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

Stage IV Lung Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04819997
• Other study ID #: 20594
• Secondary ID: NCI-2021-0113820
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: December 20, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Lung Carcinoma
• Genital Neoplasms, Female
• Lung Neoplasms
• 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

Intervention

Other:
• Educational Intervention
Participate in videoconference session

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fear of progression (FOP)	Linear mixed model (LMM) for repeated-measures design will be used to examine the changes in FOP and other outcome measures across three time-points. The model will include the time factor, employ compound symmetry covariance structure, and adjust for covariates when necessary. Post Hoc pairwise comparisons with Tukey adjustment will be conducted to test the change in outcomes between time periods. Cohen's D will be used to estimate effect sizes for the changes in outcome measures across time-points (Lakens, 2013).	Up to 10 weeks
Other	Cancer-specific distress	Cancer-specific distress assessed using the Impact of Event Scale-Revised (IES-R) [ Time Frame: Up to week 10 ] Cancer-specific distress will be assessed using the Impact of Event Scale-Revised (IES-R) , 22-item scale consisting of 3 subscales; Intrusion; Avoidance; and; Hyperarousal. Items are scored on a 0-4 response format. Subscale scores are calculated by taking the mean of the subscale responses. Total scores range from 0-88. A score of 24 or greater indicates clinical levels of distress.	Up to 10 weeks
Other	Anxiety	Anxiety will be assessed using the PROMIS-Anxiety 8a, measures fear, dread, worry, hyperarousal, and related somatic symptoms.; The short-form consists of 8 items that are scored on a 0-5 response format. The raw score is calculated by summing the values of the response to each question (range 8-40).; Scores are standardized such that the scale produces continuous T scores with a mean of 50 and a SD of 10, higher scores reflect higher distress.; PROMIS T score thresholds for anxiety are: ? 55 normal; 55-64 mild; 65-74 moderate; =75 severe.	Up to 10 weeks
Other	Depression	Depression will be assessed using the Patient Health Questionnaire (PHQ-9), includes the two major symptom domains: affective and somatic symptoms.; It is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and a score of 10 or greater is considered clinically significant symptoms of depression.; Scores of 0-4, 5-9, 10-14, and =15 represent minimal, mild, moderate, and severe levels of symptom burden.	Up to 10 weeks
Other	Metacognitions	Metacognitions (MCQ-30) will be assessed using the Metacognitions Questionnaire, MCQ-30 is a 30-item questionnaire that assesses beliefs about worry.; It consists of 5 subscales: Positive beliefs about worry; Negative beliefs about worry, Cognitive confidence; Need to control thoughts; and Cognitive self-consciousness. For each subscale, items are scored 1-4 and subscale scores range from 6-24.; Total scores range from 30 to 120; higher scores indicate more dysfunctional metacognitions.	Up to 10 weeks
Other	Mindfulness	Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ-15), the FFMQ-15 assesses five facets of mindfulness: observing, describing, acting with awareness, non-reactivity, and non-judging of inner experience.; Items are rated on a 5-point Likert scale ranging from 1 (never or rarely true) to 5 (very often or always true).; 3 items comprise each subscale and subscale scores range from 3-15. Higher scores indicate greater engagement with mindfulness skills.	Up to 10 weeks
Primary	Feasibility of recruitment	Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients.	Up to 10 weeks
Primary	Feasibility of the intervention	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.	Up to 10 weeks
Primary	Acceptability	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.	Up to 10 weeks