Surveillance Pelvic Examination Anxiety: Brief Coping Skills Intervention

NCT ID: NCT05285306

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2022-09-02

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 (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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PEACE Program

3 sessions of tailored coping skills related to pelvic examinations

Group Type: EXPERIMENTAL

PEACE Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Pelvic Exam and Anxiety Coping Skills for Empowerment

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Shelby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

PRO00107843

Identifier Type: -

Identifier Source: org_study_id