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. 2020 Jun 2;2020(6):CD007568. doi: 10.1002/14651858.CD007568.pub2

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
  • Psychological symptoms ‐ depression, anxiety

  • Caregiver burden

  • Autonomy – participant and carer

  • Competence – participant and carer

  • Relatedness – participant and carer


Methods for assessing outcomes:
  • 6‐item Patient‐Reported Outcomes Measurement Information System (PROMIS) short form depression measure

  • 6‐item PROMIS short form anxiety measure

  • 12‐item short form of the Zarit Burden Interview

  • Pierce measure of carers’ autonomous motivation for tending to participant needs

  • Treatment Self‐Regulation Questionnaire to assess participant autonomy for engaging in self‐care

  • Measure of competence based on the work of Lorig

  • 4‐item relatedness measure

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