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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Patient coaching
Sponsored by
Stiftung Patientenkompetenz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring self-efficacy expectation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coaching group

Control group

Arm Description

Patient coaching

Control group - no additional coaching provided

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 9, 2018
Last Updated
October 25, 2022
Sponsor
Stiftung Patientenkompetenz
Collaborators
iOMEDICO AG
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1. Study Identification

Unique Protocol Identification Number
NCT03478384
Brief Title
Self-efficacy Coaching for Women With Breast Cancer
Acronym
SECOM-PSWE
Official Title
Pilot Study: Individualized Self-efficacy Coaching, Quality of Life and Compliance for Women With High-risk Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
November 22, 2018 (Actual)
Study Completion Date
November 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiftung Patientenkompetenz
Collaborators
iOMEDICO AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
self-efficacy expectation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment of patients to two groups (group A: patients receive self-efficacy coaching, group B: patients do not receive additional coaching)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coaching group
Arm Type
Experimental
Arm Description
Patient coaching
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group - no additional coaching provided
Intervention Type
Behavioral
Intervention Name(s)
Patient coaching
Intervention Description
Patients receive regular coaching to test if the coaching alters their perceived self-efficacy.
Primary Outcome Measure Information:
Title
Overall perceived self-efficacy
Description
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.
Secondary Outcome Measure Information:
Title
Overall quality of life
Description
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.
Title
Disease-related quality of life
Description
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.
Title
Active coping with the disease
Description
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.
Title
Physical activity
Description
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.
Title
Duration of hormone therapy
Description
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.
Title
Anxiety levels
Description
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.
Title
Use of complementary medicine
Description
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.
Title
Rate of Relapse
Description
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.
Title
Change of perceived self-efficacy
Description
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.
Title
Change of quality of life
Description
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.
Title
Change of disease-related quality of life
Description
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.
Title
Depression
Description
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.
Title
Use of micronutrients
Description
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 ECOG 0-2 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 Metastases 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 Male patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd Nagel, Professor MD
Organizational Affiliation
Stiftung Patientenkompetenz
Official's Role
Study Director
Facility Information:
Facility Name
Tumorzentrum ZeTuP Rapperswil-Jona
City
Rapperswil-Jona
State/Province
Saint Gallen
ZIP/Postal Code
8640
Country
Switzerland
Facility Name
Prolindo, Onkologie & Hämatologie, Team am Lindenhofspital
City
Bern
Country
Switzerland
Facility Name
Spital Thurgau AG - Kantonsspital Frauenfeld
City
Frauenfeld
Country
Switzerland
Facility Name
Hirslanden Klinik St. Anna
City
Luzern
Country
Switzerland
Facility Name
Tumor-und Brustzentrum ZeTuP AG St. Gallen
City
St. Gallen
Country
Switzerland
Facility Name
Stadtspital Triemli
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-efficacy Coaching for Women With Breast Cancer

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