Self-efficacy Coaching for Women With Breast Cancer

NCT ID: NCT03478384

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-16
• Study Completion Date: 2018-11-22

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Coaching group

Patient coaching

Group Type: EXPERIMENTAL

Patient coaching

Intervention Type: BEHAVIORAL

Patients receive regular coaching to test if the coaching alters their perceived self-efficacy.

Control group

Control group - no additional coaching provided

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient coaching

Patients receive regular coaching to test if the coaching alters their perceived self-efficacy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

iOMEDICO AG

INDUSTRY

Sponsor Role: collaborator

Stiftung Patientenkompetenz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerd Nagel, Professor MD

Role: STUDY_DIRECTOR

Stiftung Patientenkompetenz

Locations

Tumorzentrum ZeTuP Rapperswil-Jona

Rapperswil-Jona, Canton of St. Gallen, Switzerland

Prolindo, Onkologie & Hämatologie, Team am Lindenhofspital

Bern, , Switzerland

Spital Thurgau AG - Kantonsspital Frauenfeld

Frauenfeld, , Switzerland

Hirslanden Klinik St. Anna

Lucerne, , Switzerland

Tumor-und Brustzentrum ZeTuP AG St. Gallen

Sankt Gallen, , Switzerland

Stadtspital Triemli

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

iOM-110393

Identifier Type: -

Identifier Source: org_study_id