Effects of Digital Stories Intervention on Psychosocial Well-being

NCT ID: NCT03654599

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2021-07-23

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Baseline and Digital Stories (DS) for patients

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).

Group Type: EXPERIMENTAL

Baseline Surveys

Intervention Type: 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.

Digital Stories Intervention

Intervention Type: 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

Baseline and Information Control (IC) for patients

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.

Group Type: ACTIVE_COMPARATOR

Baseline Surveys

Intervention Type: 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.

Information Control Intervention

Intervention Type: 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 Digital Stories (DS) for caregivers

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).

Group Type: EXPERIMENTAL

Baseline Surveys

Intervention Type: 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.

Digital Stories Intervention

Intervention Type: 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

Baseline and Information Control (IC) for caregivers

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.

Group Type: ACTIVE_COMPARATOR

Baseline Surveys

Intervention Type: 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.

Information Control Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Baseline questionnaire; Digital Storytelling; Narrative-based storytelling

Eligibility Criteria

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

• 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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunny Kim, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

Locations

Mayo Clinic

Phoenix, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R15CA213035

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GR11968

Identifier Type: -

Identifier Source: org_study_id

NCT03440775

Identifier Type: -

Identifier Source: nct_alias