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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Intervention feasibility as measured by attrition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •unable to provide informed consent
- •major untreated or uncontrolled mental illness
- •hearing impairment that impedes telephone or video calls
结局指标
主要结局
Intervention feasibility as measured by attrition
时间窗: 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)
Intervention feasibility as measured by survey completion
时间窗: post pelvic examination (approximately 2-3 months after baseline)
Retention logs will capture the number of participants who completed all assessments
Intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)
时间窗: 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).
Change in intervention acceptability will be assessed using an adapted version of the Satisfaction with Therapy and Therapist Scale (STTS-R)
时间窗: 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).
Intervention feasibility as measured by percentage of recruited participants who enrolled
时间窗: 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.
Intervention feasibility as measured by home practice completion
时间窗: 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
Intervention feasibility as measured by participant engagement
时间窗: 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).
Intervention feasibility as measured by interventionist fidelity
时间窗: 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)
次要结局
- Change in anxiety related to examination as measured by the The State Anxiety Scale of the State-Trait Anxiety Inventory(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(baseline, post pelvic examination (approximately 2-3 months after baseline))