Badr 2015.
| Study characteristics | ||
| Methods |
Setting: Mount Sinai Hospital, New York, USA Recruitment: eligible participants had advanced lung cancer (LC), were within 1 month of treatment initiation, were spending more than 50% of their time out of bed each day, and had a partner (or other close family member) whom they identified as their primary carer. Participants and carers had to be at least 18 years old and able to read and understand English, and had to provide informed consent Randomisation: 2‐arm RCT |
|
| Participants | 39 lung cancer participants and their partners | |
| Interventions | Participants and their partners were randomised to receive usual medical care or a psychosocial intervention Psychosocial intervention: participants and carers in the intervention group received a manual, covering the topics of self‐care, stress and coping, symptom management, effective communication, problem‐solving, and maintaining and enhancing relationships. In addition, they participated in 6 × weekly 60‐minute telephone counselling sessions Usual medical care: primary palliative care was provided by the participant’s medical oncologist, including basic management of pain and other symptoms, including depression and anxiety, with referral to outpatient supportive oncology practice if required Interventionist: trained interventionist with a master’s degree in mental health counselling |
|
| Outcomes |
Methods for assessing outcomes:
|
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | The generation of random sequence is not described |
| Allocation concealment (selection bias) | Unclear risk | Not stated |
| Blinding (performance bias and detection bias) All outcomes | High risk | Owing to the nature of the intervention, study participants and interveners were not blinded. It is unclear who collected the data and by what method |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up < 20%; similar reasons between groups |
| Selective reporting (reporting bias) | Low risk | There appears to be no selective reporting of outcomes |
| Other bias | Unclear risk | Participants received $20 gift cards on completing surveys |