Breast CancerSECOM-PSWENCT03478384
Self-efficacy Coaching for Women With Breast Cancer
A study testing Patient coaching in people with Breast Cancer, run by Stiftung Patientenkompetenz at 6 sites in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Patient coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 16 Mar 2018to 22 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Prolindo, Onkologie & Hämatologie, Team am Lindenhofspital
Bern
Spital Thurgau AG - Kantonsspital Frauenfeld
Frauenfeld
Hirslanden Klinik St. Anna
Lucerne
Tumorzentrum ZeTuP Rapperswil-Jona
Rapperswil-Jona, Canton of St. Gallen, 8640
Tumor-und Brustzentrum ZeTuP AG St. Gallen
Sankt Gallen
Stadtspital Triemli
Zurich
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Patient coaching
- Keywords
- self-efficacy expectation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient coachingBehavioural
Patients receive regular coaching to test if the coaching alters their perceived self-efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Coaching group | Experimental | Patient coaching Receives: Behavioral: Patient coaching |
| Control group | No intervention | Control group - no additional coaching provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start16 Mar 2018
- Primary completion22 Nov 2018
- Study completion22 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Patientenkompetenz
- Sponsor type
- University, hospital or other
- Collaborators
- iOMEDICO AG
- Responsible party
- Sponsor
- Investigators
- Gerd Nagel, Professor MD, Study director, Stiftung Patientenkompetenz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478384
- Sponsor's protocol ID
- iOM-110393
- Acronym
- SECOM-PSWE
- Status last verified
- Oct 2022
- First submitted
- 9 Mar 2018
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Individualized Self-efficacy Coaching, Quality of Life and Compliance for Women With High-risk Early Breast Cancer
- ClinicalTrials.gov ID
- NCT03478384
- Acronym / sponsor ID
- SECOM-PSWE / iOM-110393
- Conditions
- Breast Cancer
- Keywords
- self-efficacy expectation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Stiftung PatientenkompetenzUniversity, hospital or other
- Collaborators
- iOMEDICO AG
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 22 Nov 2018 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment of patients to two groups (group A: patients receive self-efficacy coaching, group B: patients do not receive additional coaching)
| Arm | Type | Receives |
|---|---|---|
| Coaching group | Experimental | Behavioral: Patient coachingPatient coaching |
| Control group | No intervention | –Control group - no additional coaching provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient coachingPatients receive regular coaching to test if the coaching alters their perceived self-efficacy. | Behavioural | Coaching group |
Primary outcome
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.
13 secondary outcomes
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.
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.
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.
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
Time frame: 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.
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.
Rate of Relapse
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
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
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
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
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
Time frame: The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd Nagel, Professor MD study director
Stiftung Patientenkompetenz
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient coaching in people with Breast Cancer, run by Stiftung Patientenkompetenz at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall perceived self-efficacy (time frame: The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.