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Table 2 Primary and secondary outcome measures of the BREATH study

From: Rationale of the BREAst cancer e-healTH [BREATH] multicentre randomised controlled trial: An Internet-based self-management intervention to foster adjustment after curative breast cancer by decreasing distress and increasing empowerment

Questionnaires   Response format Example questions Timepoints
Primary outcome measures
Psychological distress Symptom Checklist 90 (90 items) 5 point Likert scale During the past 7 days about how much were you distressed or bothered by: T0; T1; T2; T3
  · Anxiety (10 items) * range 90–450 *Feeling fearful (anx)  
  · Agoraphobia (7 items)    
  · Depression (16 items)   * Feelings of worthlessness (depr)  
  · Somatisation (12 items)   * Numbness or tingling in parts of your body (som)  
  · Obsessive-compulsive behaviour (9 items)    
  · Interpersonal sensitivity (18 items)   * Feeling that people are unfriendly of dislike you (int.sens)  
  · Hostility (6 items)   * Nervousness or shakiness inside (anx)  
  · Sleep (3 items)    
Psychological empowerment Cancer Empowerment Questionnaire (40 items) 5 point Likert scale   T0; T1; T2; T3
  · Personal strength (19 items) * range 40-200 * I know what I am good at (pers.str)  
  · Social support (9 items)   * The people around me take me for who I am (soc.sup)  
  · Community (6 items)   * In our society people with breast cancer are considered wholly (com)  
  · Health care (6 items)   * My health care professionals are there when I need them (h.care)  
Secondary outcome measures
Anxiety and depressive states Hospital Anxiety and Depression Scale (14 items) 4 point Likert scale During the past week: T0; T1; T2; T3
  · Anxiety (7 items) * range 0-21 (subscales) * I am restless and can’t keep still (anx)  
  · Depression (7 items) * range 0-42 (total) * I feel miserable and sad (depr)  
Breast cancer- related quality of life EORTC-C30 (30 items) 4 point Likert scale During the past week: T0; T1; T2; T3
  · Functional scales (physical, role, emotional, social, and cognitive functioning - 15 items) * range 15-60 * Has your physical condition interfered with your family life? (role.func)  
  · Symptom scales (fatigue, pain, nausea/vomiting - 7 items) * range 7-28 * Have you had difficulties remembering things? (cog.func)  
  · Single symptom items (6 items) * range 6-24 7-point linear analogue scale; range 2-14 * Did pain interfere with your daily activities? (pain)  
  · Global health and global quality of life (2 items)   * How would you rate your overall quality of life during the past week?  
  EORTC-BR23 (23 items) 4 point Likert scale During the past week: T0; T1; T2; T3
  · Functional scales (body image, sexual functioning, sexual enjoyment, future perspective - 8 items) * range 8-32 * Did you find it difficult to look at yourself naked? (body.im)  
  · Symptom scales (arm symptoms, breast symptoms, systemic therapy side effects, upset by hair loss - 15 items) * range 15-60 * Did you have a swollen arm or hand? (arm.symp) During the past 4 weeks:  
    * To what extent were you interested in sex? (sex.enj)  
General distress Distress Thermometer (1 item) 11 point Likert scale   T0; T1
   * range 0-10 * Circle the number that best describes how much distress you have been experiencing in the past week including today.  
