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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

â–ª 3 items (subscale), 10 point scale

▪ Score range: 0–10 (mean scores are used); higher scores indicate higher problem rating

▪ Time frame: 1 week

â–ª Test-retest reliability 0.80

Overall level of menopausal symptoms

FACT-ES

â–ª 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

â–ª 10 items, 4 point Likert scale

â–ª 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’

â–ª Time frame: past month

▪ Test-retest kappa: 0.50–0.76

Sleep quality

GSQS

â–ª 14 items, dichotomous (yes/no) scale

▪ Score range: 0–14; higher scores indicate more sleep problems

â–ª Time frame: past month

Hot flush frequency

HFRS

â–ª 2 items (subscale); open-ended frequency scale

â–ª Score range: reported average of HF/NS per week

â–ª Time frame: past week

â–ª Test-retest reliability 0.80

Psychological distress

HADS

â–ª 14 items, 4-point Likert scale

â–ª Subscales: depression (HADS-D); anxiety (HADS-A)

▪ Score range: total score 0–42; subscale scores 0–21 higher score indicates more psychological distress

â–ª 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

â–ª 36 items, dichotomous and 3- to 6-point Likert scales

â–ª 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

â–ª Time frame: past week

▪ Cronbach’s alpha: 0.66–0.91 (mean 0.84)

â–ª For the cost-effectiveness analysis we will map the SF-36 onto the EuroQol5D to obtain utilities

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BMC Cancer

ISSN: 1471-2407

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