Table 2

Primary and secondary outcome measures of the BREATH study
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)

van den Berg et al.

van den Berg et al. BMC Cancer 2012 12:394   doi:10.1186/1471-2407-12-394

Open Data