Goodwin 2003.

Methods	Cluster‐RCT; Unit of allocation: Surgeon; Stratified by: Size of breast cancer practice
Participants	Women aged 65 and older newly diagnosed with breast cancer identified within 2 months of diagnosis. Setting / country: 13 community and 2 public hospitals in southeast Texas / USA Type of cancer: Breast Phase of care: Any phase Sample size at randomisation: 335
Interventions	Community‐based nurse case management plus patient education: Over the period of intervention, the nurse case manager interacted with the client through a combination of home visits, telephone conversations, being present at physician appointments, visits to client if she was hospitalised and contacts made at other community locations. The case manager roles were to educate, counsel, advocate for the patient and coordinate patient care. The model for the case management intervention was based on previous literature and consists of four stages of activities: assessment, planning, implementation, and evaluation. The planning phase included goal setting, decision making, advocacy, and planning with the patient, family, and healthcare professionals. The implementation phase included interventions such as managing symptoms, offering emotional support, teaching, enlisting social support, coordinating care, providing referrals, and accompanying patients to physician visits. In the evaluation phase, the intervention included monitoring progress and documenting follow‐up. The case managers did not advocate for a specific treatment (e.g. breast‐conserving surgery vs mastectomy). Rather, the goal was to ensure that the patient was fully informed of her options and that the surgeon and other providers were aware of all matters relevant to ensuring a successful outcome. The three case managers in this study were baccalaureate‐degree registered nurses with previous experience with case management in other settings. Each received 40 hours of training from advanced practice nurses in oncology and geriatrics on treatment and complications of breast cancer, availability of community resources, assessment of older patients, and methods of communicating with treating physicians. They were educated in the evaluation and treatment guidelines promulgated by The National Cancer Institute and were given patient‐education brochures produced by the American Cancer Society and the National Cancer Institute. The case management services were provided for 12 months from first contact with the client. Patient need determined the frequency of contact, although minimum contact during the intervention period included at least one in‐person assessment and monthly telephone calls. A checklist outlining the steps in the case management process and the specific activities under each step served as a prompt (available by request). The case manager also employed a number of standard assessment instruments, including activity of daily living scale,instrumental activity of daily living scale, Mini‐Mental State Examination, Geriatric Depression Scale, short form, Comprehensive Functional Assessment, and a Home Safety Checklist. These assessments were usually completed during the first two encounters with the patient. This information was used by the nurse case manager to assess patient needs and was not used or analysed by the investigators. Control: No details provided
Outcomes	Patient: Arm function Process: Receipt of appropriate treatment, treatment received in the first 6 months after diagnosis, proportion of patients receiving evaluation during follow‐up
Notes	Length of follow‐up: 12 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The surgeons were stratified by total number of new breast cancer patients seen in the previous year (≤ 5, 6 to 24, 25 to 39, and ≥ 40 patients) and then randomised into intervention and control groups. Randomisation was done at the level of the surgeon to reduce the chance of contamination of the control group from the case management intervention. Size of breast cancer practice was chosen as a stratification variable because of previous findings that breast cancer patient volume was a determinant of the extent of evaluation and appropriateness of treatment. Within each stratum, randomisation was performed in blocks of four to ensure balance in the number of surgeons assigned to each group. Surgeons in solo practice (n = 39) were randomised as individuals, whereas surgeons in group practice (21 surgeons in six groups) were randomised by group. The six surgeons at the two public hospitals were treated as two groups and stratified separately so that one public hospital was in the intervention group and one in the control group."
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quotes from reference #1: "Bilingual interviewers, who were blinded to the purpose or structure of the study, interviewed control and intervention subjects at 2 and 12 months after diagnosis at home." "Six months after diagnosis, a trained data abstractor blinded to the purposes of the study abstracted the hospital and surgeons’ medical records for dates of diagnosis and treatment, cancer stage and size, histology, hormone receptor status, diagnostic tests obtained, type of surgery, other treatments recommended or prescribed, and consultations obtained (abstracting forms available on request)"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "The nurse case managers made a total of 4,049 individual contacts with 169 women in the intervention group in the year after diagnosis of breast cancer. Of these 169 subjects, 14 received no contacts from the nurse case manager because they (n = 11) or their surgeon (n = 3) refused permission to participate, but these women were included in the analyses of outcome, which were by intention to treat." Comment: No missing outcome data.
Selective reporting (reporting bias)	Low risk	Quote from reference #2: "In addition to demographic characteristics (age, education, income, race, living alone, ADL assistance, stage of cancer, attending a support group), participants were assessed for the presence of depressive symptomatology us
Other bias	Low risk	No evidence of any other bias.
Baseline outcomes similar?	Unclear risk	Comment: Primary outcomes could not be assessed at baseline since they evaluate the intervention (treatment received, receipt of appropriate therapy, evaluation process, satisfaction with decision‐making process). However, arm function results at baseline are not provided.
Baseline characteristics similar?	Low risk	Quote from reference #1: "The characteristics of the 335 participating women with breast cancer are described in Table 1. There were no significant differences between the intervention and control groups."
Protected against contamination?	Low risk	Quote from reference #1: "Randomisation was done at the level of the surgeon to reduce the chance of contamination of the control group from the case management intervention."