Mor 1995.

Methods	RCT; Unit of allocation: Patient; Stratified by: Unmet need status, gender
Participants	Cancer patients initiating a new course of chemotherapy. Setting / country: One of two hospital based chemotherapy clinics and eight private medical oncology practices in Rhode Island / USA Type of cancer: Any type Phase of care: Treatment, discharge, surveillance Sample size at randomisation: 257
Interventions	Short‐term case management intervention: The intervention consisted in two visits from the case manager and intervening telephone calls accompanied by individualised information about possibly needed services and their availability in the community. Specifically, it comprised an initial needs assessment, the development of an intervention plan, a follow up phase, and a termination visit. The initial home visit allowed the case manager and patient to discuss the nature and length of the intervention and their mutual expectations. The case manager conducted a clinical assessment and presented the patient with preliminary educational material focusing on needs documented in the baseline interview. A specific intervention plan was devised for each need identified in the clinical assessment. the case manager provided information on the service resources needed by the patient that were located near the patient's home. The first follow‐up contact occurred via telephone two to three days after the initial visit to reinforce the patient/case manager relationship and to address any new questions or concerns that developed. The case manager then telephoned patients at two‐week intervals to assess new unmet needs requiring intervention and to monitor the progress of previously implemented interventions. The patient could contact the case manager for assistance at any time during the follow‐up period. At the last visit, the case manager reviewed the patients' unmet need status and earlier instructions about how to solve selected types of unmet needs that might arise in the future. The case manager also presented each patient with a generic "termination" package, containing further information on community resources. A resource database was created especially for the project in order to organize information about statewide community service agencies and cancer‐specific disease and treatment information. This provided the case manager with general resource material, and allowed her to generate customised information packets for each experimental patient. Control: No intervention from the case manager.
Outcomes	Patient: Unmet needs, symptom severity, mood state, QoL Process: Use of hospital services, use of home care services
Notes	Length of follow‐up: 6 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The study was a stratified, random assignment trial. Random assignment to the Case Manager or Control groups occurred within six strata based upon unmet needs status and gender." Quote from author email message: "Among those who met BOTH eligibility criteria and who consented to the RCT, an old fashioned table of random numbers was used to randomly assigned patients into the intervention and control groups by blocks of 10 persons per block."
Allocation concealment (selection bias)	Low risk	Quotes from author email message: "This was an RCT done outside a clinical practice setting; the PI (me) is not a clinician and the intervention staff and the measurement, data collection staff were different and did not really know one another."
Blinding (performance bias and detection bias) All outcomes	High risk	Quote from author email message: "We tried to retain “Blindness” of the research data collection at the post‐tests, but often the respondents would describe a person who came to visit them. But the lack of blindness clearly did not bias the results which were negative on the a priori designated outcomes." Comment: The interviewers were supposed to be blinded, but because the patients were not blinded, they often described the care they went through so the interviewer could identify their experimental group.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: " There were no differences in the attrition pattern observed among experimental and control patients." "Attrition from follow‐up was largely attributed to patient death." Comment: Proportions of attrition at 3 and 6 months were similar between control (3 months: 16%; 6 months: 29%) and intervention groups (3 months 16%; 6 months: 28%). There are no further details on the proportions and reasons for attrition in each treatment group, but the first quote above suggests that there are no important imbalances.
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?	Unclear risk	YES: Need status UNCLEAR: Other outcomes
Baseline characteristics similar?	Unclear risk	Comment: Baseline characteristics are presented in Table 1 and are similar in the 2 treatment groups.
Protected against contamination?	Unclear risk	Comment: The allocation was not performed by clusters. There are very few details on the control group treatment. The case manager was available to intervention patients only, in their home, but no details on the setting where the case manager was based are available.