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

October 25, 2022 updated by: Stiftung Patientenkompetenz

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall quality of life
Time Frame: The questionnaire FACT-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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
Time Frame: The questionnaire FACT-B is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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
Time Frame: The questionnaire FKV-15 is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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
Time Frame: The questionnaire IPAQ is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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
Time Frame: The questionnaire Compliance is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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
Time Frame: The questionnaire GAD-7 is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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
Time Frame: The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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
Time Frame: Occurrence of relapse is assessed at the timepoint of relapse or at 7.5 months, whichever comes first.
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
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 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
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 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
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.
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
Time Frame: The questionnaire PHQ-9 is collected at the timepoint of relapse or latest after 7.5 months, whichever comes first.
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
Time Frame: The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stiftung Patientenkompetenz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
iOMEDICO AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Gerd Nagel, Professor MD, Stiftung Patientenkompetenz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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