Effects of Digital Stories Intervention on Psychosocial Well-being (NCT03654599) | Clinical Trial Compass
CompletedNot Applicable
Effects of Digital Stories Intervention on Psychosocial Well-being
United States202 participantsStarted 2017-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes From Baseline Profile of Mood States (POMS) Short Version (Emotional Well-being or /Reduction of Emotional Distress) at 4 Weeks