Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05285306
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2022-03-07
Brief Title:
Surveillance Pelvic Examination Anxiety Brief Coping Skills Intervention
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Developing and Pilot Testing a Brief Intervention to Reduce Anxiety During Pelvic Examinations Among Female Cancer Survivors Pelvic Examination and Anxiety Coping Skills for Empowerment PEACE
Status:
COMPLETED
Status Verified Date:
2021-11
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:
PEACE
Brief Summary:
The purpose of this study is to test the feasibility and acceptability of a brief coping skills training program addressing anxiety and pain related to surveillance pelvic examinations for female gynecologic cancer survivors
Detailed Description:
The investigators have developed and manualized a coping skills training intervention for female gynecologic cancer patients that aims to reduce anxiety related to surveillance pelvic examinations Pelvic Examination and Anxiety Coping Skills for Empowerment PEACE The investigators propose a proof-of concept pilot study to evaluate the acceptability and feasibility of the coping skills intervention The study will be conducted by Duke University Participants N16 will receive the 3-session telemedicine coping skills intervention Participants will complete assessments at baseline post-intervention within 2 weeks before their next scheduled pelvic examination and post pelvic examination 2-3 months after the baseline assessment Study aims are Aim 1 Assess intervention acceptability and feasibility through quantitative measurement and qualitative feedback from semi-structured interviews and Aim 2 Graphically depict patterns of change in outcome variables and intervention targets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None