Table 2 Primary and secondary outcome measures of the BREATH study
Questionnaires | Â | 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 | Â | 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? |  |
| Â | 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: |  |
| Â | Â | Â | * To what extent were you interested in sex? (sex.enj) | Â |
General distress | Distress Thermometer (1 item) | 11 point Likert scale | Â | T0; T1 |
| Â | Â | * range 0-10 | * Circle the number that best describes how much distress you have been experiencing in the past week including today. | Â |
Remoralization | Remoralization Scale (12 items) | 4 point Likert scale | Â | T0; T1 |
| Â | Â | * range 12-48 | * I am in control of my life | Â |
| Â | Â | Â | * I take a positive attitude toward myself | Â |
Personal control | Mastery scale (7 items) | 5 point Likert scale | Â | T0; T1; T2; T3 |
| Â | Â | * range 7-35 | * What happens to me in the future mostly depends on me | Â |
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 | Â | 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) |  |
| Â | Â | Â | * I tried not to talk about it (avoid) | Â |
| Â | Brief COPE (28 items) | 4 point Likert scale | Â | 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 | Â | T0; T1 |
| Â | Â | * range 7-28 | * Whatever I do, I cannot change my complaints | Â |
| Â | Â | Â | * I think I could positively influence my complaints | Â |
Fear of cancer recurrence | Cancer Worry Scale (8 items) | 4 point Likert scale | During the past month: | T0; T1; T2; T3 |
| Â | Â | * range 8-32 | * How often have you thought about your chance of getting cancer (again)? | Â |
| Â | Â | Â | * Have these thoughts affected your mood? | Â |
| Â | Cancer Acceptance Scale (2 items) | 4 point Likert scale | Â | T0; T1 |
| Â | Â | * range 2-8 | * I worry about the cancer returning | Â |
| Â | Â | Â | * I am anxious about my health | Â |
Fatigue Severity | Checklist Individual Strength | 7-point Likert scale | Â | T0; T1; T2; T3 |
|  | · subscale Fatigue Severity (8 items) | * range 8-56 | * I feel tired |  |
| Â | Â | Â | * I am rested | Â |
| Â | Â | Â | * Physically I feel exhausted | Â |
Family communication | ODHCF (14 items) | 5 point Likert scale | Â | 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 | Â | Â |
|  | · 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) | Â | 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) |  |  |  |