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Completed

NCT Number: NCT03478384

Self-efficacy Coaching for Women With 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tumorzentrum ZeTuP Rapperswil-Jona, Rapperswil-Jona, Canton of St. Gallen, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient coaching

Behavioral

Patients receive regular coaching to test if the coaching alters their perceived self-efficacy.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Stiftung Patientenkompetenz

Other

Collaborators

  • iOMEDICO AG

Registry information

Official study title

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

Acronym: SECOM-PSWE

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2018
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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