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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03440775
Other study ID # 17-007602
Secondary ID R15CA213035
Status Completed
Phase N/A
First received
Last updated
Start date May 22, 2018
Est. completion date July 23, 2021

Study information

Verified date December 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 203
Est. completion date July 23, 2021
Est. primary completion date July 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Digital stories
Digital story telling videos
Informational videos
Informational videos

Locations

Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (3)

Lead Sponsor Collaborator
Mayo Clinic Arizona State University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Profile of Mood States anxiety and depression subscales from baseline to 4 weeks and 3 months after the intervention
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