Surveillance Pelvic Examination Anxiety: Brief Coping Skills Intervention

NCT05285306 | Completed

• 1 other identifier: PRO00107843
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Change in anxiety related to examination as measured by the The State Anxiety Scale of the State-Trait Anxiety Inventory

  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

  baseline, post pelvic examination (approximately 2-3 months after baseline)

Study Arms (1)

PEACE Program

EXPERIMENTAL

3 sessions of tailored coping skills related to pelvic examinations

Behavioral: PEACE Program

Interventions

PEACE Program 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.

Also known as: Pelvic Exam and Anxiety Coping Skills for Empowerment

PEACE Program

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female sex
• diagnosis of stage I-IV cervical or endometrial cancer
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Rebecca Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 17, 2022
• Study Start: March 21, 2022
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: May 11, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)