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 range

18 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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)

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 range

18 Years

Sex

FEMALE

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)