Skrutkowski 2008.

Methods	RCT; Unit of allocation: Patient
Participants	Patients with breast or lung cancer receiving treatment in the ambulatory oncology settings. Setting / country: Three outpatient ambulatory oncology clinics in a large university health centre in Quebec / Canada Type of cancer: Breast, lung Phase of care: Any phase Sample size at randomisation: 190
Interventions	Pivot nurse in oncology (PNO) + usual care by clinic nurses: patients and their informal caregiver (if present) met the PNO in the ambulatory setting. The PNO was a baccalaureate‐prepared, experienced palliative care nurse who had received additional training in cancer symptom management and the SMM. The PNO reviewed understanding of the diagnosis, expected side effects of treatment, available resources with the patient. The PNO also identified potential sources of support for the patient by creating a genogram and ecomap. The genogram identified family members and the relationships between them, and the ecomap outlined significant people, agencies, or institutions and their relationships to the family. The PNO assessed patients needs and coping skills, taught specific ways to identify and cope with symptoms, and offered additional education and support as needed. The PNO also coordinated care across treatment modalities and the disease continuum. The PNO particularly advocated for patients during interdisciplinary rounds and developed care plans with referrals to specialised services when needed. The PNO initiated follow‐up telephone calls as needed to provide support, information, coaching, or active listening to patients. Control: Usual care by clinic nurses included symptom assessment and teaching management but was not organised in a formally coordinated model. Patients may not have seen the same nurse at each appointment. Follow‐up by telephone usually was limited to patient‐initiated phone calls.
Outcomes	Patient: Symptom distress, symptoms ‐ fatigue, QoL Process: Use of hospital services, number of clinic appointments
Notes	Length of follow‐up: 6 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "When patients consented, the research assistant contacted one of the investigators for randomisation and assigned the patients to groups. Randomisation was done using a computer‐generated list of numbers that only three of the investigators could access."
Allocation concealment (selection bias)	Low risk	Comment: From the quote reported in the first item's description, we can suppose that not all investigators had access to the computer‐generated list of numbers to conceal allocation to the persons more involved in the trial. However, this was not explicitly stated.
Blinding (performance bias and detection bias) Physical status	High risk
Blinding (performance bias and detection bias) Quality of life	High risk
Blinding (performance bias and detection bias) Use of services	Low risk
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "Twenty‐five of 28 patients who died during the study had lung cancer (Chi‐squared[1] = 12.11, P = 0.001). Another 32 patients (14 with breast cancer and 18 with lung cancer) withdrew. More patients in the usual care group (n = 23) versus the intervention group (n = 9) withdrew (Chi‐squared[1] = 6.68, P = 0.01)." "All analyses were by intention‐to‐treat, meaning all participants data were included, whether or not they provided survey data at each assessment period or died before completing the study." "Repeated measures analyses of variance using linear mixed models were conducted to determine whether the scores in the intervention and usual care groups varied over time and across groups. All analyses were done using Proc Mixed procedure from SAS version 8 (SAS Institute Inc., 1999)." Comment: Reasons for attrition differed between groups. The authors imputed missing data using an appropriate method.
Selective reporting (reporting bias)	Low risk	All outcomes described in Methods are reported in Results.
Other bias	Low risk	No evidence of other bias.
Baseline outcomes similar?	Low risk	Quote: "Repeated measures analyses of variance using linear mixed models were conducted to determine whether the scores in the intervention and usual care groups varied over time and across groups." Comment: Baseline outcome values are not presented but the statistical analysis used takes into account baseline differences.
Baseline characteristics similar?	High risk	Comment: baseline characteristics of participants are presented in Table 1. No statistics were presented but all characteristics appeared to be similar in the 2 study groups, except for proportion of cancer stage III or IV. We tested for differences in cancer stage III or IV proportions between groups using the difference of proportions test and found a significant difference (P = 0.02).
Protected against contamination?	High risk	Comment: Patients were the units of randomisation. Healthcare professionals in charge of patients seem to deliver care within the same setting (ambulatory clinics), but this is not clear. A nurse could have provided care to persons of the two groups.