Clinical trial NCT03478384: Self-efficacy Coaching for Women With Breast Cancer
Official title: Pilot Study: Individualized Self-efficacy Coaching, Quality of Life and Compliance for Women With High-risk Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: self-efficacy expectation
Lead sponsor: Stiftung Patientenkompetenz
Sponsor class: OTHER
Collaborators: name: iOMEDICO AG
First posted: 2018-03-27
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment of patients to two groups (group A: patients receive self-efficacy coaching, group B: patients do not receive additional coaching)
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Overall perceived self-efficacy
timeFrame: The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Secondary outcomes:
measure: Overall quality of life
timeFrame: The questionnaire FACT-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
measure: Disease-related quality of life
timeFrame: The questionnaire FACT-B is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
measure: Active coping with the disease
timeFrame: The questionnaire FKV-15 is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
measure: Physical activity
timeFrame: The questionnaire IPAQ is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
measure: Duration of hormone therapy
timeFrame: The questionnaire Compliance is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
measure: Anxiety levels
timeFrame: The questionnaire GAD-7 is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
measure: Use of complementary medicine
timeFrame: The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
measure: Rate of Relapse
timeFrame: Occurrence of relapse is assessed at the timepoint of relapse or at 7.5 months, whichever comes first.
measure: Change of perceived self-efficacy
timeFrame: The questionnaire SWE is collected at baseline, after 1.5 months, 4.5 months and at the timepoint of relapse or latest after 7.5 months.
measure: Change of quality of life
timeFrame: The questionnaire FACT-G is collected at baseline, after 1.5 months, 4.5 months and at the timepoint of relapse or latest after 7.5 months.
measure: Change of disease-related quality of life
timeFrame: The questionnaire FACT-B is collected at baseline, after 1.5 months, 4.5 months and at the timepoint of relapse or latest after 7.5 months.
measure: Depression
timeFrame: The questionnaire PHQ-9 is collected at the timepoint of relapse or latest after 7.5 months, whichever comes first.
measure: Use of micronutrients
timeFrame: The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Other outcomes:
Locations:
city: Rapperswil-Jona
country: Switzerland
facility: Tumorzentrum ZeTuP Rapperswil-Jona
state: Saint Gallen
city: Bern
country: Switzerland
facility: Prolindo, Onkologie & Hämatologie, Team am Lindenhofspital
city: Frauenfeld
country: Switzerland
facility: Spital Thurgau AG - Kantonsspital Frauenfeld
city: Luzern
country: Switzerland
facility: Hirslanden Klinik St. Anna
city: St. Gallen
country: Switzerland
facility: Tumor-und Brustzentrum ZeTuP AG St. Gallen
city: Zürich
country: Switzerland
facility: Stadtspital Triemli
Study officials:
affiliation: Stiftung Patientenkompetenz
name: Gerd Nagel, Professor MD
role: STUDY_DIRECTOR
References: