Digital Health Intervention for Self-Management and Telemonitoring in Chimeric Antigen Receptor (CAR-T) Therapy

MD Anderson Symptom Inventory CAR-T module (MDASI-CAR - patient)

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)

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.

Montgomery Borgatta Caregiver Burden Scale (FCG)

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)

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.

COH-QoL-Family (FCG)

This is a 37-item instrument that measures FCG QoL in the physical, psychological, social, and spiritual well-being domains. Ordinal scale ranges from 0-10, with higher scores indicating better QoL. The instrument was revised and tested from 1994-1998 in a study of 219 FCGs of cancer patients. The test-retest reliability was r=0.89 and internal consistency was α r=0.69.

Brief Dyadic Adjustment Scale (DAS - patient, FCG)

This is a 4-item scale designed to assess marital satisfaction for couples married or in a committed relationship. This instrument measures patient/FCG consensus, satisfaction, affectional expression and cohesion that directly assess general communication between couples. Alpha coefficients have been reported from 0.92 to 0.95. The measure will be included as a covariate for analysis. will be used to assess marital satisfaction (Patient, FCG).

FCG Activation in Transitions Tool (FCAT - FCG)

This is a 10-item survey designed to assess FCG's level of engagement and preparedness to care for patients during care transitions. Psychometric assessment was conducted in two randomly equivalent waves of participants (N=434), including FCGs of patients with cancer and/or chronic lung disease. The estimated person-separation reliability was 0.84.

Patient Activation Measure (PAM - patient)

This is a measure of patient "activation", which uses a Guttman-like scale that reflects patient level of engagement and empowerment in their healthcare. Cronbach's α from our pilot study was 0.92.