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Table 2 Study outcome measures and corresponding questionnaires

From: Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors

Variable Questionnaire Details
Primary outcomes
Hot flush/Night sweats problem rating HFRS ▪ 3 items (subscale), 10 point scale
▪ Score range: 0–10 (mean scores are used); higher scores indicate higher problem rating
▪ Time frame: 1 week
▪ Test-retest reliability 0.80
Overall level of menopausal symptoms FACT-ES ▪ 18 items, 4 point Likert scale
▪ Score range: 0–72; higher scores indicate fewer menopausal symptoms
▪ Time frame: 1 week
▪ Cronbach’s alpha: >0.80
Secondary outcomes
Sexual functioning SAQ ▪ 10 items, 4 point Likert scale
▪ Subscales: pleasure; discomfort; habit
▪ Score range: pleasure 0–18 higher scores indicate higher levels of pleasure; discomfort 0–6 lower scores indicates lower levels of discomfort; habit 0–3; single item (0 ‘less sexual activity than usual’ to 3 ‘much more sexual activity than usual’
▪ Time frame: past month
▪ Test-retest kappa: 0.50–0.76
Sleep quality GSQS ▪ 14 items, dichotomous (yes/no) scale
▪ Score range: 0–14; higher scores indicate more sleep problems
▪ Time frame: past month
Hot flush frequency HFRS ▪ 2 items (subscale); open-ended frequency scale
▪ Score range: reported average of HF/NS per week
▪ Time frame: past week
▪ Test-retest reliability 0.80
Psychological distress HADS ▪ 14 items, 4-point Likert scale
▪ Subscales: depression (HADS-D); anxiety (HADS-A)
▪ Score range: total score 0–42; subscale scores 0–21 higher score indicates more psychological distress
▪ Time frame: past week
▪ Cronbach’s alpha: HADS-D 0.67–0.90; HADS-A 0.68–0.93
Health-related quality of life SF-36 ▪ 36 items, dichotomous and 3- to 6-point Likert scales
▪ Subscales: physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality, general health perceptions
▪ Score range: 0–100; higher score indicates higher levels of functioning/well-being
▪ Time frame: past week
▪ Cronbach’s alpha: 0.66–0.91 (mean 0.84)
▪ For the cost-effectiveness analysis we will map the SF-36 onto the EuroQol5D to obtain utilities