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. 2019 Mar 25;2019(3):CD012387. doi: 10.1002/14651858.CD012387.pub2

Nimako 2015.

Methods RCT ‐ with intervention group (IG), usual care control group (UCG), and attention control group (ACG)
Participants Patients of all ages with a diagnosis of a thoracic cancer who had recently completed treatment.
Country: UK
Age: IG: mean 64.6 years; ACG: mean 64.7 years; UCG: 62.9 years
Sex: IG: 44% female; ACG: 45% female; UCG: 46% female
Inclusion criteria
  1. attending the Royal Marsden Hospital

  2. diagnosis of a thoracic cancer (NSCLC, SCLC, and mesothelioma)

  3. able to understand written and spoken English

  4. recently completed treatment


Exclusion criteria
  1. a plan to commence treatment (chemotherapy, targeted therapies, radiotherapy, surgery) within 6 weeks,

  2. taking part in any other studies that required the completion of a QoL questionnaire

  3. had received any anticancer treatment (chemotherapy, radiotherapy, surgery, or targeted therapies) within the previous 3 weeks

  4. had any ongoing toxicities from their treatment that had not been stabilised (i.e. required intervention within the last 7 days)


N randomised: N = 138; IG: n = 45; ACG: n = 47; UCG: n = 46
N in analysis
Baseline measures: N = 138; IG: n = 45; ACG: n = 47; UCG: n = 46
6 weeks' measures: N = 131; IG: n = 42; ACG: n = 45; UCG: n = 44
Interventions Content of screen:HRQoL: tool = EORTC QLQ‐C30: 5 functional scales, 9 symptom scales, and 2 General Health and QoL items, no total score can be computed
Interventionist: No interventionist for screening act, self‐completion of screening tool
Intervention procedure:Solitary SI
  1. IG: participants completed EORTC QLQ‐C30 and EORTC QLQ‐LC13 on paper in waiting room before clinic visit; this questionnaire was given to the reviewing doctor. The doctor provided feedback to the participant and conducted the consultation with the aid of the questionnaire

  2. attention CG: participants also completed the EORTC QLQ‐C30 on paper and LC13 in waiting room before clinic visit; the questionnaire was filed and not shared with the doctor


Conditions for implementation:
  1. a system/person is needed to deliver and collect questionnaires and to control data management

  2. training of reviewing doctors in the use and interpretation of the questionnaire


Comparative condition: Usual care group
Length of follow‐up: 6 weeks
Outcomes Primary outcomes
  1. global Health at 6 weeks: General Health Status (item from EORTC QLQ‐C30)


Secondary outcomes
  1. changes in QoL from baseline to 6 weeks between intervention and control groups

  2. improvement in 5 functional scales of EORTC QLQ‐C30

  3. improvement in symptom scales of EORTC QLQ‐LC13

  4. number of QoL issues identified at baseline

  5. number of management actions at baseline

  6. number of contacts with healthcare professionals outside clinic during study


Outcome time points: baseline and 6 weeks after baseline
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Electronic randomisation is mentioned, however exact method of sequence generation is unclear
Allocation concealment (selection bias) Unclear risk Not mentioned who allocated the participants to the 3 conditions and how this was done, unclear if allocation was concealed
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Participants and doctors were not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk QoL assessments: completed on paper and over the phone, unclear if the telephone assessor was blinded
QoL issues identification and management: outcome assessment by the principal investigator based on the record chart completed by the unblinded doctor and the GP letter
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcome data appear to be complete, dropout from baseline to 6 weeks' postbaseline +/− 7%
Selective reporting (reporting bias) High risk Only data on the Global Health question of the EORTC QLQ‐C30 was used/reported for control group while whole questionnaire was administered by participants in the control group
Other bias Low risk /