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

Not Applicable

Active, not recruiting

• Conditions: Advanced Lung Carcinoma; Stage III Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Metastatic Malignant Female Reproductive System Neoplasm; Stage IIIB Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8
• Interventions: Other: Educational Intervention

• Registration Number: NCT04819997
• Lead Sponsor: City of Hope Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-02-25
• Study Start: 2021-03-08
• Study First Submitted QC: 2021-03-25
• Study First Posted: 2021-03-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-06-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. Patients with stage III or IV gynecologic (GYN) or lung cancer
2. At least 3 months from initial diagnosis
3. Score >= 34 on the Fear of Progression-short form (SF) questionnaire

Exclusion Criteria

1. Severe mental illness (e.g. psychosis)
2. Hospice enrolled
3. Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (videoconference, questionnaire, survey)	Educational Intervention	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of recruitment	Up to 10 weeks	Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients.
Feasibility of the intervention	Up to 10 weeks	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.
Acceptability	Up to 10 weeks	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States