Self-efficacy Coaching for Women With Breast Cancer (SECOM-PSWE)

Stiftung Patientenkompetenz

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Patient coaching

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03478384

iOM-110393

Details and patient eligibility

About

This is an open, prospective, multi-center, interventional study to evaluate the benefit and efficacy of individualized self-efficacy coaching for women with high-risk early breast cancer.

In total, 6 sites will be assigned 1:1 to either the experimental arm (Group A) or the control arm (Group B). The controlled site assignment will assure a balanced site-specific QoL between both groups at baseline. All patients will be medically treated according to guidelines. The experimental Group A will in addition receive regular self-efficacy coaching.

Full description

Breast cancer represents the leading cause of cancer in women in Switzerland with around 6,000 newly diagnosed cases per year. Beside the therapy- and cancer-associated somatic illness, about one third of patients develop anxiety disorders or depression and need psychotherapeutic or psychiatric care. Women with breast cancer display the highest psychic comorbidity compared to patients with other cancer entities (40% point prevalence) .

To assist with psychological coping with the disease several psycho-oncological interventions have been established in the past decades.

Self-efficacy describes the extent or strength of one's belief in one's own ability to complete tasks and reach goals. Nagel & Schreiber have developed an individualized self-efficacy coaching for cancer patients to mobilize and strengthen the belief in one's own ability to deal with and fight the disease. The SECOM-PSWE study evaluates the impact of regular self-efficacy coaching on the perceived self-efficacy and the quality of life (QoL) in patients with early breast cancer.

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written and signed informed consent
2. Histologically confirmed early breast cancer
3. High risk patients, defined as T≥3 and/or N+ and/or G3 and/or Triple-Negative Breast Cancer (TNBC; PgR-/ER-/HER2-) at primary diagnosis
4. Eligible for systemic neo-adjuvant or adjuvant therapy
5. Age ≥ 18 years
6. ECOG 0-2
7. Expected follow-up care at site for at least 5 years
8. Expected adherence to observation and questionnaire assessment (Group A and B) as well as to study intervention (Group A)
9. Anti-cancer therapy and follow-up care according to the established guidelines
10. Fluent in written and spoken German language

Exclusion criteria

1. Not eligible for systemic neo-adjuvant or adjuvant treatment according to the established guidelines
2. Previous systemic anti-neoplastic therapy
3. Resection >R0 for adjuvant patients
4. Metastases
5. Patients who decline systemic therapy according to established guidelines for personal reasons
6. Inflammatory breast cancer, sarcomas, M. Paget
7. Presence of other primary tumors within the last 5 years, except for appropriately treated, controlled, basal-cell carcinoma and cervical cancer in situ
8. Not controlled, severe, life-threatening, or prognostic unfavorable comorbidities
9. Pregnancy, lactation
10. Indication of a severe depression/anxiety disorder at baseline (PHQ 9 Score ≥15 and/or GAD-7 Score ≥15 at baseline)
11. Participation in other (non-)interventional studies or tumor registries
12. Male patients

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Coaching group

Experimental group

Description:

Patient coaching

Treatment:

Behavioral: Patient coaching

Control group

No Intervention group

Description:

Control group - no additional coaching provided