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AML Expressive Writing

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ClinicalTrials.gov Identifier: NCT04006496
Recruitment Status : Suspended (COVID-19 restrictions)
First Posted : July 5, 2019
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Behavioral: Expressive Writing Coaching Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Expressive Writing to Address Distress in Hospitalized Adults With Acute Myeloid Leukemia (AML): a Pilot Randomized Clinical Trial
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : April 15, 2021


Arm Intervention/treatment
Experimental: Experimental: Intervention
In-patient, Chemotherapy patients in this arm will receive the expressive writing intervention twice each week for two weeks. These writing samples will be reviewed and analyzed. These patients will receive coaching from an expert expressive writing coach and will be allowed to ask questions and receive guidance. All patients will receive standard of care treatment in addition to the 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.

No Intervention: Control
Patients in the control group will not interface with the expressive writing coach for guidance nor have their writing samples reviewed and analyzed. All patients in the control arm will still receive standard care



Primary Outcome Measures :
  1. Priori [ Time Frame: 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Change in resilience [ Time Frame: Baseline, 4 weeks ]
    Change in Resilience based on Connor-Davidson Resilience 10-Item, 5-point scale (0-4), with higher scores reflecting greater resilience.

  2. Change in depressive symptoms [ Time Frame: Baseline, 4 weeks ]
    Measurements in depression and depressive symptoms based on Patient Health Questionnaire-8 (8-Item diagnostic instrument).

  3. Change in patient's mental health status [ Time Frame: Baseline, 4 weeks ]
    Change in patient's mental health status based on Generalized Anxiety Disorder (GAD-) (7-Item, self-report anxiety questionnaire).

  4. Changes in cancer-related quality of life: Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) (44-Item, 5-level Likert scale [ Time Frame: Baseline, 4 weeks ]
    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.

  5. Measurement of brooding and reflective pondering [ Time Frame: 4 weeks ]
    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)

  6. Measurement of aspects of mood, intensity of expressions, and value and meaning. [ Time Frame: 4 weeks ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006496


Locations
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United States, North Carolina
Duke University Cancer Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Thomas LeBlanc, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04006496    
Other Study ID Numbers: Pro00100520
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms