Self-efficacy Coaching for Women With Breast Cancer

NCT03478384 | Completed

• 1 other identifier: iOM-110393
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Keywords

self-efficacy expectation

Outcome Measures

Primary Outcomes (1)

• Overall perceived self-efficacy

  Overall perceived self-efficacy is measured by a specifically developed questionnaire (questionnaire SWE). Analysis will be descriptive, separate for each group and performed according to the analysis manual. A difference between the groups is defined as 10% difference in median between the groups. The scale ranges from 10 to 40 points. The higher the score, the higher is perceived self-efficacy of the patient.

  The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first.

Secondary Outcomes (13)

• Overall quality of life

  The questionnaire FACT-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.

• Disease-related quality of life

  The questionnaire FACT-B is collected at the timepoint of relapse or after 7.5 months, whichever comes first.

• Active coping with the disease

  The questionnaire FKV-15 is collected at the timepoint of relapse or after 7.5 months, whichever comes first.

• Physical activity

  The questionnaire IPAQ is collected at the timepoint of relapse or after 7.5 months, whichever comes first.

• Duration of hormone therapy

  The questionnaire Compliance is collected at the timepoint of relapse or after 7.5 months, whichever comes first.

Study Arms (2)

Coaching group

EXPERIMENTAL

Patient coaching

Behavioral: Patient coaching

Control group

NO INTERVENTION

Control group - no additional coaching provided

Interventions

Patient coaching BEHAVIORAL

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

Coaching group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and signed informed consent
• Histologically confirmed early breast cancer
• 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
• Eligible for systemic neo-adjuvant or adjuvant therapy
• Age ≥ 18 years
• ECOG 0-2
• Expected follow-up care at site for at least 5 years
• Expected adherence to observation and questionnaire assessment (Group A and B) as well as to study intervention (Group A)
• Anti-cancer therapy and follow-up care according to the established guidelines
• Fluent in written and spoken German language

You may not qualify if:

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

Sponsors & Collaborators

• Stiftung Patientenkompetenz: lead
• iOMEDICO AG: collaborator

Study Sites (6)

Tumorzentrum ZeTuP Rapperswil-Jona

Rapperswil-Jona, Canton of St. Gallen, 8640, Switzerland

Location

Prolindo, Onkologie & Hämatologie, Team am Lindenhofspital

Bern, Switzerland

Location

Spital Thurgau AG - Kantonsspital Frauenfeld

Frauenfeld, Switzerland

Location

Hirslanden Klinik St. Anna

Lucerne, Switzerland

Location

Tumor-und Brustzentrum ZeTuP AG St. Gallen

Sankt Gallen, Switzerland

Location

Stadtspital Triemli

Zurich, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gerd Nagel, Professor MD

  Stiftung Patientenkompetenz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment of patients to two groups (group A: patients receive self-efficacy coaching, group B: patients do not receive additional coaching)

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 27, 2018
• Study Start: March 16, 2018
• Primary Completion: November 22, 2018
• Study Completion: November 22, 2018
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (6)