Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial

Abstract

Purpose: There is growing interest to enhance symptom monitoring during routine cancer care using patient-reported outcomes, but evidence of impact on clinical outcomes is limited.

Methods: We randomly assigned patients receiving routine outpatient chemotherapy for advanced solid tumors at Memorial Sloan Kettering Cancer Center to report 12 common symptoms via tablet computers or to receive usual care consisting of symptom monitoring at the discretion of clinicians. Those with home computers received weekly e-mail prompts to report between visits. Treating physicians received symptom printouts at visits, and nurses received e-mail alerts when participants reported severe or worsening symptoms. The primary outcome was change in health-related quality of life (HRQL) at 6 months compared with baseline, measured by the EuroQol EQ-5D Index. Secondary endpoints included emergency room (ER) visits, hospitalizations, and survival.

Results: Among 766 patients allocated, HRQL improved among more participants in the intervention group than usual care (34% v 18%) and worsened among fewer (38% v 53%; P < .001). Overall, mean HRQL declined by less in the intervention group than usual care (1.4- v 7.1-point drop; P < .001). Patients receiving intervention were less frequently admitted to the ER (34% v 41%; P = .02) or hospitalized (45% v 49%; P = .08) and remained on chemotherapy longer (mean, 8.2 v 6.3 months; P = .002). Although 75% of the intervention group was alive at 1 year, 69% with usual care survived the year (P = .05), with differences also seen in quality-adjusted survival (mean of 8.7 v. 8.0 months; P = .004). Benefits were greater for participants lacking prior computer experience. Most patients receiving intervention (63%) reported severe symptoms during the study. Nurses frequently initiated clinical actions in response to e-mail alerts.

Conclusion: Clinical benefits were associated with symptom self-reporting during cancer care.

Trial registration: ClinicalTrials.gov NCT00578006.

Fig 1.

CONSORT diagram. *Computer-inexperienced patients were allocated 2:1, Symptom Tracking and Reporting web-based self-reporting system (STAR) to usual care. ^†Participants went off study before reporting postbaseline quality of life (QOL). ^‡Participants discontinued chemotherapy treatment before 6 months. ^§Last observation carried forward (LOCF) for participants who went off study before 6 months but reported a prior postbaseline QOL.

Fig 2.

Proportion of patients with health-related quality-of-life changes at 6 months compared with baseline. The proportion of patients in each study arm was tabulated for which EuroQol EQ-5D Index scores improved, remained unchanged, or worsened by any amount at 6 months compared with baseline. This analysis was repeated using a threshold for change of six or more points, an amount considered to be clinically meaningful in US cancer populations. Results are shown (A) for all participants, and separately for (B) the computer-experienced subgroup, and (C) the computer-inexperienced subgroup. Analyses included only patients with available baseline and postbaseline EQ-5D scores. P values were calculated using Fisher’s exact test comparing study arms based on the three categories of comparison (improved, unchanged, worsened). STAR, Symptom Tracking and Reporting web-based self-reporting system (study intervention).

Fig 3.

Cumulative incidence of emergency room (ER) visits. The incidence of patients visiting the ER is shown, with death as a competing event. (A) All patients; (B) computer-experienced patients; (C) computer-inexperienced patients. STAR, Symptom Tracking and Reporting web-based self-reporting system (study intervention).