Table 4.
Study characteristics
| Author and year | Country | Cancer type | Sample size (consented) | Type of therapy | Trial design | PROs used | Timing of PRO assessments | Was at least one PRO validated? | Intervention effect | Quality grading |
|---|---|---|---|---|---|---|---|---|---|---|
| Hoogland et al. (2021) [36] | USA | Relapsed/refractory large B-cell lymphoma | 103 | CAR-T (axi-cel) | Observational | SF-36 OR PROMIS-29* and PRO-CTCAE | Toxicities baseline and 14, 30, 60 and 90 days after treatment QoL baseline and 90 days | Yes | Depression improved overtime but not significant | 7 |
| Knight et al. (2020) [37] | USA | Relapsed refractory B-cell non-Hodgkin lymphoma and chronic lymphocytic leukaemia | 16 | CAR-20/19 T cells | Single-arm intervention study | Inventory of depression and anxiety symptoms (IDAS), Brief Pain Inventory (BPI), Fatigue Severity Index (FSI), Pittsburgh Sleep Quality Index (PSQI) | Baseline, day 14/28/90 post-intervention | Yes | Depression improved overtime but not significant | 7 |
| Li et al. (2017) [45] | China | Melanoma | 104 | Adoptive immunotherapy using cytokine-induced killer (CIK) cells | Retrospective-two-arm CIK and conventional or conventional treatment only | Simplified questionnaire about QoL | Every 3 months for the first year and every 6 months onwards | No | Some reported improvements (appetite, sleep, weight gain, pain) but not statistically significant | 6 |
| Martin et al. (2020) [38] | USA | Multiple myeloma | 68 | CAR-T (ciltacabtagene autoleucel) | Single-arm intervention study | EORTC QLQ-C30 and multiple myeloma (MY20), EQ-5D-5L) | Baseline, 7, 28, 56, 78, & 100 | Yes | Clinically meaningful improvements at day 100 (pain, fatigue, physical function, global health, thinking about illness, worries about future) | 7 |
| Mullane et al. (2020) [40] | USA | Relapse/refractory non-Hodgkin lymphoma (NHL), acute lymphoblastic leukaemia (ALL), chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM) | 58 | CAR-T | Observational | PROMIS Scale v1.2 Global Health, PROMIS-29 Profile v2.1, 30 additional questions, including questions recognitive function | Single questionnaire | Yes | Clinically meaningful differences (global physical health, anxiety/depression) | 7 |
| Ruark et al. (2021) [41] | USA | Relapsed/refractory ALL, NHL, or CLL | 40 | CAR-T (CD-19) | Observational | PROMIS Scale v1.2 Global Health, PROMIS-29 Profile v2.1, 30 additional questions, including four questions recognitive function | Single questionnaire | Yes | No clinical meaningful differences in scores. Some scores for anxiety and/or depression and Global Mental Health indicated worse health than general population | 7 |
| Wang et al. (2021) [42] | USA | Haematological | 60 | CAR-T | Cross-sectional observational study | MD Anderson Symptom Inventory; PROMIS-29; EQ-5D-5L; single-item HRQOL; CAR T-cell therapy-specific symptoms | Single questionnaire | Yes | Observational only | 7 |
| Laetsch et al. (2019) [43] | International (Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Norway, Spain, USA) |
Relapsed or refractory B-cell acute lymphoblastic leukaemia |
75 | Tisagenlecleucel | Single-arm open-label phase 2 | The Pediatric Quality-of-Life Inventory (PedsQL) and the European Quality-of-Life-5 Dimensions (EQ-5D) questionnaire | Day 28, then once a month for 6 months, then every 3 months until month 12, and then will be followed up for 5 years | Yes | Minimal clinically important differences observed from month three onwards | 7 |
| Shah et al. (2020) [47] | International (USA, Canada, Belgium, France, Japan, Germany, Italy, Spain) | Relapsed and refractory multiple myeloma | 128 | CAR-T (Ide-cel) | Single-arm interventional study | EORTC Quality of Life C30 (QLQ-C30) and Myeloma Module (MY20) questionnaires and EQ-5D-5L | Baseline, months 1–6, 9, 12 and 15 post-infusion | Yes | Clinically meaningful differences seen on specific subscales of each PRO | 7 |
| Sidana et al. (2019) [39] | USA | Haematological | 93 | CAR-T | Longitudinal observational cohort study | FACT-G, PROCTCAE, Neuro-QoL v2 | Baseline, week 2, months 1,2, 3 | Yes | Statistically significant difference in QoL at each time point | 5 |
| Maziarz et al. (2020) [44] | USA, Europe, Japan, Canada and Australia | Relapsed/refractory diffuse large B-cell lymphoma | 115 | Tisagenlecleucel | Single, open-label, phase 2 study | Function Assessment of Cancer Therapy-Lymphoma (FACT-Lym), SF-36 | Baseline, months 3, 6, 12 and 18 | Yes | SF-36 instruments showed improvement above the minimal clinically important differences on 5 of 8 subscales | 7 |
*The questionnaire was changed during the study so earlier participants completed SF-36 and later participants completed PROMIS-29