Clinical trial NCT05285306: Surveillance Pelvic Examination Anxiety: Brief Coping Skills Intervention
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)
timeFrame: post pelvic examination (approximately 2-3 months after baseline)
measure: Change in intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)
timeFrame: post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)
measure: Intervention feasibility as measured by percentage of recruited participants who enrolled
timeFrame: post pelvic examination (approximately 2-3 months after baseline)
measure: Intervention feasibility as measured by attrition
timeFrame: post pelvic examination (approximately 2-3 months after baseline)
measure: Intervention feasibility as measured by survey completion
timeFrame: post pelvic examination (approximately 2-3 months after baseline)
measure: Intervention feasibility as measured by home practice completion
timeFrame: post-intervention (within 2 weeks of their next pelvic examination)
measure: Intervention feasibility as measured by participant engagement
timeFrame: post-intervention (within 2 weeks of their next pelvic examination)
measure: Intervention feasibility as measured by interventionist fidelity
timeFrame: post-intervention (within 2 weeks of their next pelvic examination)
Secondary outcomes:
measure: Change in anxiety related to examination as measured by the The State Anxiety Scale of the State-Trait Anxiety Inventory
timeFrame: baseline, post-intervention (within 2 weeks of their next pelvic examination), post pelvic examination (approximately 2-3 months after baseline)
measure: Change in pain during examination as measured by numeric scales
timeFrame: baseline, post pelvic examination (approximately 2-3 months after baseline)
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Rebecca Shelby, PhD
role: PRINCIPAL_INVESTIGATOR
References: