Poor Sleep Quality Associated With Symptom Burden Among Phase 1 Trial Participants
Patients who slept poorly exhibited greater symptom burden and overall mood disturbance.
Nearly two-thirds of patients with advanced cancer, each of whom participated in early-phase clinical trials, reported poor sleep quality, which was associated with greater fatigue, greater symptom burden, and overall mood disturbance.1
“Sleep quality is often overlooked in advanced cancer patients, compared to other symptoms such as fatigue or pain,” said Goldy C. George, PhD, an instructor in the department of symptom research at MD Anderson Cancer Center, in an interview with Cancer Therapy Advisor.
Dr George was part of a team that evaluated 256 patients with locally advanced or metastatic disease for sleep quality. About half of the patients (46%) were enrolled in a phase 1 trial. The remaining 54% were either considering participating in an early-phase clinical trial, investigating further therapeutic options, or receiving off-protocol therapy.
The index assesses 19 items grouped into 7 components, including sleep duration at night, habitual sleep efficiency, and sleep disturbance; patients who scored greater than 5 on the Pittsburgh Sleep Quality Index were considered poor sleepers. “Poor sleepers” made up 64% of the evaluated patients.
“Fatigue is often the most frequently occurring adverse event in early phase oncology trials, as well as all clinical trials,” Dr George said. “That poor sleep quality is associated with fatigue shows that we might need to reconsider sleep, look at sleep more seriously, and measure it routinely.”
Poor sleepers had a higher overall symptom burden than others, and patients with poor sleep quality displayed higher levels of physical, affective, and cognitive symptoms, as well as greater symptom-related interference with general activity, mood, work, relations with other people, walking, and enjoyment of life.
|Patient-reported reasons for trouble sleeping (by percentage)*|
|Getting up to use the bathroom||65%|
|Awakening during the night or early morning||58%|
|Sleep latency (>30 minutes)||20%|
|Coughing or snoring||17%|
* At least three times weekly
One-third of patients with poor sleep quality reported that maintaining enough enthusiasm to get things done was “somewhat of a problem,” and 12% reported that it was “a very big problem.” Twelve percent reported having trouble with staying awake at least once per week while driving, eating, or socializing.
The National Institute of Health's Precision Medicine Initiative recommendations emphasize collecting data on patient-reported outcomes. Dr George said that sleep should be more routinely assessed in clinical trials.
“Sleep needs to be measured routinely for patients with advanced cancer who are entering phase 1 trials,” she said. “It would be great to do assessments at baseline, as well as look at longitudinal trajectories of sleep, to see whether the sleep quality changes during an early phase trial.
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“This will enable us to better understand whether adverse events are due to experimental therapies; we could then better assess the attribution of such events related to experimental therapies for cancer.”
- 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]