Patients participating in early-phase clinical trials should be assessed for sleep quality, as poor sleep quality is associated with greater fatigue, symptom burden, and mood disturbance, according to a report published in the journal Cancer.1
Data on sleep quality for patients with advanced cancer participating in phase 1 clinical trials is limited. Poor sleep quality is not documented as an adverse event, and neither is its association with fatigue, one of the most frequently reported adverse effects.
In this report, authors assessed sleep, fatigue, symptom burden, and mood with the Pittsburgh Sleep Quality Index (PSQI), the Brief Fatigue Inventory, the MD Anderson Symptom Inventory (MDASI), and the Brief Profile of Mood States, respectively, in 256 patients recruited from an early-phase clinic for targeted therapy.
The study sample was 51.2% female, mean age 58 ± 0.8 years. Eastern Cooperative Oncology Group performance status, determined from medical records, was 0 or 1 in 90% of participants.
Sixty-four percent of the study sample were poor sleepers, with global PSQI score greater than 5. Higher levels of fatigue (P <.001), symptom burden (P <.001), and overall mood disturbance (P <.001) were seen in poor sleepers, compared with good sleepers. In addition, fatigue-related and symptom-related interference with daily activities (all P values <.001) was greater in poor sleepers than in good sleepers.
The MDASI disturbed-sleep item correlated well with the global PSQI score (Pearson’s r = 0.679, P <.001), suggesting its usefulness as a screening tool for patient-reported sleep quality in early-phase clinical
The authors conclude that poor sleep quality was a significant problem for patients with advanced cancer who are participating in phase 1 clinical trials, and poor sleep quality is associated with greater fatigue, symptom burden, and mood disturbance. Therefore, sleep quality should be routinely assessed in these patients.
1. George GC, Iwuanyanwu EC, Anderson KO, et al. Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a clinic for early-phase oncology clinical trials. Cancer 2016 Jul 14. doi:10.1002/cncr.30182. [Epub ahead of print]