Surveillance Pelvic Examination Anxiety: Brief Coping Skills Intervention (PEACE)

Duke University

Status: Completed

Conditions: Anxiety

Treatments: Behavioral: PEACE Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05285306

PRO00107843

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female sex
• diagnosis of stage I-IV cervical or endometrial cancer
• 18 years of age or older
• able to speak/read English
• able to give informed consent
• completed cancer treatments within 2-24 months prior to enrollment, and recommended to undergo surveillance pelvic examination at three month intervals
• able to commit to three 45-60 minute visits within the study period
• able to participate in the intervention via the telemedicine modality (e.g., phone or video)

Exclusion criteria

• unable to provide informed consent
• major untreated or uncontrolled mental illness
• hearing impairment that impedes telephone or video calls

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

PEACE Program

Experimental group

Description:

3 sessions of tailored coping skills related to pelvic examinations

Treatment:

Behavioral: PEACE Program