Clinical trial NCT04006496: AML Expressive Writing
Official title: Expressive Writing to Address Distress in Hospitalized Adults With Acute Myeloid Leukemia (AML): a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomized, pilot feasibility and preliminary efficacy study to test such an intervention among hospitalized patients with AML who are receiving high-dose chemotherapy. Subjects randomized to the intervention arm will participate in a total of four, separate 1-hour expressive writing sessions that include the delivery of writing prompts, instructions, writing analyses, and coaching from a trained facilitator, delivered over the course of 2 weeks. Subjects randomized to the control arm of the study will receive standard care plus neutral writing prompts and instructions, but writing analyses and coaching from a trained facilitator will not be provided.

Detailed 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 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:

1. Introduction to Expressive Writing and Transactional Writing Prompt
2. Personal Story about Your Experience with Cancer
3. Your Cancer form the Perspective of a Different Person
4. Legacy Writing Prompt
5. Mindful Writing Prompt
6. Closure Instructions to Encourage Continuing Expressive Writing

Eligibility criteria: Inclusion Criteria:

* At least age 18
* Capacity to give consent
* Diagnosis of acute myeloid leukemia (AML)
* Fluent in English
* Starting a new line of in-patient chemotherapy at Duke (in the last 4 days)

Exclusion Criteria:

* Patients too sick to participate per clinician discretion
* Patients that are not able to read or understand English

Primary outcomes:
measure: Priori
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in resilience
timeFrame: Baseline, 4 weeks
measure: Change in depressive symptoms
timeFrame: Baseline, 4 weeks
measure: Change in patient's mental health status
timeFrame: Baseline, 4 weeks
measure: Changes in cancer-related quality of life: Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) (44-Item, 5-level Likert scale
timeFrame: Baseline, 4 weeks
measure: Measurement of brooding and reflective pondering
timeFrame: 4 weeks
measure: Measurement of aspects of mood, intensity of expressions, and value and meaning.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Thomas LeBlanc, MD
role: PRINCIPAL_INVESTIGATOR
References: