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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-08

Study Completion Date

2026-06-15

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.

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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.

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (videoconference, questionnaire, survey)

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Participate in videoconference session

Interventions

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Educational Intervention

Participate in videoconference session

Intervention Type OTHER

Other Intervention Names

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Education for Intervention

Eligibility Criteria

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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