Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
Conditions
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.
Interventions
OTHEREducational Intervention
Participate in videoconference session
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnne Reb
City of Hope Medical Center
Outcome results
None listed