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Table 2 Primary and secondary outcome measures of the SWORD-study

From: Study protocol of the SWORD-study: a randomised controlled trial comparing combined online and face-to-face cognitive behaviour therapy versus treatment as usual in managing fear of cancer recurrence

Primary outcome
  Questionnaire Response format Example question Timepoints
Fear of cancer recurrence Cancer Worry Scale (CWS) (8 items) 4-point Likert scale *range 8 - 32 During the past month: “How often have you thought about your chances of getting cancer (again)?” Screening T0;T1;T2;T3
Secondary outcomes
Dimensions of FCR Fear of Cancer Recurrence Inventory (42-items) 5-point Likert scale “How many times per day do you spend thinking about the possible chance of recurrence?” “I am worried or anxious about a possible chance of recurrence.” “I try to replace this thought with a more pleasant one.” T0;T1;T2;T3
Subscales:
• Triggers (8 items) −0 - 32
• Severity (9 items) −0 - 36
• Psychological distress (4 items) −0 - 16
• Functional impairment (6 items) −0 - 24
• Coping strategies (9-items) −0 - 36
• Insight (3 items) −0 - 12
• Reassurance Seeking (3 items) −0 - 12
Cancer related quality of life EORTC-QLC C30 (30 items) Subscales: 4-point Likert scale “Were you limited in pursuing your hobbies or other leisure time activities?” “How would you rate your overall health during the past week? (Global health)” T0;T1;T2;T3
• Five functional scales (15 items) −15 - 60
• Three symptom scales (7 items) −7 - 28
• Single symptom items (6 items) −6 - 24
• Global health & quality of life scales (2 items) −2 - 14
Cancer specific quality of life: Breast cancer EORTC-BR23 (23 items) Four functional scales (8 items) −8 - 32 “Have you felt physically less attractive as a result of your disease or treatment?” T0;T1;T2;T3
• Four symptom scales (15 items) −15 - 60
Cancer specific quality of life: Prostate cancer EORTC-PR25 (25 items)   “Have you had difficulty going out of the house because you needed to be close to a toilet?” T0;T1;T2;T3
• Two functional scales (6 items) −6 - 24
• Four symptom scales (19 items) −19 - 76
Cancer specific quality of life: Colorectal cancer EORTC-CR38 (38 items) Two functional scales (7 items) −7 - 28 “During past week, where you bothered by gas (flatulence)?” T0;T1;T2;T3
• Seven symptom scales (28 items) −26 - 104
• Three single symptom items −1 - 4
Satisfaction with life Satisfaction With Life Scale (5-items) 7-point Likert scale *5 - 35 “In general, I am satisfied with life.” T0;T1;T2;T3
Distress Hospital Anxiety and Depression Scale (14 items) Subscales 4-point Likert scale *0 - 42 “I feel tense or wound up” “I feel as if I am slowed down” T0;T1;T2;T3
• Anxiety (7 items) −0 - 21
• Depression (7 items) −0 - 21
  Distress thermometer (1 item) Problem List (47 items) VAS *0 - 10 *0 - 47 “Circle the number (0-10) that best describes how much distress you have been experiencing in the past week.” T0;T1;T2;T3
Fatigue severity Checklist Individual Strength – Fatigue Severity subscale (8 items) 7-point Likert scale *8 - 56 “I feel tired” “I am rested” T0;T1;T2;T3
Optimism Life orientation Test (LOT) (12 items) 5-point likert scale *0 - 32 “In uncertain times, I usually expect the best.” T0;T1;T2;T3
Body vigilance Body Vigilance Scale (4-items) VAS scale *0 - 10 item 1-3 *0 - 15 item 4 “I am very sensitive to changes in my internal bodily sensations” T0;T1;T2;T3
Coping with the experience of cancer Impact of Events Scale (15 items) Subscales 4-point Likert scale *0 - 35 *0 - 40 “Any reminder brought back feelings about it.” (intrusion) T0;T1;T2;T3
• Intrusion (7 items)
• Avoidance (8 items)
Perceived social support Social Support List – Dissatisfaction scale (34-item) 4-point likert scale *34 - 102 What is your opinion about the extent to which people…: “Drop in for a pleasant visit?” T0;T1;T2;T3
Personality Big Five Inventory (44 items) Subscales Neuroticism (8 items) 5-point Likert scale I see myself as someone: “Who… can be somewhat careless.” (conscientiousness) “Who… Is sometimes shy, inhibited.” (extraversion) T0
• Extraversion (8 items)
• Openness (10 items)
• Conscientiousness (9 items)
• Agreeableness (9 items)
Health care use EQ-5D (5 items) EQ-5D thermometer 4-point Likert scale VAS Scale (0 - 100) “Please indicate which statement best describes your own health state today.” T0;T1;T2;T3
  TIC-P – part I Open ended questions In the past 4 weeks did you “how often did you visit the general practitioner?” T0
  Custom made cost diaries Open ended questions During the specified period: ‘How often did you consult the general practitioner and why?’ Between T0-T1 T1-T2 T2-T3 T3-T4