From: Decision aids for second-line palliative chemotherapy: a randomised phase II multicentre trial
 |  | Timing of measurements1 | ||
---|---|---|---|---|
Measures | Operationalisation | Baseline T1 | 1 week follow-up T2 | 8 weeks follow-up T3 |
Main outcome measures | ||||
 Well-being | ||||
  Anxiety2 | Hospital Anxiety and Depression Scale | x | x | x |
  Depression | Hospital Anxiety and Depression Scale | x | x | x |
  General health | 0-10 (worst-best imaginable) | x | x | x |
  Cancer Worries | Adapted Lerman’s Cancer Worry Scale | x | x | x |
  Health-related quality of life | EORTC QLQ-C15-PAL | x | x | x |
Additional outcome measures | ||||
 Coping | ||||
  Helplessness/hopelessness | Mental Adjustment to Cancer Scale | x | x | x |
  Fighting spirit | Mental Adjustment to Cancer Scale | x | x | x |
  Avoidance | Mental Adjustment to Cancer Scale | x | x | x |
  Perceived participation | Problem-Solving Decision Making Scale |  | x | x |
  Perceived involvement | yes/no |  | x | x |
 Information-related measures | ||||
  Amount of information | 1-7 (I received way too little-way too much information) | x | x | x |
  Undesired information | yes/no |  | x |  |
  Satisfaction with quality of information | 1-6 (not satisfied-very much satisfied) |  | x | x |
  Balanced presentation of information | 1-5 (clearly in favour of chemotherapy plus BSC - clearly in favour of BSC alone) |  | x |  |
  Evaluation of information | 1-5 (no negative experience-very negative experience) |  | x |  |
 Knowledge | ||||
  Subjective knowledge | 1-10 (extremely poor-excellent) | x | x |  |
  Objective knowledge | five statements to be judged as right or wrong |  | x |  |
  Subjective risk perception | 1-5 (very high-very low)3 |  | x |  |
 | 1-7 (much higher-much lower)4 |  | x |  |
  Objective risk perception | 0-100%5 |  | x |  |
 Decision-related measures | ||||
  Decision satisfaction-uncertainty | Decision Evaluation Scales |  | x | x |
  Decision control | Decision Evaluation Scales |  | x | x |
  Weighing pros and cons | Decision Evaluation Scales |  | x | x |
  Treatment choice | chemotherapy + BSC /BSC alone/don’t know |  | x | x |
  Strength of treatment preference | 1-5 (not strong-very strong)6 |  | x |  |
 Treatment attitudes | ||||
  Valuations | 1-10 (extremely poor-excellent) |  | x | x |
  Treatment satisfaction | 1-6 (dissatisfied-very satisfied) |  |  | x |