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

NCT07263074 | Recruiting DMC

• 1 other identifier: UOCPC25049
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Myeloid Malignancy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Retained (Feasibility - Retention Rate)

  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 Outcomes (3)

• Mean Change in Decisional Engagement Scale Score

  Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)

• Mean Change in Decisional Conflict Scale Score

  Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)

• Mean Change in Distress Thermometer Score

  Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)

Other Outcomes (1)

• Qualitative Analysis of Patient-Hematologist Discussion of Values and Goals

  Following alloHCT office visit (Day 9 to 194)

Study Arms (2)

Intervention (CHORDS)

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

CHORDS OTHER

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).

Intervention (CHORDS)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>21 years old
• Diagnosis of myeloid cancer (AML, MDS, myelofibrosis, CML, or MDS/MPN)
• Being considered for alloHCT
• Able to provide informed consent
• 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.

You may not qualify if:

• Caregivers
• Age \>18 years old
• 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."
• Caregiver may be paid/professional or informal caregiver
• Able to provide informed consent
• Able to speak English
• \) None
• Hematologists
• \) Hematologists of the patients who agree to enroll on the study who are part of Wilmot Cancer Institute.
• \) None

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

Central Study Contacts

Rachel Rodenbach, MD, MS

CONTACT

585-275-5830; rachel_rodenbach@urmc.rochester.edu

Becky Gravenstede, BA

CONTACT

585-727-4728; becky_gravenstede@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Medicine, Hematology/Oncology (SMD)

Model Details: Assess the feasibility of CHORDS among patients with myeloid cancers referred for alloHCT.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)