The BREATH study: Online self-management to facilitate adjustment after curative breast cancer.

Development and (cost)effectiveness of a non-guided web-based psychological self-management intervention to facilitate recovery for breast cancer patients who completed primary curative treatment.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28971

Enrollment

170

Registered

2011-06-06

Start date

2010-08-16

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer, mamma carcinoma, borstkanker, Internet, web-based intervention, self-management

Interventions

The non-guided self-management BREATH intervention focuses on information and treatment of psychological problems (such as anxiety and depression), emotional processing issues, social problems (such a

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically proven malignancy of the breast; 2. Breast cancer is treated with curative intent surgery and adjuvant chemotherapy and/or radiotherapy; 3. Patients with direct access to a computer with internet connection and some skill on the Internet; 4. A good command of Dutch language.

Exclusion criteria

Exclusion criteria: 1. Patients treated only with surgery; 2. Patients with metastatic breast carcinoma; 3. Previous malignancy except adequately treated cervix carcinoma in situ and treated basal cell carcinoma of the skin; 4. Psychiatric problems that interfere with adherence to the study.

Design outcomes

Primary

Measure	Time frame
Psychological distress (SCL-90 ; Arrindell, 2003) and empowerment (Cancer Empowerment Questionnaire; Van den Berg, 2010). 1. Arrindell WA, Ettema JHM. SCL-90: Handleiding bij een multidimensionele psychopathologie-indicator [SCL-90: Manual for a multifaceted measure of psychopathology]. Lisse, Swets & Zeitlinger, 2003; 2. Van den Berg SW, Gielissen M, Prins JP. Validation of an empowerment questionnaire in breast cancer survivors. Meeting abstract 12th World Congress of Psycho-Oncology, May 2010.	—

Measure

Time frame

Psychological distress (SCL-90 ; Arrindell, 2003) and empowerment (Cancer Empowerment Questionnaire; Van den Berg, 2010). 1. Arrindell WA, Ettema JHM. SCL-90: Handleiding bij een multidimensionele psychopathologie-indicator [SCL-90: Manual for a multifaceted measure of psychopathology]. Lisse, Swets & Zeitlinger, 2003; 2. Van den Berg SW, Gielissen M, Prins JP. Validation of an empowerment questionnaire in breast cancer survivors. Meeting abstract 12th World Congress of Psycho-Oncology, May 2010.

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Secondary

Measure	Time frame
1. Quality of life generally (EORTC QLQ C30) and specifically for breast cancer patients (BR23); 2. Anxiety and depression (HADS); 3. Remoralization (RS); 4. Perceived control (Mastery-scale); 5. Positive adjustment (PAQ); 6. Personality (BFI); 7. Coping (Cope); 8. Impact of events (IES); 9. Illness cognitions (ICQ); 10. Fear of cancer recurrence (CWS); 11. Openness to discuss cancer (ODHCF); 12. Self-efficacly (SE-28); 13. Fatigue (CIS-fatigue). For patients in the experimental group, also medical disease-specific data are collected and technical data on the use of the web-based intervention, in addition to the standardized questionnaires.	—

Measure

Time frame

1. Quality of life generally (EORTC QLQ C30) and specifically for breast cancer patients (BR23); 2. Anxiety and depression (HADS); 3. Remoralization (RS); 4. Perceived control (Mastery-scale); 5. Positive adjustment (PAQ); 6. Personality (BFI); 7. Coping (Cope); 8. Impact of events (IES); 9. Illness cognitions (ICQ); 10. Fear of cancer recurrence (CWS); 11. Openness to discuss cancer (ODHCF); 12. Self-efficacly (SE-28); 13. Fatigue (CIS-fatigue). For patients in the experimental group, also medical disease-specific data are collected and technical data on the use of the web-based intervention, in addition to the standardized questionnaires.

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Contacts

Public ContactS.W. Berg, van den

POBox 9101

s.vandenberg@mps.umcn.nl+31 (0)24 3617022

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)