Effects of Digital Stories Intervention on Psychosocial Well-being

NCT03654599 | Completed Results

• 2 other identifiers: GR11968R15CA213035
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Digital Storytelling; Narrative; Cancer patients; Psychosocial health; bone marrow transplant

Outcome Measures

Primary Outcomes (1)

• Changes From Baseline Profile of Mood States (POMS) Short Version (Emotional Well-being or /Reduction of Emotional Distress) at 4 Weeks

  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)

Secondary Outcomes (1)

• Changes From Baseline Emotional Well-being (Using the Emotional Acceptance Scale) at 4 Weeks

  Baseline (T1), T2 (after 4-week intervention)

Study Arms (4)

Baseline and Digital Stories (DS) for patients

EXPERIMENTAL

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).

Behavioral: Baseline Surveys; Behavioral: Digital Stories Intervention

Baseline and Information Control (IC) for patients

ACTIVE COMPARATOR

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.

Behavioral: Baseline Surveys; Behavioral: Information Control Intervention

Baseline and Digital Stories (DS) for caregivers

EXPERIMENTAL

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).

Behavioral: Baseline Surveys; Behavioral: Digital Stories Intervention

Baseline and Information Control (IC) for caregivers

ACTIVE COMPARATOR

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.

Behavioral: Baseline Surveys; Behavioral: Information Control Intervention

Interventions

Baseline Surveys BEHAVIORAL

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.

Also known as: Baseline questionnaire

Baseline and Digital Stories (DS) for caregivers; Baseline and Digital Stories (DS) for patients; Baseline and Information Control (IC) for caregivers; Baseline and Information Control (IC) for patients

Digital Stories Intervention BEHAVIORAL

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

Also known as: Digital Storytelling, Narrative-based storytelling

Baseline and Digital Stories (DS) for caregivers; Baseline and Digital Stories (DS) for patients

Information Control Intervention BEHAVIORAL

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.

Baseline and Information Control (IC) for caregivers; Baseline and Information Control (IC) for patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Arizona State University: lead
• Mayo Clinic: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Narration

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Communication

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. Sunny Kim
• Organization: Arizona State University

Sunny.Kim@asu.edu

602-496-6789

Study Officials

• Sunny Kim, Ph.D

  Arizona State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 31, 2018
• Study Start: September 1, 2017
• Primary Completion: January 5, 2021
• Study Completion: July 23, 2021
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)