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

Braeken 2013.

Methods Stratified cluster RCT ‐ with intervention group (IG) and control group (CG)
Participants Adult cancer patients receiving radiotherapy
Country: the Netherlands
Age: participants: CG: mean 63.6 years (62.5 to 64.6); IG: mean 63.2 years (62.2 to 64.3); GPs: CG: mean 53.3 years (52.5 to 54.1); IG: mean 53.3 years (52.4 to 54.1)
Sex: participants: CG: 71.4% female; IG: 72.6% female; GPs: CG: 30.2% female; IG: 36.1% female
Inclusion criteria

  1. cancer type: lung, prostate, bladder, rectum, breast, cervix, skin, endometrium, non‐Hodgkin lymphoma

  2. age ≥ 18 years

  3. no metastases

  4. provide written informed consent


Exclusion criteria

  1. receiving palliative treatment

  2. have ≤ 10 fractions of RT

  3. unable to read and speak Dutch

  4. unable to complete the questionnaires (e.g. too sick)


N randomised: N = 568; IG: n = 268 (n = 136 with baseline assessment, n = 132 without baseline assessment) CG: N = 300 (n = 144 with baseline assessment, n = 156 without baseline assessment)
N in analysis: 3 months: n = 640 (IG: n = 356, CG: n = 284); 12 months: n = 491 (IG: n = 230, CG: n = 261)
Interventions Content of screen:PSYCHOSOCIAL PROBLEMS: tool = the Dutch SIPP: 24 items: physical complaints (n = 7), psychological complaints (n = 10), social/financial problems (n = 4), and sexual problems (n = 3)
Interventionist: No interventionist for screening act (self‐reported measure)
Intervention procedure:solitary SI; participants received SIPP twice: before the first consultation with the radiotherapist and before the consultation at the end of the RT; radiotherapists checked the scores (manual provided with cut‐off scores SIPP); SIPP + judgement radiotherapist ‐> referral for psychosocial support
Conditions for implementation:

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

  2. someone has to mail the follow‐up measurements (at 3 and 12 months after baseline)

  3. training of radiotherapists in using and interpreting the SIPP


Comparative condition: Usual care group
Length of follow‐up: 12 months
Outcomes Primary outcomes

  1. number and types of referrals of people with psychosocial problems to psychosocial caregivers


Secondary outcomes

  1. participant's satisfaction with radiotherapist‐patient communication during the first consultation

  2. psychosocial distress (HADS, GHQ‐12)

  3. HRQoL (EORTC QOL‐C30)


Outcome time points: Baseline: participants on odd weeks received a pre‐measurement, participants on even weeks received no pre‐measurement; 3 months; 12 months
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not clear what method was used to generate the sequence
Allocation concealment (selection bias) Unclear risk Radiotherapists allocated to conditions, participants automatically allocated to condition of the radiotherapist. Unclear if the participant is aware of the randomisation condition of the radiotherapist/patient
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Single‐blinding: participants; radiotherapist not blinded (note: asked not to discuss the study with their colleagues of the control group)
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Outcomes were collected with mailed questionnaires
No extra person for outcome assessment aware of condition allocation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Dropout of participants from baseline to 12‐month assessment +/− 14%; equally distributed between both conditions
Selective reporting (reporting bias) Low risk Adequate
Other bias Low risk /