Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03654599
Status:
COMPLETED
Last Update Posted:
2022-05-23
First Post:
2018-08-27
Brief Title:
Effects of Digital Stories Intervention on Psychosocial Well-being
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
Effects of Digital Stories Intervention on Psychosocial Well-being for Cancer Patients and Caregivers Undergoing Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patientscaregivers as a psychosocial intervention in a randomized controlled trial and to test the effects of digital stories on how 110 patient and caregiver dyads N220 undergoing one of the most rigorous and aggressive treatments cope with treatment-related distress through supportive open dyadic communication and emotional expression
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 patientcaregiver 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 N220 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 investigators 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
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 N220 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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R15CA213035 | NIH | None | httpsreporternihgovquickSearchR15CA213035 |