Digital Stories and Psychosocial Wellbeing in Stem Cell Transplant Patients

Stem Cell Transplant Clinical Trial

Official title:

Effects of Digital Stories Intervention on Psychosocial Well-being for Cancer Patients and Caregivers Undergoing Hematopoietic Stem Cell Transplantation (HCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03440775
• Other study ID #: 17-007602
• Secondary ID: R15CA213035
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Stem Cell Transplant

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

External Links

•   Mayo Clinic Clinical Trials