AML Expressive Writing

NCT04006496 | Terminated

• 1 other identifier: Pro00100520
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in resilience

  Baseline, 4 weeks

• Change in depressive symptoms

  Baseline, 4 weeks

• Change in patient's mental health status

  Baseline, 4 weeks

• Changes in cancer-related quality of life: Functional Assessment of Cancer Therapy - Leukemia (FACT-Leu) (44-Item, 5-level Likert scale

  Baseline, 4 weeks

• Measurement of brooding and reflective pondering

  4 weeks

Study Arms (2)

Experimental: Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Expressive Writing Coaching BEHAVIORAL

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.

Experimental: Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Cancer Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Thomas LeBlanc, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: November 4, 2019
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)