Trial Outcomes & Findings for Effects of Digital Stories Intervention on Psychosocial Well-being (NCT NCT03654599)
NCT ID: NCT03654599
Last Updated: 2024-10-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
202 participants
Primary outcome timeframe
Baseline (T1), T2 (after 4-week intervention)
Results posted on
2024-10-09
Participant Flow
Four enrolled participants were excluded from the study before assignment to groups due to patients' health issues (e.g., readmitted to the hospital, illness, and/or complications after the transplant).
Participant milestones
| Measure |
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: 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
|
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: 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: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
92
|
|
Overall Study
COMPLETED
|
78
|
70
|
|
Overall Study
NOT COMPLETED
|
28
|
22
|
Reasons for withdrawal
| Measure |
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: 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
|
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: 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: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
12
|
|
Overall Study
Death
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
Baseline Characteristics
This baseline characteristic was only collected for patients
Baseline characteristics by cohort
| Measure |
Baseline and Digital Stories (DS) for Patients
n=53 Participants
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: 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
|
Baseline and Digital Stories (DS) for Caregivers
n=53 Participants
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: 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
|
Baseline and Information Control (IC) for Patients
n=46 Participants
n-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: 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: 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 Information Control (IC) for Caregivers
n=46 Participants
n-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: 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: 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.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Cancer diagnosis
Myelodysplastic Syndrome
|
11 Participants
n=53 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
11 Participants
n=46 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
22 Participants
n=99 Participants • This baseline characteristic was only collected for patients
|
|
Cancer diagnosis
Leukemia
|
10 Participants
n=53 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
14 Participants
n=46 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
24 Participants
n=99 Participants • This baseline characteristic was only collected for patients
|
|
Cancer diagnosis
Other
|
3 Participants
n=53 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
2 Participants
n=46 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
5 Participants
n=99 Participants • This baseline characteristic was only collected for patients
|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 14.3 • n=53 Participants
|
56.4 years
STANDARD_DEVIATION 12.9 • n=53 Participants
|
53.1 years
STANDARD_DEVIATION 14.2 • n=46 Participants
|
51.4 years
STANDARD_DEVIATION 16.4 • n=46 Participants
|
54.9 years
STANDARD_DEVIATION 14.2 • n=198 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=53 Participants
|
42 Participants
n=53 Participants
|
18 Participants
n=46 Participants
|
30 Participants
n=46 Participants
|
112 Participants
n=198 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=53 Participants
|
11 Participants
n=53 Participants
|
28 Participants
n=46 Participants
|
16 Participants
n=46 Participants
|
86 Participants
n=198 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=53 Participants
|
7 Participants
n=53 Participants
|
8 Participants
n=46 Participants
|
8 Participants
n=46 Participants
|
28 Participants
n=198 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=53 Participants
|
44 Participants
n=53 Participants
|
37 Participants
n=46 Participants
|
37 Participants
n=46 Participants
|
164 Participants
n=198 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=53 Participants
|
2 Participants
n=53 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=46 Participants
|
6 Participants
n=198 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=53 Participants
|
2 Participants
n=53 Participants
|
3 Participants
n=46 Participants
|
3 Participants
n=46 Participants
|
10 Participants
