Considering alloHCT: Opportunities for Patient Reflection During Decision-Making Via Digital Stories (CHORDS)

July 2, 2026 updated by: Rachel Rodenbach, University of Rochester

Feasibility and Preliminary Efficacy of a Digital Story Intervention to Facilitate Decision-Making in Patients With Myeloid Cancers Considering Allogeneic Hematopoietic Cell Transplantation

This is a two-arm pilot randomized trial that assesses the feasibility and preliminary efficacy of a digital story and values clarification intervention (Considering alloHCT: Opportunities for Patient Reflection During Decision-Making via Digital Stories [CHORDS]) compared to usual care among patients with myeloid cancers considering allogeneic hematopoietic cell transplantation (alloHCT).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Our proposed intervention is Considering alloHCT: Opportunities for Patient Reflection During Decision-Making via Digital Stories (CHORDS), which includes: 1) real-life digital stories of individuals with similar experiences who previously underwent consultation for allogeneic hematopoietic cell transplantation and their caregivers and 2) explicit values clarification exercises designed to help patients reflect on their emotions and clarify what matters to them, including a) an interactive workbook, and b) best-worst scaling. Together, they help patients reflect on their values and prioritize their own needs and goals, enhance emotional awareness, and gain experiential knowledge from peers to better understand the real-life implications of treatment risks and benefits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Patients

Inclusion criteria:

  1. Age >21 years old
  2. Diagnosis of myeloid cancer (e.g. AML, MDS, myelofibrosis, CML, or MDS/MPN)
  3. Being considered for alloHCT
  4. Able to provide informed consent
  5. Able to speak English. The reason for this is because the digital stories have been created in the English language and their multimedia form cannot easily be translated.

Exclusion criteria 1) Patients with psychiatric or cognitive conditions which the hematologist believes prohibits informed consent or compliance with study procedures

Caregivers

Inclusion criteria:

  1. Age >18 years old
  2. Selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters."
  3. Caregiver may be paid/professional or informal caregiver
  4. Able to provide informed consent
  5. Able to speak English

Exclusion Criteria:

1) None

Hematologists

Inclusion criteria:

1) Hematologists of the patients who agree to enroll on the study who are part of WCI.

Exclusion criteria

1) None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention (CHORDS)
The CHORDS intervention consists of 1) digital stories created by individuals who previously underwent consultation for alloHCT and 2) explicit values clarification exercises designed to help patients reflect on their emotions and clarify what matters to them, including a) an interactive workbook, and b) best-worst scaling (BWS).
Other: CHORDS
The CHORDS intervention consists of 1) digital stories created by individuals who previously underwent consultation for alloHCT and 2) explicit values clarification exercises designed to help patients reflect on their emotions and clarify what matters to them, including a) an interactive workbook, and b) best-worst scaling (BWS).
No Intervention: Usual Care
Patients randomized to the usual care arm will receive standard of care. Patients (and their caregivers when available) randomized to usual care will not participate in CHORDS. Patients and caregivers will complete baseline (T1) and post-alloHCT office visit (T3, T4, T5) assessments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Retained (Feasibility - Retention Rate)
Time Frame: From enrollment (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
Feasibility will be assessed based on the percentage of enrolled participants who complete both the intervention and post-intervention secondary outcome assessments. The number of participants who complete all study procedures will be divided by the total number enrolled to calculate the retention rate. Higher percentages indicate greater feasibility.
From enrollment (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change in Decisional Engagement Scale Score
Time Frame: Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
Engagement in decision making will be assessed using the Decisional Engagement Scale, a self-reported measure evaluating patient involvement and perceived shared decision making. A single score will be derived according to scale instructions. Higher scores indicate greater engagement in decision making. There are 10 items in the scale, with each items score ranging from 0 to 10 (range 0-100 for the entire scale).
Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
Mean Change in Decisional Conflict Scale Score
Time Frame: Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
Decisional conflict will be assessed using the Decisional Conflict Scale, a validated self-report instrument that measures personal uncertainty in making health-related decisions. The total score is derived by averaging item responses according to the scoring manual (range 0-100). Higher scores indicate greater decisional conflict (worse outcome), while lower scores indicate less conflict (improvement).
Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
Mean Change in Distress Thermometer Score
Time Frame: Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)
Psychological distress will be measured using the NCCN Distress Thermometer, a single-item visual analog scale ranging from 0 ("no distress") to 10 ("extreme distress"). Higher scores indicate greater distress.
Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative Analysis of Patient-Hematologist Discussion of Values and Goals
Time Frame: Following alloHCT office visit (Day 9 to 194)
Audio recordings of alloHCT office visits will be transcribed and analyzed using qualitative methods to identify the presence and nature of discussions related to patient values and treatment goals.
Following alloHCT office visit (Day 9 to 194)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UOCPC25049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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