A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
Primary Purpose
Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm, Stage III Lung Cancer AJCC v8
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Lung Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Patients with stage III or IV gynecologic (GYN) or lung cancer
- At least 3 months from initial diagnosis
- Score >= 34 on the Fear of Progression-short form (SF) questionnaire
Exclusion Criteria:
- Severe mental illness (e.g. psychosis)
- Hospice enrolled
- Non-English speaking
Sites / Locations
- City of Hope Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supportive care (videoconference, questionnaire, survey)
Arm 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.
Outcomes
Primary Outcome Measures
Feasibility of recruitment
Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04819997
First Posted
February 25, 2021
Last Updated
April 4, 2023
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04819997
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supportive care (videoconference, questionnaire, survey)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention
Intervention Description
Participate in videoconference session
Primary Outcome Measure Information:
Title
Feasibility of recruitment
Description
Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients.
Time Frame
Up to 10 weeks
Title
Feasibility of the intervention
Description
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.
Time Frame
Up to 10 weeks
Title
Acceptability
Description
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.
Time Frame
Up to 10 weeks
Other Pre-specified Outcome Measures:
Title
Fear of progression (FOP)
Description
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).
Time Frame
Up to 10 weeks
Title
Cancer-specific distress
Description
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.
Time Frame
Up to 10 weeks
Title
Anxiety
Description
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.
Time Frame
Up to 10 weeks
Title
Depression
Description
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.
Time Frame
Up to 10 weeks
Title
Metacognitions
Description
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.
Time Frame
Up to 10 weeks
Title
Mindfulness
Description
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.
Time Frame
Up to 10 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with stage III or IV gynecologic (GYN) or lung cancer
At least 3 months from initial diagnosis
Score >= 34 on the Fear of Progression-short form (SF) questionnaire
Exclusion Criteria:
Severe mental illness (e.g. psychosis)
Hospice enrolled
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Reb
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
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