Testing of the Cancer Thriving and Surviving Breast Cancer Program (COSS)
Co-creating and Testing the Reach and Effectiveness of an Integrated Peer-to-peer Self-management Program for Breast Cancer Survivors: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In 2016/17, the self-management program for cancer survivors, the Cancer Thriving and Surviving Program (CTS) was translated into German. The content of the CTS was adapted to breast cancer specific needs in three interdisciplinary workshops based on a participatory approach including active patient engagement. Additional disease-specific topics were developed and confirmed applying a multi-stakeholder e-rating approach. After a consensus meeting with the participation of breast cancer survivors, health care professional and international experts in the field of self-management, consensus on the program was reached in June 2017, resulting in the CTS-BC-CH program, i.e. a standardized manual for course leaders.
This pilot study aims to explore the reach of the CTS-BC-CH program (integrated into the clinical pathway) and to investigate its preliminary effectiveness for female Swiss breast cancer patients. The CTS-BC-CH is delivered in two breast cancer centers in in the German-speaking part of Switzerland as a group-based program with seven weekly sessions of 2.5 - 3 hours led by trained peer-leaders. Course leaders have to complete a 4-days training provided by certified master trainers. First, participants are enrolled for usual care, followed by participants who will attend the CTS-BC-CH course. Participants will complete self-reported questionnaires at three time points over a period of 6 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Basel, Switzerland, 4031
- University Hospital Basel
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Bern, Switzerland, 3010
- University Inselspital Bern
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion breast cancer patients
- female gender
- written informed consent
- aged 18 years or older
- diagnosed with an early stage breast cancer (stage 0, stage I, stage IIA, stage IIB, and stage IIIA breast cancers)
- completed primary therapy (i. e. surgery, chemotherapy and/or radiation therapy)
- at the beginning of follow-up care (including long-term endocrine therapy or targeted therapy)
- free of recurrence
- mentally able to participate, assessment of the psychological state performed by the responsible psychologist/psycho-oncologist in the breast center
- treated in the participating breast center
Inclusion course leaders
- female gender
- written informed consent
- aged 18 years or older
- diagnosed with an early stage breast cancer (stage 0, stage I, stage IIA, stage IIB, and stage IIIA breast cancers)
- > than 2 years post diagnosis
- free of recurrence
- mentally able to participate, assessment of the psychological state performed by the responsible psychologist/psycho-oncologist in the breast center
- treated in the participating breast center
- willing to participate in a course leaders training
Exclusion breast cancer patients and course leaders
- participation in another psycho-social intervention study
- known illiteracy (reading and writing difficulties)
- lack of language proficiency (German)
Inclusion breast care nurses for CTS-BC-CH implementation
- female gender
- employed at breast care center > 1 year
- participation in 4-days CTS-BC-CH course leader training
Inclusion breast care nurses for evaluating self-management support practices
- nurses: graduated with a nurses diploma > 1 year of breast cancer care experience
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Usual care
Usual follow-up care offered in the breast centers after primary treatment by breast care team (e. g. breast care nurses, gynaecologist, oncologist, psychologist).
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Experimental: Usual care and CTS-BC-CH
CTS-BC-CH as 7 weekly group session à 2.5 - 3 hours.
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CTS-BC-CH is a standardized program with 7 weekly group sessions (2.5. to 3 hours). The CTS-BC-CH focuses on building skills, sharing experiences, and support among the participants. Program elements are: Brainstorming, action plan formulation, action plan feedback, problem solving, and decision making. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Reach of intervention assessed by ratio of eligible patients vs. participating patients
Time Frame: 21 weeks after baseline
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21 weeks after baseline
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Changes in self-management skills assessed by heiQ
Time Frame: Change from baseline to 20 weeks after baseline
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Assessed by the Health Education Impact Questionnaire (heiQ)
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Change from baseline to 20 weeks after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in patient-reported self-efficacy assessed by SES6G
Time Frame: Change from baseline to 20 weeks after baseline
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Assessed by the Self-Efficacy for Managing Chronic Disease Scale (SES6G)
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Change from baseline to 20 weeks after baseline
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Change in patient-reported health literacy assessed by HLS-EU-Q6
Time Frame: Change from baseline to 20 weeks after baseline
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Assessed by the Health Literacy Scale Europe (HLS-EU-Q6)
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Change from baseline to 20 weeks after baseline
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Change in patient-reported symptom burden assessed by BCPT Symptom Scales
Time Frame: Change from baseline to 20 weeks after baseline
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Assessed by the Breast Cancer Prevention Trial (BCPT) Symptom Scales
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Change from baseline to 20 weeks after baseline
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Change in patient-reported health service navigation assessed by heiQ
Time Frame: Change from baseline to 20 weeks after baseline
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Assessed by a subscale of the Health Education Impact Questionnaire (heiQ)
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Change from baseline to 20 weeks after baseline
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Change in nurse-reported self-efficacy and self-management support practices assessed by SEPSS
Time Frame: Change from baseline to 30 weeks after baseline
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Assessed by the Self-Efficacy and Performance in Self-management Support (SEPSS) measure
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Change from baseline to 30 weeks after baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Manuela Eicher, Prof. Dr., Institute of Higher Education and Reserach in Health Care - IUFRS University of Lausanne and University Hospital of Lausanne
- Study Director: Joerg Haselbeck, Dr., Swiss Cancer League Berne; Formely: Careum Stiftung, Kompetenzzentrum Patientenbildung
- Study Chair: Karin Ribi, Dr. phil., International Breast Cancer Study Group (IBCSG)
- Study Chair: Corinne Urech, Dr. phil., University Hospital, Basel, Switzerland
- Study Chair: Karin Holm, Patient Advocats for Cancer Reserach and Treamtment (Association PARCT)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ULausanne
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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