Traeger 2015.
Study characteristics | ||
Methods |
Setting: Massachusetts, USA Recruitment: eligible participants were 18 years or older; had a diagnosis of stage I‐III breast, lung, or colorectal cancer and were scheduled to start chemotherapy; and were able to respond to questionnaires in English. Participants were recruited by a study co‐ordinator during their first chemotherapy visit. They were recruited consecutively until target enrolment was reached Randomisation: by a clinical trials office (1:1 allocation sequence) with stratification by tumour type |
|
Participants | 120 participants initiating chemotherapy for non‐metastatic disease (60 breast cancer; 30 colorectal cancer; 30 lung cancer) | |
Interventions | Intervention: provocative telephone‐based nursing guidance and support during first 2 chemotherapy cycles. Interventionists had a brief outline to structure calls but were encouraged to complete them according to clinical judgement to reflect participant‐centred practice. Two calls were provided during the first week after first chemotherapy administration, and 2 in the first week after the second cycle. Calls lasted around 15 minutes | |
Outcomes |
Methods for assessing outcomes:
|
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Dana Faber/Harvard Cancer Center Quality Assurance Officer for clinical trials randomly assigned participants |
Allocation concealment (selection bias) | Unclear risk | For control participants, the nurse practitioner was not notified of study enrolment or group assignment |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | No details |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Study retention rate 97.5% |
Selective reporting (reporting bias) | Low risk | Balanced reporting of all measures |
Other bias | High risk | If the electronic health record showed a documented in‐person oncology visit during the intervention delivery window, the in‐person visit was counted as a completed call |