McCorkle 2009.

Methods	RCT; Unit of allocation: Patient
Participants	Post‐surgical women suspected of having a primary diagnosis of ovarian cancer following abdominal surgery. Setting / country: A North eastern teaching hospital associated with a comprehensive cancer centre in State of Connecticut /USA Type of cancer: Cervical / Ovarian Phase of care: Surveillance, palliative care Sample size at randomisation: 149
Interventions	Specialised care by an advanced practice nurse (APN): APN activities included symptom management and monitoring, emotional support, patient education, coordination of resources, referrals, and direct nursing care. Services included 18 patient contacts during the first 6 months after hospital discharge (home visits, telephone calls, clinic visits). The plan of care and intervention strategies were individually tailored to each patient's needs and personal priorities and were determined jointly by the nurse and patient. Women in high distress were evaluated and monitored by a psychiatric consultation‐liaison nurse (PCLN) as recommended by the National Comprehensive Cancer Network guidelines. In addition, patients received the Symptom Management Toolkit (SMT), a manual containing information on 16 symptoms commonly experienced post‐surgically or with chemotherapy. Control: Attention control group: patients in this group also received the Symptom Management Toolkit (SMT). An initial contact with a research assistant took place at patients' homes where instruction on the use of the SMT was given. At subsequent contacts, research assistants inquired about the presence of symptoms and the utility of the proposed strategies in the SMT in managing the symptom. Patients who had questions outside the content of the SMT were encouraged to call their oncologists. Services included 1 home visit and 3 weekly telephone calls during the first month after hospital discharge and monthly telephone calls for the remaining 5 months of the intervention period.
Outcomes	Patient: QoL, depression, uncertainty, symptom distress
Notes	Length of follow‐up: 6 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from ref #1: "After baseline data were obtained, consented patients were randomised into the intervention or attention control group using the sealed envelope technique."
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Quote from ref #1: "Subsequent data collection visits were completed as in‐person interviews by trained research assistants in the patient’s home." Comment: Outcomes were collected via questionnaire administered to patients. The authors presented the study as a single‐blind randomised clinical trial, but no details are provided on who was blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Proportions of attrition in the 2 study groups were not reported. Overall, there was 15% attrition in the 2 groups.
Selective reporting (reporting bias)	Low risk	All outcomes described in Methods are reported in Results.
Other bias	Low risk	No evidence of any other bias.
Baseline outcomes similar?	Low risk	Quote from ref #1: "At baseline, there were significant differences between the two groups on three outcome variables (CES‐D, uncertainty, and SF‐12‐mental), with the nursing intervention group reporting poorer QOL. However, baseline scores for both groups were adjusted for model testing and were consistent with reports in the literature documenting high psychological and physical impact in high‐risk populations."
Baseline characteristics similar?	Low risk	Quotes from ref #1: "Patients in the intervention and attention control groups did not differ significantly in terms of demographic and clinical characteristics, including stage, primary ovarian site, and new or recurrent disease" "All applicable covariate variables (age less than 60 or greater than and equal to 60, White race or not, recurrent cancer or not, education less than or equal to high school or greater than high school, early or late stage, married or not, number of co‐morbidities, combined income less than or equal to $30 000 or greater than $30 000, emotional distress score equal to or greater than 4 or not, PCLN or not, and adjusted QOL baseline scores) identified in the preliminary analyses were included as well as their interactions with time."
Protected against contamination?	Low risk	Comment: Patients were not randomised by clinics, or practice, but healthcare providers were in charge of the intervention group whereas a research assistant was in charge of the control. The risk of contamination between the two appears to be small.