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

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)

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: PEACE Program

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEACE Program; 3 sessions of tailored coping skills related to pelvic examinations	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.; Other Names: Pelvic Exam and Anxiety Coping Skills for Empowerment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)	The adapted STTS-R consists of 18 items that assess satisfaction with the therapist and the intervention on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree).	post pelvic examination (approximately 2-3 months after baseline)
Change in intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)	Change in intervention acceptability from immediately after completion of the 3 sessions (post intervention assessment) to after trying to implement the coping skills during their next pelvic examination (post pelvic exam assessment), using the STTS-R. The adapted STTS-R consists of 18 items that assess satisfaction with the therapist and the intervention on a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree).	post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)
Intervention feasibility as measured by percentage of recruited participants who enrolled	Enrollment logs will capture the number of participants who were recruited and among them, the number that enrolled in the study.	post pelvic examination (approximately 2-3 months after baseline)
Intervention feasibility as measured by attrition	Retention logs will capture the number of participants who did not complete the study protocol (rate of attrition)	post pelvic examination (approximately 2-3 months after baseline)
Intervention feasibility as measured by survey completion	Retention logs will capture the number of participants who completed all assessments	post pelvic examination (approximately 2-3 months after baseline)
Intervention feasibility as measured by home practice completion	Interventionist logs completed at the conclusion of each session will capture the level of home practice completion	post-intervention (within 2 weeks of their next pelvic examination)
Intervention feasibility as measured by participant engagement	Interventionist logs completed at the conclusion of each session will capture the level of participant engagement with a 1 item question rated from 1 (not at all engaged) to 4 (highly engaged).	post-intervention (within 2 weeks of their next pelvic examination)
Intervention feasibility as measured by interventionist fidelity	Fidelity rating forms will be used to measure the level of fidelity to session content for one third of the sessions for the protocol. Each component of the session will be rated from 0 (not covered at all) to 3 (thoroughly covered the topic)	post-intervention (within 2 weeks of their next pelvic examination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety related to examination as measured by the The State Anxiety Scale of the State-Trait Anxiety Inventory	The State Anxiety Scale of the STAI is comprised of 20 items on a 5-point Likert scale, which range from 1 (not at all) through 4 (very much).	baseline, post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)
Change in pain during examination as measured by numeric scales	Numeric scales will be used to assess the average pain during examination, worst pain during examination, and lowest pain during examination, ranging from 0 (no pain) to 10 (pain as bad as you could imagine). The three pain intensity ratings will be averaged to create a total score for pain.	baseline, post pelvic examination (approximately 2-3 months after baseline)

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Rebecca Shelby, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): September 2, 2022
• Study Completion (Actual): September 2, 2022

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: PRO00107843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No