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Recruiting NCT07263074

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

No phase Interventional Myeloid Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CHORDS.
Who it may be relevant to
Registry conditions: Myeloid Malignancy. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

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.

Interventions

  • 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).

Primary outcome measures

  • 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)]
Secondary outcome measures (3)
  • 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)]
  • 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)]
  • Mean Change in Distress Thermometer Score [Time frame: Baseline (Day -30 to Day 0) to 2 weeks post-alloHCT office visit (Day 9-19)]

Eligibility criteria

Patients

Inclusion criteria

  • Age >21 years old
  • Diagnosis of myeloid cancer (e.g. 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.

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

Caregivers

Inclusion criteria

  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Rochester — Rochester

Identifiers

NCT: NCT07263074 · UOCPC25049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