n=198 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=53 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=198 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=53 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=198 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=53 Participants
|
2 Participants
n=53 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=46 Participants
|
6 Participants
n=198 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=53 Participants
|
46 Participants
n=53 Participants
|
38 Participants
n=46 Participants
|
37 Participants
n=46 Participants
|
167 Participants
n=198 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=53 Participants
|
3 Participants
n=53 Participants
|
4 Participants
n=46 Participants
|
4 Participants
n=46 Participants
|
14 Participants
n=198 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=53 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=198 Participants
|
|
Region of Enrollment
United States
|
53 Participants
n=53 Participants
|
53 Participants
n=53 Participants
|
46 Participants
n=46 Participants
|
46 Participants
n=46 Participants
|
198 Participants
n=198 Participants
|
|
Education
High School
|
4 Participants
n=53 Participants
|
6 Participants
n=53 Participants
|
13 Participants
n=46 Participants
|
9 Participants
n=46 Participants
|
32 Participants
n=198 Participants
|
|
Education
Some college
|
20 Participants
n=53 Participants
|
18 Participants
n=53 Participants
|
15 Participants
n=46 Participants
|
18 Participants
n=46 Participants
|
71 Participants
n=198 Participants
|
|
Education
4-year college degree
|
18 Participants
n=53 Participants
|
21 Participants
n=53 Participants
|
10 Participants
n=46 Participants
|
10 Participants
n=46 Participants
|
59 Participants
n=198 Participants
|
|
Education
Graduate degree
|
11 Participants
n=53 Participants
|
8 Participants
n=53 Participants
|
8 Participants
n=46 Participants
|
9 Participants
n=46 Participants
|
36 Participants
n=198 Participants
|
|
Marital Status
Married
|
39 Participants
n=53 Participants
|
39 Participants
n=53 Participants
|
34 Participants
n=46 Participants
|
31 Participants
n=46 Participants
|
143 Participants
n=198 Participants
|
|
Marital Status
Never Married
|
3 Participants
n=53 Participants
|
3 Participants
n=53 Participants
|
2 Participants
n=46 Participants
|
6 Participants
n=46 Participants
|
14 Participants
n=198 Participants
|
|
Marital Status
Divorced, widowed or separated
|
8 Participants
n=53 Participants
|
6 Participants
n=53 Participants
|
6 Participants
n=46 Participants
|
3 Participants
n=46 Participants
|
23 Participants
n=198 Participants
|
|
Marital Status
Not married
|
3 Participants
n=53 Participants
|
5 Participants
n=53 Participants
|
4 Participants
n=46 Participants
|
6 Participants
n=46 Participants
|
18 Participants
n=198 Participants
|
|
Employment Status
Employed full time
|
25 Participants
n=53 Participants
|
21 Participants
n=53 Participants
|
17 Participants
n=46 Participants
|
16 Participants
n=46 Participants
|
79 Participants
n=198 Participants
|
|
Employment Status
Employed part time
|
2 Participants
n=53 Participants
|
7 Participants
n=53 Participants
|
2 Participants
n=46 Participants
|
7 Participants
n=46 Participants
|
18 Participants
n=198 Participants
|
|
Employment Status
Not employed
|
26 Participants
n=53 Participants
|
25 Participants
n=53 Participants
|
27 Participants
n=46 Participants
|
23 Participants
n=46 Participants
|
101 Participants
n=198 Participants
|
|
Health insurance
Private Coverage
|
34 Participants
n=53 Participants
|
36 Participants
n=53 Participants
|
31 Participants
n=46 Participants
|
29 Participants
n=46 Participants
|
130 Participants
n=198 Participants
|
|
Health insurance
Medicaid
|
1 Participants
n=53 Participants
|
1 Participants
n=53 Participants
|
2 Participants
n=46 Participants
|
2 Participants
n=46 Participants
|
6 Participants
n=198 Participants
|
|
Health insurance
Medicare
|
16 Participants
n=53 Participants
|
15 Participants
n=53 Participants
|
7 Participants
n=46 Participants
|
14 Participants
n=46 Participants
|
52 Participants
n=198 Participants
|
|
Health insurance
Other
|
2 Participants
n=53 Participants
|
1 Participants
n=53 Participants
|
6 Participants
n=46 Participants
|
1 Participants
n=46 Participants
|
10 Participants
n=198 Participants
|
|
Cancer diagnosis
Multiple Myeloma
|
19 Participants
n=53 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
9 Participants
n=46 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
28 Participants
n=99 Participants • This baseline characteristic was only collected for patients
|
|
Cancer diagnosis
Lymphoma
|
10 Participants
n=53 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
10 Participants
n=46 Participants • This baseline characteristic was only collected for patients
|
0 Participants
