Effects of Digital Stories Intervention on Psychosocial Well-being

May 20, 2022 updated by: Arizona State University

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

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.

Study Overview

Detailed Description

Patients and caregivers undergoing hematopoietic stem cell transplantation (HCT) are at particular risk for reduced psychological and social well-being due to the rigorous and unique nature of the transplant experience, such as prolonged immunosuppression and multiple post HCT complications resulting in frequent hospitalizations. However, few studies have evaluated interventions to alleviate psychosocial distress for both patients and caregivers, and those have yielded inconclusive results. A narrative-based (storytelling) approach may be an effective intervention tool for HCT patients and caregivers coping with psychosocial distress. The preliminary data show that stories shared by individuals in which a range of emotional expression or resolutions are described, may have beneficial effects on emotional well-being. In a recent pilot study of a 3-day digital storytelling workshop, investigators produced a series of digital videos with narratives from a panel of post-HCT patients. The purpose of this study is to use these digital stories (DS), to be viewed and discussed by HCT patient/caregiver dyads, as a therapeutic intervention and to examine influences on both patients' and caregivers' psychosocial status. This cost-effective, non-invasive, and easy-to-deliver psychosocial support vehicle has never been formally tested as an intervention for HCT patients or patient-caregiver dyads.

To build upon investigators' preliminary studies and to pilot test the efficacy of this series of DS, 110 adult patients undergoing HCT at the Mayo Clinic Arizona and patient respective adult caregivers (N=220 total participants) will be randomized to either (a) an intervention using DS (dyadic exposure to four 5-minute modules) or (b) an information control (IC) video group (dyadic exposure to four videos containing only information about post-HCT care) followed by encouragement to discuss as a dyad. Exposure will occur once per week over 4 weeks via a secure web-based data collection platform (REDcap) with a weekly email notification and reminder phone call. Using investigator's model of Narrative Effects on Socio-Emotional Well-Being, we will also examine expected mediating factors to determine how stories may "work" to reduce psychosocial distress by fostering emotional processing, acceptance, and dyadic disclosure of emotions.

Study Type

Interventional

Enrollment (Actual)

202

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

    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic

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

Genders Eligible for Study

All

Description

Patient Inclusion Criteria:

  • age 18 or older
  • recently underwent Hematopoietic cell transplantation (HCT) (within a month after hospital discharge)
  • must be able to speak, read, and write in English
  • access to a working phone and e-mail account

Patient Exclusion Criteria:

  • no primary caregiver
  • cognitive impairment that prohibits completion of study assessment
  • visual or hearing impairment
  • other (e.g., provider non-approval or logistical constraints such as patient moving out of town)

Caregiver Inclusion Criteria:

  • age 18 or older
  • family caregivers who are identified as a primary caregiver by a patient
  • have primary responsibility for the care of patients throughout the HCT process
  • Must be able to speak, read, and write in English
  • Access to a working phone and e-mail account

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Baseline and Digital Stories (DS)
In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture before the random assignment to DS arm. Eight Digital Stories Intervention (4 patient and 4 caregiver stories about hematopoietic stem cell transplantation (HCT) over the course of 4 weeks (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each).
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.
Other Names:
  • Baseline questionnaire
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
Other Names:
  • Digital Storytelling
  • Narrative-based storytelling
ACTIVE_COMPARATOR: Baseline and Information Control (IC)
In-person baseline surveys using the web-based data collection platform, Research Electronic Data Capture (REDCap) before the random assignment to IC arm. Eight Information Control Intervention videos containing only information about post-HCT care (as opposed to story/narrative) over the course of 4 weeks (2 videos per week) with a weekly email notification and reminder phone call.
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.
Other Names:
  • Baseline questionnaire
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from Baseline Profile of Mood States (POMS) short version (Emotional Well-being or /Reduction of Emotional Distress) at 4 weeks and 3 months
Time Frame: Baseline (T1), T2 (after 4-week intervention), and T3 (3 month after the intervention)
Emotional Well-Being (Reduction of Emotional Distress) will be measured using the Profile of Mood States (POMS) short version (15 items, 5-point Likert scale; 0=not at all, 4=extremely). The POMS is one of the most frequently used and validated scales in studies of psychosocial interventions for cancer patients. The POMS Total Mood Disturbance (TMD) score has been shown to be most sensitive to interventions designed to facilitate emotional expression.The POMS consists of the TMD dimensions (tension-anxiety; depression-dejection; anger-hostility; and confusion-bewilderment) (Cronbach's a = .93) to be used in the current study as the primary outcome measure; and two others (fatigue-inertia; vigor-activity) will be documented. Total of Mood Disturbance= (anxious+depression+anger+fatigue)- vigor (Range from 12 to 48). The higher values represent a worse emotional well-being.
Baseline (T1), T2 (after 4-week intervention), and T3 (3 month after the intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from Baseline social well-being (using the general Functional Assessment of Cancer Therapy (FACT-G) social well-being scale) at 4 weeks and 3 months
Time Frame: Baseline (T1), T2 (after 4-week intervention), and T3 (3 month after the intervention)
The general Functional Assessment of Cancer Therapy (FACT-G) social well-being scale (8 items, 5-point Likert scale (0 = not at all, 4 = very much, Score range: 0-28 [summed]). The FACT-G is widely used in clinical trials specifically to measure four areas of quality of life, but only the social well-being (Cronbach's a= .86), dimension will be used in the proposed study. The higher values represent a better social well-being.
Baseline (T1), T2 (after 4-week intervention), and T3 (3 month after the intervention)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sunny Kim, Ph.D, Arizona State University

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)

September 1, 2017

Primary Completion (ACTUAL)

January 5, 2021

Study Completion (ACTUAL)

July 23, 2021

Study Registration Dates

First Submitted

August 27, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (ACTUAL)

August 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR11968
  • R15CA213035 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Depression

Clinical Trials on Baseline Surveys

3
Subscribe