CompletedNot Applicable

Surveillance Pelvic Examination Anxiety: Brief Coping Skills Intervention

United States16 participantsStarted 2022-03-21

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

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)

Intervention feasibility as measured by percentage of recruited participants who enrolled

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

Intervention feasibility as measured by attrition

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

Intervention feasibility as measured by survey completion

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

Intervention feasibility as measured by home practice completion

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

Intervention feasibility as measured by participant engagement

Trial details

NCT IDNCT05285306

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-02

View on ClinicalTrials.gov More Anxiety trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)

Intervention feasibility as measured by percentage of recruited participants who enrolled

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

Intervention feasibility as measured by attrition

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

Intervention feasibility as measured by survey completion

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

Intervention feasibility as measured by home practice completion

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

Intervention feasibility as measured by participant engagement