A Nurse-Led Intervention for Fear of Progression in Advanced Cancer

Study Overview
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Brief Summary
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This clinical trial focuses on a nurse-led program that is designed to help patients cope with worries, fears, and uncertainty about the future. The purpose of this study is to understand if the program is helpful and practical to carry out at medical centers and community clinics. This study may help patients learn more effective ways to cope and respond to your concerns and any unhelpful thoughts.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess the feasibility and acceptability of the revised day by day (DBD) intervention in an academic and community settings. II. To assess the preliminary effects of the revised DBD intervention for reducing fear of progression (FOP) and improving distress, anxiety, depression, metacognitions (beliefs about worry), and mindfulness. OUTLINE: Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks.

Official Title
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A Nurse-Led Intervention for Fear of Progression in Advanced Cancer

Conditions
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Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8

Intervention / Treatment
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* Other: Educational Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stage III or IV gynecologic (GYN) or lung cancer At least 3 months from initial diagnosis Score >= 34 on the Fear of Progression-short form (SF) questionnaire Exclusion Criteria: Severe mental illness (e.g. psychosis) Hospice enrolled Non-English speaking
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (videoconference, questionnaire, survey)<br>Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks. | Other: Educational Intervention<br>* Participate in videoconference session<br>* Other names: Education for Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of recruitment | Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients. | Up to 10 weeks | 
| Feasibility of the intervention | Defined by attrition, attendance, and adherence with home practice activities. Attrition rate will be calculated as number of patients who drop out patients divided by number of enrolled patients. Adherence will be assessed based on the completion rate of home practice activities. | Up to 10 weeks | 
| Acceptability | Will be assessed based on 1) responses to open-ended questions on the exit interview response asking about participants' experience with the intervention and delivery platforms; and 2) a self-report evaluation survey rating usefulness of the session content, home practice activities, testimonials, and delivery platforms. Survey items are rated on a 1-5 Likert scale. An average score of 3 or above will indicate good acceptability. | Up to 10 weeks |