Given 2002.

Methods	RCT; Unit of allocation: Patient‐caregiver dyad; Stratified by: Cancer site
Participants	Patients with a diagnosis of a solid tumour undergoing a first course of chemotherapy and having a family caregiver who agreed to participate in the study. Setting / country: Six outpatient cancer treatment sites in Michigan / USA Type of cancer: Any type Phase of care: Treatment Sample size at randomisation: 237
Interventions	Nursing intervention plus conventional care: The nursing intervention was based on a cognitive‐behavioural framework that focused on problem solving, information acquisition, self‐care management for symptoms, and emotional and social support for patients. It consisted of 10 contacts, 6 in person and 4 via telephone, occurring at 2‐week intervals over a 20‐week period.  In‐person meetings with the patient‐caregiver dyad lasted approximately one hour; telephone encounters lasted 20 minutes, on average, and were conducted independently for the patient and caregiver. Patients were queried at each contact regarding the severity and impact on dimensions of their quality of life of 15 symptoms, as well as functional limitations and emotional distress. Severity of the symptoms was rated by patients on a 10‐point scale ranging from 1 (barely noticeable), to a 10 (worst possible). When severity was rated as 5 or higher, that symptom was transferred to the plan of care (using a computer assisted protocol) for problem resolution. If patients reported that a symptom reached a threshold of 3 or higher on a 5‐point scale for any one of the quality‐of‐life dimensions, it was transferred to the plan of care. Interventions were tailored to the patients' problems and categorised as teaching, counselling and support, coordination, and communication. At each intervention encounter, the nurse would also ask the patient to evaluate the efficacy of the intervention strategies identified previously and the status of the problem resolution. Intervention strategies then were modified, changed, or deleted depending on the result. Revisions to the plan of care were made as necessary to resolve the problem. Interventions were tailored to the patients problems and categorised as teaching, counselling and support, coordination, and communication. Each intervention nurse had the same cancer‐nursing intervention software loaded onto a laptop computer. This software housed problem‐specific, evidence‐based intervention strategies that the nurse and patient could mutually select for the patient to implement on his or her own behalf to move the problem toward resolution. Every screen for each patient‐caregiver dyad was reviewed by the nurse coordinator on a monthly basis. Control: Conventional care
Outcomes	Patient: Symptoms, QoL ‐ functioning
Notes	Length of follow‐up: 5 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote from author email: "This was a minimization approach (Taves 1986)  where patients were allocated by site of cancer by location in order to balance the design  between the experimental and control group. Persons in the settings (oncologists and nurses ) were not aware of the group assignments." Comment: The minimisation approach is an approach recognised as valid for generating the allocation sequence.
Allocation concealment (selection bias)	Low risk	Quote from author email: "Trial nurses at the respective sites informed prospective patient participants, obtained their informed consent and forwarded their information to a central location where trained interviewers contacted participants by telephone to collect data."
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote from author email message: "Further, interviewers were unaware of the allocation (at intake because allocation had not occurred) and later because no information as to study arm was provided them and they had no access to this information."
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote from ref #2: "Retention at 10 weeks by site or stage of cancer did not differ between patients in the experimental and control groups." Quote from ref #2: "Comparing score at baseline, no statistically significant differences were found by group for those lost and retained at 20 weeks. However, although not significant, some differences were noted." Quote from ref #2: "Because of differences in the number of observations after 10 and 20 weeks owing to death or withdrawal, a repeated measures analysis of variance design was not used. Instead, a GLM was used to test separate group effects at 10 and 20 weeks. By testing for group effects at both 10 and 20 weeks, we could determine whether and when the intervention might affect symptom severity." Comment: Proportion of missing data is equal in experimental and controls groups (27%). Reasons for attrition were, however, not explained in the article. No imputation was used.
Selective reporting (reporting bias)	Low risk	All outcomes in the methods section are reported in the results section.
Other bias	Low risk	No evidence of other bias.
Baseline outcomes similar?	Low risk	Quote from ref #1: "The baseline measure for each dependent variable was entered as a covariate, as was the site of cancer by group interaction term." Quote from ref #2: "Tests for differences in site and stage of cancer, severity, number of symptoms, total number of supportive medications, and between community and comprehensive sites revealed no differences in symptom severity at baseline at the 5% level of significance."
Baseline characteristics similar?	Low risk	Quote from ref #1: "The tests for equivalency at baseline between the experimental and control groups regarding demographic, independent, and dependent variables are presented in Table 1. No significant differences between the groups at baseline were found."
Protected against contamination?	High risk	Quote from ref#2: Thus 237 patients and their family caregivers completed the intake interview and were randomly assigned to either the 10‐contact, 20‐week experimental intervention or to conventional care. Conventional care was the usual practice for each setting. Comment: Patients from each of the groups were present in each setting and were not stratified by practitioner. Even if the family caregivers were randomised, they were not the one providing the intervention, so a risk of contamination between practitioners was possible.