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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) | ||||
