Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Acute Myeloid Leukemia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

To determine the feasibility, acceptability, and preliminary efficacy of an expressive writing intervention in this population, the investigators will recruit a total of 30 AML patients (15 patients in each study arm) at time of admission to Duke University Hospital for initiation of inpatient chemo...

To determine the feasibility, acceptability, and preliminary efficacy of an expressive writing intervention in this population, the investigators will recruit a total of 30 AML patients (15 patients in each study arm) at time of admission to Duke University Hospital for initiation of inpatient chemotherapy. To ensure homogeneity among enrolled patients, the investigators will restrict enrollment to within a 4-day window after starting chemotherapy. Although the investigators anticipate little attrition since patients are hospitalized for the entirety of the intervention, some may discontinue the study due to becoming critically ill. The investigators will thus recruit 30 patients in the event of 25% attrition to still meet the goal of at least 10 evaluable patients completing the study in each study arm. To begin the study, patients will complete baseline surveys including demographics, consisting of the following: Conner-Davidson Resilience Scale (CD-RISC)21 • Patient Health Questionnaire-8 (PHQ-8)22 Generalized Anxiety Disorder 7-item (GAD-7)23 • FACT-Leu quality of life scale for leukemia24 Rumination Response Scale (RRS)25 • Demographics Patients will receive the expressive writing intervention twice each week for two weeks for a total of four sessions. For the intervention group (n=15), Dr. Evans (co-investigator and trained expressive writing expert/coach) will introduce the expressive writing concept to consented patients during the first visit, followed by an introduction of the first expressive writing exercise and prompt. Dr. Evans will introduce new writing prompts at each subsequent visit. A script containing each visit's writing prompt and instructions will also be left with the patients for future use and/or reference. The trained clinician will collect, read, and analyze the writing sample using a health coaching technique by: 1) summarizing what the patient wrote, 2) evoking double-sided reflection by reading back the writing sample to the patient, and 3) developing a metaphor and review with the patient. Patients will also have the opportunity to ask the trained clinician questions and receive guidance. Patients consented and randomized into the control group (n=15) will receive the writing prompts with instructions for use from the research study coordinator. Patients in the control group will not interface with the interventionist, nor have their writing samples reviewed and analyzed. The control group will also not receive coaching regarding their writing samples from the interventionist, but the research study coordinator will collect the patients' writing samples at each of the four visits. Of note is that all patients will still receive standard care that includes attention to psychological distress by nursing staff and by physicians and advanced practice clinicians, as well as recreational therapy services, social work services, and available stress management services at the request of the primary cancer care team on the 9100 inpatient ward. After two weeks, participants will complete the same surveys as listed above (except demographics), as well as follow-up assessments at 4-weeks and 3-months. The expressive writing prompts will consist of six modules containing the following expressive writing prompts: Introduction to Expressive Writing and Transactional Writing Prompt Personal Story about Your Experience with Cancer Your Cancer form the Perspective of a Different Person Legacy Writing Prompt Mindful Writing Prompt Closure Instructions to Encourage Continuing Expressive Writing

Tracking Information

NCT #
NCT04006496
Collaborators
Not Provided
Investigators
Principal Investigator: Thomas LeBlanc, MD Duke University