Evaluating PEACE Intervention for the Reduction of Anxiety in Survivors Undergoing Surveillance Pelvic Exams

Status: closed to accrual

This clinical trial develops and evaluates a cognitive behavioral intervention (Pelvic Examination and Anxiety Coping Skills for Empowerment [PEACE]) for the alleviation of anxiety in cancer survivors undergoing surveillance pelvic exams. Gynecologic cancer survivors often experience pelvic examinations as a stressful experience resulting in discomfort and anxiety symptoms. The PEACE intervention is a cognitive behavioral intervention that focuses on reducing anxiety during pelvic examination through mindfulness and relaxation techniques. This clinical trial evaluates the PEACE intervention for its ability to reduce anxiety in survivors undergoing a pelvic exam.

Inclusion Criteria

HEALTHCARE PROVIDERS:
Oncology healthcare provider (e.g., radiation, medical, and surgical oncologists; gynecologic oncology physician assistants, nurses; advanced practice professionals; pelvic floor physical therapists; oncology behavioral health providers)
Provides care for endometrial or cervical cancer survivors receiving cancer surveillance and follow-up care in the outpatient setting
CANCER SURVIVORS:
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
SURVIVORS PARTICIPATING IN THE PILOT STUDY: Completed cancer treatments within 2-24 months prior to enrollment (they can be eligible if they are currently on maintenance therapy)
SURVIVORS PARTICIPATING IN THE PILOT STUDY: Will be recommended to undergo surveillance pelvic examination at three month intervals
SURVIVORS PARTICIPATING IN THE PILOT STUDY: Able to commit to three approximately 45-60 minute (maximum length, 75 minutes in cases where an extended visit is needed to be responsive to participant needs and questions) visits within the study period
SURVIVORS PARTICIPATING IN THE PILOT STUDY: Able to participate in the intervention via the telemedicine modality (e.g., phone or video)
SURVIVORS PARTICIPATING IN THE PILOT STUDY: Able to complete electronic or mailed questionnaires
SURVIVORS PARTICIPATING IN THE PILOT STUDY: Able to access home practice recordings which will be available via the internet
PARTICIPANT STAKEHOLDER: May have completed treatments greater than 24 months ago
PARTICIPANT STAKEHOLDER: Will be recommended to undergo surveillance pelvic examination at three month intervals
PARTICIPANT STAKEHOLDER: Able to commit to three approximately 45-60 minute (maximum length, 75 minutes in cases where an extended visit is needed to be responsive to participant needs and questions) visits within the study period
PARTICIPANT STAKEHOLDER: Able to participate in the intervention via the telemedicine modality (e.g., phone or video)
PARTICIPANT STAKEHOLDER: Able to complete electronic or mailed questionnaires; and able to access home practice recordings which will be available via the internet

Exclusion Criteria

CANCER SURVIVORS: Unable to provide informed consent
CANCER SURVIVORS: Major untreated or uncontrolled mental illness (e.g., psychosis)
CANCER SURVIVORS: A hearing impairment that impedes telephone or video calls

PRIMARY OBJECTIVES:

Ia. Develop the intervention manual and provider stakeholder interview guide informed by qualitative data analyzed from 10 patient stakeholder interviews.

Ib. Conduct 10 provider stakeholder interviews, analyze the data, and refine the intervention manual and pilot study procedures (e.g., intervention and assessment protocol, protocols for interventionist training, supervision and fidelity evaluation), incorporating expert feedback and feedback from 1 participant stakeholder.

II. Assess intervention acceptability and feasibility (primary outcomes) through qualitative feedback and self-report measures.

III. Graphically depict patterns of change in outcome variables and intervention targets.

OUTLINE:

PART I: Patients and healthcare providers attend interviews over 30-45 minutes and the participant stakeholder attends 3 mock behavioral intervention sessions over 45-60 minutes each and provides feedback to support intervention development.

PART II: Patients receive the PEACE intervention over 3 sessions during the 8 weeks leading up to their next surveillance pelvic examination, complete surveys over 20-45 minutes, and attend an interview over 30-45 minutes within 2 weeks after their pelvic examination.

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Evaluating PEACE Intervention for the Reduction of Anxiety in Survivors Undergoing Surveillance Pelvic Exams

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