Effects of Digital Stories Intervention on Psychosocial Well-being

• ClinicalTrials.gov Identifier: NCT03654599
• Recruitment Status: Recruiting
• First Posted: August 31, 2018
• Last Update Posted: May 21, 2021
• Sponsor: Arizona State University
• Collaborators: Mayo Clinic; National Cancer Institute (NCI)
• Information provided by (Responsible Party): Arizona State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Bone Marrow Transplant; Information Disclosure; Hematopoietic Stem Cell Transplantation; Psychosocial Health; Depression; Anxiety; Stress; Narrative	Behavioral: Baseline Surveys; Behavioral: Digital Stories Intervention; Behavioral: Information Control Intervention	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effects of Digital Stories Intervention on Psychosocial Well-being for Cancer Patients and Caregivers Undergoing Hematopoietic Stem Cell Transplantation
• Actual Study Start Date: September 1, 2017
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: July 31, 2022

Arms and Interventions

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).	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.; Other Name: Baseline questionnaire; 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; 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.	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.; Other Name: Baseline questionnaire; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Deb Fisher, Ph.D; 602-496-0931; Deb.Fisher@asu.edu

Contact: Jeff Walker; Jeffrey.J.Walker@asu.edu

Locations

United States, Arizona

Mayo Clinic; Recruiting

Phoenix, Arizona, United States, 85054

Contact: Autumn LaDue 480-342-6065 LaDue.Autumn@mayo.edu

Principal Investigator: Nandita Khera, M.D

Sponsors and Collaborators

Arizona State University

Mayo Clinic

National Cancer Institute (NCI)

Investigators

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

More Information

• Responsible Party: Arizona State University
• ClinicalTrials.gov Identifier: NCT03654599
• Other Study ID Numbers: GR11968; R15CA213035 ( U.S. NIH Grant/Contract )
• First Posted: August 31, 2018
• Last Update Posted: May 21, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arizona State University:

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

Additional relevant MeSH terms:

Depression; Behavioral Symptoms