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

Pilot Study: Individualized Self-efficacy Coaching, Quality of Life and Compliance for Women With High-risk Early Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Patient 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland
    • Prolindo, Onkologie & Hämatologie, Team am Lindenhofspital
  • Frauenfeld, Switzerland
    • Spital Thurgau AG - Kantonsspital Frauenfeld
  • Luzern, Switzerland
    • Hirslanden Klinik St. Anna
  • St. Gallen, Switzerland
    • Tumor-und Brustzentrum ZeTuP AG St. Gallen
  • Zürich, Switzerland
    • Stadtspital Triemli
  • Saint Gallen
    • Rapperswil-Jona, Saint Gallen, Switzerland, 8640
      • Tumorzentrum ZeTuP Rapperswil-Jona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coaching group; Patient coaching	Behavioral: Patient coaching; Patients receive regular coaching to test if the coaching alters their perceived self-efficacy.
No Intervention: Control group; Control group - no additional coaching provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall quality of life	Overall quality of life is measured by the questionnaire FACT-G. Differences between the groups will be determined comparing total score. The scale ranges from 0 to 108 points. The higher the score, the better is 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	Disease-related quality of life is measured by the questionnaire FACT-B. Differences between the groups will be determined comparing total score. The scale ranges from 0 to 148 points. The higher the score, the better is 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	Active coping with the disease is measured by the questionnaire FKV-15. Differences between the groups will be determined comparing total score. The scale ranges from 15 to 75 points. The higher the score, the better the patient is coping.	The questionnaire FKV-15 is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Physical activity	Physical activity is measured by the questionnaire IPAQ. Differences between the groups will be determined comparing the level of physical activity. Analysis will be done according to the scoring manual. There is no minimum or maximum for the scale, the outcome is a continuous measure presented in Metabolic Equivalent of Task (MET)-minutes. The higher the outcome, the higher is the level of physical activity.	The questionnaire IPAQ is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Duration of hormone therapy	Duration of hormone therapy is determined by the questionnaire Compliance which consists of two items. Total duration of hormone therapy is measured in months and is compared between the groups. The questionnaire Compliance only applies to patients who receive hormone therapy.	The questionnaire Compliance is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Anxiety levels	Anxiety levels are measured by the questionnaire GAD-7. Analysis will be done according to the scoring manual. Differences between the groups will be determined comparing total score. The scale ranges from 0 to 21 points. The higher the score, the higher the level of anxiety.	The questionnaire GAD-7 is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Use of complementary medicine	Use of complementary medicine is measured by the questionnaire I-CAM-G. The number of complementary medical measures is determined descriptively and compared between the groups.	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 documented during the course of the study. The occurence of relapse is assessed by the investigator as per clinical routine and documented in the eCRF by three items.	Occurrence of relapse is assessed at the timepoint of relapse or at 7.5 months, whichever comes first.
Change of perceived self-efficacy	Change of perceived self-efficacy is measured by a specifically developed questionnaire (questionnaire SWE) and compared between the groups. An increase in perceived self-efficacy is defined as the first increase in total score of five or more points. 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 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	Change of quality of life is measured by the questionnaire FACT-G and compared between the groups. An increase in quality of life is defined as the first increase in total score of five or more points. The scale ranges from 0 to 108 points. The higher the score, the better is 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	Change of disease-related quality of life is measured by the questionnaire FACT-B and compared between the groups. An increase in disease related quality of life is defined as the first increase in total score of five or more points. The scale ranges from 0 to 148 points. The higher the score, the better is 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.
Depression	Depression is measured by the questionnaire PHQ-9. Differences between the groups will be determined comparing total score. Analysis will be done according to the scoring manual. The scale ranges from 0 to 27 points. The higher the score, the higher the level of depression.	The questionnaire PHQ-9 is collected at the timepoint of relapse or latest after 7.5 months, whichever comes first.
Use of micronutrients	Use of micronutrients is measured by the questionnaire I-CAM-G. The number of different types of micronutrients is determined descriptively and compared between the groups.	The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.

Collaborators and Investigators

• Sponsor: Stiftung Patientenkompetenz
• Collaborators: iOMEDICO AG
• Investigators: Study Director: Gerd Nagel, Professor MD, Stiftung Patientenkompetenz

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): November 22, 2018
• Study Completion (Actual): November 22, 2018

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: self-efficacy expectation
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: iOM-110393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No