An interventional study of PEACE Program in Anxiety, sponsored by Duke University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Duke University · Not applicable, Interventional, and Treatment
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 16 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
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Exclusion Criteria:
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.
Also known as: Pelvic Exam and Anxiety Coping Skills for Empowerment
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).
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: post-intervention (within 2 weeks of their next pelvic examination)
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).
Time frame: 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.
Time frame: baseline, post pelvic examination (approximately 2-3 months after baseline)
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Duke University