Pilot Study: Individualized Self-efficacy Coaching, Quality of Life and Compliance for Women With High-risk Early Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Stiftung Patientenkompetenz
- Enrollment
- 46
- Locations
- 6
- Primary Endpoint
- Overall perceived self-efficacy
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •Not eligible for systemic neo-adjuvant or adjuvant treatment according to the established guidelines
- •Previous systemic anti-neoplastic therapy
- •Resection \>R0 for adjuvant patients
- •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
Outcomes
Primary Outcomes
Overall perceived self-efficacy
Time Frame: The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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.
Secondary Outcomes
- 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.)
- Anxiety levels(The questionnaire GAD-7 is collected at the timepoint of relapse or after 7.5 months, whichever comes first.)
- Change of perceived self-efficacy(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.)
- Change of quality of life(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.)
- Change of disease-related quality of life(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.)
- Use of complementary medicine(The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.)
- Rate of Relapse(Occurrence of relapse is assessed at the timepoint of relapse or at 7.5 months, whichever comes first.)
- Use of micronutrients(The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.)
- Depression(The questionnaire PHQ-9 is collected at the timepoint of relapse or latest after 7.5 months, whichever comes first.)