Outcome measures and methods of analysis for comparing between intervention and control groups
Outcome measures | Hypothesis | Methods of analysis |
Change in PAM-13 score from baseline to 12 months | Intervention increases score | Paired t-test |
Change in IES score from baseline to 12 months | Intervention decreases score | Paired t-test |
Change in GAD-7 score from baseline to 12 months | Intervention decreases score | Paired t-test |
Change in EORTC QLQ-C30 and QLQ-BR23 score from baseline to 12 months | Intervention decreases score for symptom scales and increases score for functional scales | Paired t-test |
Change in CEQ score from 6 months to 12 months | Intervention increases score | Paired t-test |
EORTC-INFO25 score | Intervention increases score | Paired t-test |
Change in heiQ score from baseline to 9 months | Intervention increases score | Paired t-test |
CEQ, Clinical Evaluation Questionnaire; EORTC, European Organisation for Research and Treatment of Cancer; GAD, General Anxiety Disorder Screener; heiQ, Health Information Questionnaire; IES, Impact of Events Scale; INFO25, Information Module; PAM, Patient Activation Measure; QLQ-BR23, Quality of Life Questionnaires—Breast-23; QLQ-C30, Quality of Life Questionnaires—Core-30.