N/A
N=198
Effects of Digital Stories Intervention on Psychosocial Well-being
Bone Marrow Transplant · Information Disclosure · Hematopoietic Stem Cell Transplantation · Psychosocial Health · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03654599 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Changes From Baseline Profile of Mood States (POMS) Short Version (Emotional Well-being or /Reduction of Emotional Distress) at 4 Weeks — 3.3; 3.4; 2.4; 2.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Baseline Surveys (Behavioral); Digital Stories Intervention (Behavioral); Information Control Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arizona State University
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes From Baseline Profile of Mood States (POMS) Short Version (Emotional Well-being or /Reduction of Emotional Distress) at 4 Weeks |
3.3; 3.4; 2.4; 2.8 | — |
| SECONDARY Changes From Baseline Emotional Well-being (Using the Emotional Acceptance Scale) at 4 Weeks |
2.8; 2.8; 3.1; 3.0 | — |
Summary
Patients and caregivers undergoing hematopoietic stem cell transplantation often continue to experience anxiety, depression, isolation, and other psychosocial distress. A narrative-based digital stories intervention has shown promise in a pilot study with breast cancer patients in helping to alleviate emotional distress. This study is designed to test digital stories to be viewed and discussed by other HCT patients/caregivers as a psychosocial intervention in a randomized controlled trial and to test the effects of digital stories on how 110 patient and caregiver dyads (N=220) undergoing one of the most rigorous and aggressive treatments cope with treatment-related distress through supportive open dyadic communication and emotional expression.
Eligibility Criteria
Patient Inclusion Criteria:
- age 18 or older
- recently underwent Hematopoietic cell transplantation (HCT) (within a month after hospital discharge)
- must be able to speak, read, and write in English
- access to a working phone and e-mail account
Patient Exclusion Criteria:
- no primary caregiver
- cognitive impairment that prohibits completion of study assessment
- visual or hearing impairment
- other (e.g., provider non-approval or logistical constraints such as patient moving out of town)
Caregiver Inclusion Criteria:
- age 18 or older
- family caregivers who are identified as a primary caregiver by a patient
- have primary responsibility for the care of patients throughout the HCT process
- Must be able to speak, read, and write in English
- Access to a working phone and e-mail account
Data sourced from ClinicalTrials.gov (NCT03654599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.