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Completed

NCT Number: NCT05285306

Surveillance Pelvic Examination Anxiety: Brief Coping Skills Intervention

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Pelvic Exam and Anxiety Coping Skills for Empowerment

Primary outcomes

  1. Intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)

    Time frame: post pelvic examination (approximately 2-3 months after baseline)

    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).

  2. Change in intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)

    Time frame: post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)

    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).

  3. Intervention feasibility as measured by percentage of recruited participants who enrolled

    Time frame: post pelvic examination (approximately 2-3 months after baseline)

    Enrollment logs will capture the number of participants who were recruited and among them, the number that enrolled in the study.

  4. Intervention feasibility as measured by attrition

    Time frame: post pelvic examination (approximately 2-3 months after baseline)

    Retention logs will capture the number of participants who did not complete the study protocol (rate of attrition)

  5. Intervention feasibility as measured by survey completion

    Time frame: post pelvic examination (approximately 2-3 months after baseline)

    Retention logs will capture the number of participants who completed all assessments

  6. Intervention feasibility as measured by home practice completion

    Time frame: post-intervention (within 2 weeks of their next pelvic examination)

    Interventionist logs completed at the conclusion of each session will capture the level of home practice completion

  7. Intervention feasibility as measured by participant engagement

    Time frame: post-intervention (within 2 weeks of their next pelvic examination)

    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).

  8. Intervention feasibility as measured by interventionist fidelity

    Time frame: post-intervention (within 2 weeks of their next pelvic examination)

    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)

Secondary outcomes

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

    Time frame: baseline, post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)

    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).

  2. Change in pain during examination as measured by numeric scales

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

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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)

Acronym: PEACE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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