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

City of Hope

Status: Active, not recruiting

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

Treatments: Other: Educational Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04819997

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2021-01138 (Registry Identifier)

20594 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Supportive care (videoconference, questionnaire, survey)

Experimental group

Description:

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.

Treatment:

Other: Educational Intervention