Effects of Digital Stories Intervention on Psychosocial Well-being

NCT03654599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2024-10-09

Study results available
· View outcomes & findings →

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.

Conditions

  • Bone Marrow Transplant
  • Information Disclosure
  • Hematopoietic Stem Cell Transplantation
  • Psychosocial Health
  • Depression
  • Anxiety
  • Stress
  • Narrative

Interventions

BEHAVIORAL

Baseline Surveys

Baseline surveys contained a series of scaled questions, including sociodemographic variables (age, sex, cancer type, and etc), profile of mood states, social well-being, emotional processing and acceptance.

BEHAVIORAL

Digital Stories Intervention

Digital Stories Intervention Videos contain the following content: caregiver burden, positive and cognitive coping, support from other family and friends, fear of losing the patient, spirituality, guilt of being sick, and expressing emotions/feelings

BEHAVIORAL

Information Control Intervention

Information Control Intervention Videos include Information about post-HCT. The topics in the IC include specific guidelines to return to wellness post HCT through (1) an exercise plan, (2) a nutrition (dietary) plan, (3) pain management, (4) information about the complications, (5) caregiver responsibilities, (6) social support, (7) preventing from infections, and (8) symptom management. Participants randomized to the IC will receive the full set of DS modules only after the final 3-month post-intervention data collection point has passed and they can view them as desired.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER
  • National Cancer Institute (NCI)

    collaborator NIH
  • Arizona State University

    lead OTHER

Principal Investigators

  • Sunny Kim, Ph.D · Arizona State University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2021-01-05
Completion
2021-07-23

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654599 on ClinicalTrials.gov