AML Expressive Writing

Acute Myeloid Leukemia Clinical Trial

Official title:

Expressive Writing to Address Distress in Hospitalized Adults With Acute Myeloid Leukemia (AML): a Pilot Randomized Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04006496
• Other study ID #: Pro00100520
• Status: Terminated
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: January 19, 2022

Study information

• Verified date: August 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: January 19, 2022
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Behavioral:
• Expressive Writing Coaching
For the intervention group, a 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. The expert/coach 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.

Locations

Country	Name	City	State
United States	Duke University Cancer Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Priori	The proportion of enrolled subjects who complete the study (including completing all writing tasks/coaching visits, and completing the surveys). The primary endpoint will be met if at least 80% of enrolled subjects do so.	4 weeks
Secondary	Change in resilience	Change in Resilience based on Connor-Davidson Resilience 10-Item, 5-point scale (0-4), with higher scores reflecting greater resilience.	Baseline, 4 weeks
Secondary	Change in depressive symptoms	Measurements in depression and depressive symptoms based on Patient Health Questionnaire-8 (8-Item diagnostic instrument).	Baseline, 4 weeks
Secondary	Change in patient's mental health status	Change in patient's mental health status based on Generalized Anxiety Disorder (GAD-) (7-Item, self-report anxiety questionnaire).	Baseline, 4 weeks
Secondary	Changes in cancer-related quality of life: Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) (44-Item, 5-level Likert scale	Assessment of cancer-related quality of life, with a specific subscale emphasizing concerns common among patients with leukemias using the Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) (44-Item, 5-level Likert scale.	Baseline, 4 weeks
Secondary	Measurement of brooding and reflective pondering	Measurement of two aspects of rumination using Rumination Response Scale (RRS) (22-Item, 4-Point scale: 1-Almost Never, 2-Sometimes, 3-Often, 4- Almost always, Level Likert Scale instrument)	4 weeks
Secondary	Measurement of aspects of mood, intensity of expressions, and value and meaning.	Aspects of mood, intensity of expressions, and value and meaning will be measured using the Post Writing Reflection Survey (PWR) (5-Item, 10-Point scale (0-10), where 0= Not at All and 10= A Great Deal)	4 weeks