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