Digital Stories and Psychosocial Wellbeing in Stem Cell Transplant Patients

December 21, 2023 updated by: Mayo Clinic

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

203

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Behavioral: Digital stories
Digital story telling videos
Sham Comparator: Comparator
Behavioral: Informational videos
Informational videos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Profile of Mood States
Time Frame: from baseline to 4 weeks and 3 months after the intervention
anxiety and depression subscales
from baseline to 4 weeks and 3 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)
Arizona State University

Investigators

  • Principal Investigator: Nandita Khera, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Actual)

July 23, 2021

Study Completion (Actual)

July 23, 2021

Study Registration Dates

First Submitted

December 27, 2017

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 21, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 17-007602
  • R15CA213035 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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