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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- Introduction to Expressive Writing and Transactional Writing Prompt
- Personal Story about Your Experience with Cancer
- Your Cancer form the Perspective of a Different Person
- Legacy Writing Prompt
- Mindful Writing Prompt
- Closure Instructions to Encourage Continuing Expressive Writing
- Conditions
- Acute Myeloid Leukemia
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Change in depressive symptoms
Measurements in depression and depressive symptoms based on Patient Health Questionnaire-8 (8-Item diagnostic instrument).
Measured: Baseline, 4 weeks
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
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
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
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.
- First posted5 Jul 2019
- Study start4 Nov 2019
- Primary completion19 Jan 2022
- Study completion19 Jan 2022
Why it stopped: Recruitment issues due to COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas LeBlanc, MD, Principal investigator, Duke University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing to Address Distress in Hospitalized Adults With Acute Myeloid Leukemia (AML): a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04006496
- Acronym / sponsor ID
- Pro00100520
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment issues due to COVID-19 pandemic.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 19 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Introduction to Expressive Writing and Transactional Writing Prompt
- Personal Story about Your Experience with Cancer
- Your Cancer form the Perspective of a Different Person
- Legacy Writing Prompt
- Mindful Writing Prompt
- Closure Instructions to Encourage Continuing Expressive Writing
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention | Experimental | Behavioral: Expressive Writing CoachingIn-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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients too sick to participate per clinician discretion
- Patients that are not able to read or understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive Writing CoachingFor 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. | Behavioural | Experimental: Intervention |
Primary outcome
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.
6 secondary outcomes
Change in resilience
Time frame: Baseline, 4 weeks
Change in depressive symptoms
Time frame: Baseline, 4 weeks
Change in patient's mental health status
Time frame: Baseline, 4 weeks
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
Measurement of brooding and reflective pondering
Time frame: 4 weeks
Measurement of aspects of mood, intensity of expressions, and value and meaning.
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Recruitment issues due to COVID-19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas LeBlanc, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
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.