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Acute Myeloid LeukemiaNCT04006496

AML Expressive Writing

A study testing Expressive Writing Coaching in people with Acute Myeloid Leukemia, run by Duke University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Expressive Writing Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
4 Nov 2019to 19 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University Cancer Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Expressive Writing Coaching
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expressive Writing CoachingBehavioural

    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.

Study groups in NCT04006496
Study groupRoleWhat they receive
Experimental: InterventionExperimentalIn-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.
Receives: Behavioral: Expressive Writing Coaching
ControlNo interventionPatients 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (6)
  1. Change in resilience

    Change in Resilience based on Connor-Davidson Resilience 10-Item, 5-point scale (0-4), with higher scores reflecting greater resilience.

    Measured: Baseline, 4 weeks

  2. Change in depressive symptoms

    Measurements in depression and depressive symptoms based on Patient Health Questionnaire-8 (8-Item diagnostic instrument).

    Measured: Baseline, 4 weeks

  3. 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).

    Measured: Baseline, 4 weeks

  4. 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.

    Measured: Baseline, 4 weeks

  5. 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)

    Measured: 4 weeks

  6. 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)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start4 Nov 2019
  3. Primary completion19 Jan 2022
  4. Study completion19 Jan 2022

Why it stopped: Recruitment issues due to COVID-19 pandemic.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04006496
Sponsor's protocol ID
Pro00100520
Status last verified
Aug 2022
First submitted
1 Jul 2019
Last updated
15 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Expressive Writing Coaching in people with Acute Myeloid Leukemia, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment issues due to COVID-19 pandemic.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Priori (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.

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