This baseline characteristic was only collected for patients
|
20 Participants
n=99 Participants • This baseline characteristic was only collected for patients
|
|
Transplant type
Autologous
|
14 Participants
n=53 Participants
|
14 Participants
n=53 Participants
|
11 Participants
n=46 Participants
|
11 Participants
n=46 Participants
|
50 Participants
n=198 Participants
|
|
Transplant type
Allogeneic
|
39 Participants
n=53 Participants
|
39 Participants
n=53 Participants
|
33 Participants
n=46 Participants
|
33 Participants
n=46 Participants
|
144 Participants
n=198 Participants
|
|
Main source of support
Spouse
|
35 Participants
n=53 Participants
|
32 Participants
n=53 Participants
|
29 Participants
n=46 Participants
|
25 Participants
n=46 Participants
|
121 Participants
n=198 Participants
|
|
Main source of support
Sibling
|
8 Participants
n=53 Participants
|
2 Participants
n=53 Participants
|
9 Participants
n=46 Participants
|
1 Participants
n=46 Participants
|
20 Participants
n=198 Participants
|
|
Main source of support
Son/Daughter
|
22 Participants
n=53 Participants
|
4 Participants
n=53 Participants
|
13 Participants
n=46 Participants
|
7 Participants
n=46 Participants
|
46 Participants
n=198 Participants
|
|
Main source of support
Friends
|
9 Participants
n=53 Participants
|
2 Participants
n=53 Participants
|
7 Participants
n=46 Participants
|
3 Participants
n=46 Participants
|
21 Participants
n=198 Participants
|
|
Main source of support
Parents
|
10 Participants
n=53 Participants
|
9 Participants
n=53 Participants
|
9 Participants
n=46 Participants
|
6 Participants
n=46 Participants
|
34 Participants
n=198 Participants
|
|
Main source of support
Other
|
6 Participants
n=53 Participants
|
4 Participants
n=53 Participants
|
4 Participants
n=46 Participants
|
4 Participants
n=46 Participants
|
18 Participants
n=198 Participants
|
PRIMARY outcome
Timeframe: Baseline (T1), T2 (after 4-week intervention)Population: HCT patients and caregivers
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.
Outcome measures
| Measure |
Baseline and Digital Stories (DS)
n=78 Participants
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: 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
|
Baseline and Information Control (IC)
n=70 Participants
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: 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: 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.
|
|---|---|---|
|
Changes From Baseline Profile of Mood States (POMS) Short Version (Emotional Well-being or /Reduction of Emotional Distress) at 4 Weeks
Post-Intervention
|
2.4 score on a scale
Standard Deviation 3.1
|
2.8 score on a scale
Standard Deviation 3.1
|
|
Changes From Baseline Profile of Mood States (POMS) Short Version (Emotional Well-being or /Reduction of Emotional Distress) at 4 Weeks
Baseline
|
3.3 score on a scale
Standard Deviation 3.0
|
3.4 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline (T1), T2 (after 4-week intervention)Population: HCT patients and caregivers
The 13-item Emotional Acceptance (EA) Scale assesses the extent to which subjects are accepting toward their feelings, with statements such as "I naturally and easily attend to my feelings." Respondents estimate the percentage of time each statement is true, in increments of 10 (0 = never/not at all to 100 = always/perfectly; total score = mean item rating). In Dr. Weihs' sample of 91 breast cancer patients, internal consistency was strong (= .92), as was 15-month test re-test reliability (r = .58).
Outcome measures
| Measure |
Baseline and Digital Stories (DS)
n=78 Participants
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: 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
|
Baseline and Information Control (IC)
n=70 Participants
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: 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: 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.
|
|---|---|---|
|
Changes From Baseline Emotional Well-being (Using the Emotional Acceptance Scale) at 4 Weeks
Baseline
|
2.8 score on a scale
Standard Deviation 0.57
|
2.8 score on a scale
Standard Deviation 0.59
|
|
Changes From Baseline Emotional Well-being (Using the Emotional Acceptance Scale) at 4 Weeks
Post-intervention
|
3.1 score on a scale
Standard Deviation 0.64
|
3.0 score on a scale
Standard Deviation 0.49
|
Adverse Events
Baseline and Digital Stories (DS) for Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Baseline and Digital Stories (DS) for Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Baseline and Information Control (IC) for Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Baseline and Information Control (IC) for Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place