An interventional study of Patient coaching in Breast Cancer, sponsored by Stiftung Patientenkompetenz. Completed at 6 sites in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Stiftung Patientenkompetenz · Not applicable, Interventional, and Supportive care
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.
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.
This study's enrollment of 46 is below the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Stiftung Patientenkompetenz as lead sponsor.
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Exclusion Criteria:
Patient coaching
Behavioral: Patient coaching
Control group - no additional coaching provided
Patients receive regular coaching to test if the coaching alters their perceived self-efficacy.
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.
Time frame: The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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