrual attrition and adherence to the intervention Simple t-tests will be used to examine pre- to post-intervention differences in pain and the other outcomes of interest There are minimal risk or safety issues related to this study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None