Effects of Digital Stories Intervention on Psychosocial Well-being

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03654599
• Other study ID #: GR11968
• Secondary ID: R15CA213035
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: July 23, 2021

Study information

• Verified date: May 2022
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: July 23, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Bone Marrow Transplant
• Depression
• Hematopoietic Stem Cell Transplantation
• Information Disclosure
• Narrative
• Psychosocial Health
• Stress

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Arizona State University	Mayo Clinic, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline Profile of Mood States (POMS) short version (Emotional Well-being or /Reduction of Emotional Distress) at 4 weeks and 3 months	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	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	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)