Clinical trial NCT04819997: A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
Official title: A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-29
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Up to 10 weeks
measure: Feasibility of the intervention
timeFrame: Up to 10 weeks
measure: Acceptability
timeFrame: Up to 10 weeks
Secondary outcomes:
Other outcomes:
measure: Fear of progression (FOP)
timeFrame: Up to 10 weeks
measure: Cancer-specific distress
timeFrame: Up to 10 weeks
measure: Anxiety
timeFrame: Up to 10 weeks
measure: Depression
timeFrame: Up to 10 weeks
measure: Metacognitions
timeFrame: Up to 10 weeks
measure: Mindfulness
timeFrame: Up to 10 weeks
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Anne Reb
role: PRINCIPAL_INVESTIGATOR
References: