NCT05285306

Surveillance Pelvic Examination Anxiety: Brief Coping Skills Intervention

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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 (N=16) 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.

Conditions

• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	PEACE Program	This pilot will consist of 3 individual telemedicine sessions to teach cognitive behavioral coping skills and provide education related to gynecologic cancer surveillance and psychological distress.

Timeline

• Start date: 2022-03-21
• Primary completion: 2022-09-02
• Completion: 2022-09-02
• First posted: 2022-03-17
• Last updated: 2023-05-11

Locations

1 site across 1 country: United States