Digital Stories and Psychosocial Wellbeing in Stem Cell Transplant Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 17-007602
NCT ID: NCT03654599
Sponsor Protocol Number: 17-007602
About this study
The proposed research will use a double-blind randomized controlled design to pilot test a model for how stories shared by a panel of HCT survivors impact the psychosocial well-being of the digital stories (DS) intervention condition of 55 patients who recently underwent HCT and their respective caregivers compared with 55 people in an information control (IC) condition and their caregivers (total 220 participants; N=110 per condition). Participants, recruited from the Mayo Clinic Arizona Cancer Center, will be randomly assigned to one of two conditions: the DS intervention or the IC video condition. Participants will questionnaires at baseline (T1), after the 4-week intervention (T2), and 3 months (100 days) later (T3).
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Criteria
Subject population (children, adults, groups): All patients and caregivers undergoing HCT at Mayo Clinic in Arizona for hematological disorders.
Inclusion (patients):
- recently underwent HCT (within a month after hospital discharge)
- are able to speak, read, and write in English
- are 18 years or older
- have access to a working phone and e-mail account.
Inclusion (caregivers):
- family caregivers who are identified as a primary caregiver by a patient, and have primary responsibility for the care of patients throughout the HCT process, including basic medical procedures, taking the patient to and from the hospital frequently as well as other household and other role responsibilities
- are able to speak, read, and write in English
- are 18 years or older
- have access to a working phone and e-mail account.
Exclusion Criteria:
- Participants who are not identified as primary caregivers
- Participants with a visual or hearing impairment
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Nandita Khera, M.D., M.P.H. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available