University of Rochester
Rochester, New York, 14642, United States
Location status: Recruiting
NCT Number: NCT07263074
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).
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Not applicable
Rochester, New York, 14642, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patients
Inclusion criteria
Exclusion criteria
1) Patients with psychiatric or cognitive conditions which the hematologist believes prohibits informed consent or compliance with study procedures
Caregivers
Inclusion criteria
Exclusion criteria
Hematologists
Inclusion criteria
Exclusion criteria
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).
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.
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).
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Becky Gravenstede, BA
CONTACT
Rachel Rodenbach, MD, MS
CONTACT
University of Rochester
Other
Feasibility and Preliminary Efficacy of a Digital Story Intervention to Facilitate Decision-Making in Patients With Myeloid Cancers Considering Allogeneic Hematopoietic Cell Transplantation
Acronym: CHORDS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06594445
Acute Myeloid Leukemia, Bone Marrow Diseases
Minneapolis, Minnesota, United States
View Trial DetailsNCT07619287
Myeloid Malignancy
Kurralta Park, South Australia, Australia
View Trial DetailsNCT04501120
Hematologic Diseases, Hemic and Lymphatic Diseases
Beijing, Beijing Municipality, China
View Trial DetailsNCT06129734
Acute Myeloid Leukemia, Hematologic Diseases
Cleveland, Ohio, United States
View Trial Details