Hematologic Malignancies
Conditions
Keywords
CAR-T, Digital health intervention
Brief summary
The overall purpose of this randomized control trial (RCT) is to determine the clinical effect of a multilevel, RPM-enhanced intervention during and after completion of outpatient CAR-T therapy in 190 patients and their family caregivers (FCGs).
Interventions
OTHEREducational Intervention
Patients and family caregivers that are randomized into the intervetnion arm (Digital health intervention) will receive a 90 day nurse-drive, digital health intervention. Participate in self-management coaching sessions
PROCEDUREHealth Telemonitoring
Wear a FitBit device and use a mobile app for nurse tracking
OTHERQuestionnaire Administration
Ancillary studies
OTHERBest Practice
Given usual care
Sponsors
City of Hope Medical Center
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient Inclusion Criteria Informed Consent and Willingness to Participate 1. Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria 2. Age ≥ 18 years old at the time of enrollment 3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria 4. Relapsed or refractory hematologic malignancy 5. Scheduled to receive outpatient standard of care (SOC) CAR-T therapy 6. Has a FCG committed to living with the patient for the duration of the study Family Caregiver Inclusion Criteria Informed Consent and Willingness to Participate 1. Documented informed consent of the participant and/or legally authorized representative Age and Language Criteria 2. Age ≥ 18 years old at the time of enrollment 3. Ability to read and understand English or Spanish for Questionnaires Nature of Illness and Treatment Related Criteria 4. Family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care
Exclusion criteria
1. An employee who is under the direct/indirect supervision of the PI/ a co-investigator/ the study manager 2. A direct study team member \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient) | Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90 | This is validated measure of 22 CAR-T specific symptoms and other cancer-related symptoms. Symptom severity is rated on a 10-point scale: 1-3 mild, 4-6 moderate, ≥7 severe. Patients also rate how much their symptoms interfere with 6 functional domains: walking, activity, working/housework, relationships, enjoyment of life, and mood. A change in 1.2 points is clinically meaningful and cutoffs for clinical deficits have been defined. Cronbach's α reliability: 82-0.94. |
| Distress Thermometer (DT - FCG) | Baseline, Day 15 - Day 20 post-CAR-T, Day 30, Day 60, and Day 90 | This is an efficient, low-subject-burden measure to evaluate psychological distress over the past week, based on a scale of 0 (no distress) to 10 (extremely distressed). A cut-off of 3/10 indicates a need for intervention, with acceptable sensitivity (94.1%) and specificity (71.2%) compared to the longer Hospital Anxiety and Depression Scale (HADS). The DT has been validated in FCGs, and we chose it for its brevity, accuracy ease of use in remote monitoring, and validity in FCGs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Borgatta Caregiver Burden Scale (FCG) | Baseline, Day 30, Day 60, and Day 90 | This is a 14-item tool designed to measure the impact of caregiving on three dimensions of burden: objective, subjective demand, and subjective stress. Internal consistency for the three dimensions ranges from 0.81-0.90. The ordinal scale ranges from 1-5 (a lot less to a lot more). The following cutoff scores are interpreted as high burden: 1) a score of ≥23 for objective burden, 2) a score of ≥15 for subjective demand, and 3) a score of ≥13.5 for subjective stress. |
| Functional Assessment of Cancer Therapy-General (FACTG - patient) | Baseline, Day 30, Day 60, and Day 90 | This is a cancer-specific version of the FACIT (Functional Assessment of Chronic Illness Therapy) Measurement System. It contains a 27-item compilation of general questions divided into four QoL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. For each item, the respondent indicates on a 5-point Likert scale (0=not at all; 4=very much) how true each statement is for him/her during the past 7d. The FACT-G yields a total score for overall QoL as well as subscale scores. Internal consistency and reliability measures revealed a Cronbach's α of 0.89 for the total FACT-G, and a range of 0.70-0.82 for the four subscales. |
Countries
United States
Contacts
CONTACTVirginia Sun, PhD, RN
PRINCIPAL_INVESTIGATORVirginia Sun, PhD, RN
City of Hope Medical Center
PRINCIPAL_INVESTIGATORSaro Armenian, DO, MPH
City of Hope Medical Center
Outcome results
None listed