Remoralization Remoralization Scale (12 items) 4 point Likert scale   T0; T1
   * range 12-48 * I am in control of my life  
    * I take a positive attitude toward myself  
Personal control Mastery scale (7 items) 5 point Likert scale   T0; T1; T2; T3
   * range 7-35 * What happens to me in the future mostly depends on me  
Positive adjustment to cancer Positive Adjustment Questionnaire (39 items) 1-7 scale Since you found out about your illness: T0; T1; T2; T3
  · Fulfilment (9 items) * range 9-63 * My life is not limited by my illness (ful)  
  · Re-evaluation (9 items) * range 9-63 *I see life differently (re-ev)  
  · New ways of living (10 items) * range 10-70 * I can take things more in my stride (new.w)  
  · Valuing life (7 items) * range 7-49 * I value life a lot more now (val)  
Coping with the experience of cancer Impact of Event Scale 4 point Likert scale   T0; T1
  · Intrusion (7 items) * range 13-52 * I had dreams about it (intr)  
   · Avoidance (8 items) * I tried not to think about it (avoid)  
    * I tried not to talk about it (avoid)  
  Brief COPE (28 items) 4 point Likert scale   T0; T1
  · Active coping (2 items) * range 0-6 (subscales) * I’ve been taking action to try to make the situation better (act.cop)  
  · Planning (2 items)   * I’ve been learning to live with it (acc)  
  · Positive reframing (2 items)   * I’ve been giving up to attempt to cope (behav.dis)  
  · Acceptance (2 items)    
  · Humor (2 items)    
  · Religion (2 items)    
  · Using emotional support (2 items)    
  · Using instrumental support (2 items)    
  · Self-distraction (2 items)    
  · Denial (2 items)    
  · Venting (2 items)    
  · Substance use (2 items)    
  · Behavioral disengagement    
    * I’ve been criticizing myself (self-bl)  
  · (2 items)    
  · Self-blame (2 items)    
Self-efficacy Self Efficacy Scale (7 items) 4 point Likert scale   T0; T1
   * range 7-28 * Whatever I do, I cannot change my complaints  
    * I think I could positively influence my complaints  
Fear of cancer recurrence Cancer Worry Scale (8 items) 4 point Likert scale During the past month: T0; T1; T2; T3
   * range 8-32 * How often have you thought about your chance of getting cancer (again)?  
    * Have these thoughts affected your mood?  
  Cancer Acceptance Scale (2 items) 4 point Likert scale   T0; T1
   * range 2-8 * I worry about the cancer returning  
    * I am anxious about my health  
Fatigue Severity Checklist Individual Strength 7-point Likert scale   T0; T1; T2; T3
  · subscale Fatigue Severity (8 items) * range 8-56 * I feel tired  
    * I am rested  
    * Physically I feel exhausted  
Family communication ODHCF (14 items) 5 point Likert scale   T0; T1; T2; T3
  · Nuclear family (7 items) * range 7-35 (subscales) (or less if not applicable; no partner/ children/ parents/ siblings) * My partner doesn’t (nucl.fam) / parents don’t (fam.or) want me to talk about breast cancer  
  · Family of origin (7 items)   * My children (nucl.fam) / siblings (fam.or) often don’t know what to say or do, when I’m feeling down because of breast cancer.  
Illness perceptions Illness Cognition Questionnaire (18 items) 4 point Likert scale   
  · Helplessness (6 items) * range 6-24 (subscales) * My illness controls my life (help) T0; T1; T2; T3
  · Acceptance (6 items)   * I can accept my illness well (acc)  
  · Perceived benefits (6 items)   * I have learned a great deal from my illness (perc.ben)  
Personality Big Five Inventory (44 items) 5 point Likert scale I see myself as someone who: T0; T1
  · Neuroticism (8 items) * range 1-5 (subscales) * Worries a lot (neu)  
  · Extraversion (8 items)   * Is full of energy (ext)  
  · Openness to experience (10 items)   * Tends to be disorganized (con)  
  · Conscientiousness (9 items)   * Is considerate and kind to almost everyone (agr)  
  · Agreeableness (9 items)    
Health care utilization Trimbos/iMTA questionnaire for Costs associated with Psychiatric illness (TiC-P)   Since completion of primary curative breast cancer treatment (T0) / In the past four months (T1; T3) / In the past two months (T2): T0; T1; T2; T3
  · Contacts with medical or mental health care professionals (14 items) Yes/no; frequency * Did you visit a psychologist? (con)  
  · Hospitalization (1 item) Yes/no; reason Yes/no; dose and frequency * Did you use antidepressants? (med)  
  · Use of breast cancer- specific, psychiatric and other medication (8 items) Yes/no; costs * Did you take part in a breast cancer rehabilitation program? (other)  
  · Other costs (10 items)