- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03654599
Effects of Digital Stories Intervention on Psychosocial Well-being
Effects of Digital Stories Intervention on Psychosocial Well-being for Cancer Patients and Caregivers Undergoing Hematopoietic Stem Cell Transplantation
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
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Phoenix, Arizona, United States, 85054
- Mayo Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
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:
|
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:
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.
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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)
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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.
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Baseline (T1), T2 (after 4-week intervention), and T3 (3 month after the intervention)
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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)
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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.
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Baseline (T1), T2 (after 4-week intervention), and T3 (3 month after the intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sunny Kim, Ph.D, Arizona State University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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