Breast NeoplasmCOSSNCT03651921
Testing of the Cancer Thriving and Surviving Breast Cancer Program
A study testing CTS-BC-CH in people with Breast Neoplasm and Early-Stage Breast Cancer, run by Manuela Eicher at 2 sites in Switzerland.
Trial summary
The adjusted Cancer Thriving and Surviving Program (CTS) for women with breast cancer living in Switzerland (CTS-BC-CH) is a course of 7 weekly sessions of 2.5 - 3 hours led by trained peer-leaders (women with breast cancer experience). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm, Early-Stage Breast Cancer, Self-Management
- What is being tested?
- CTS-BC-CH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 12 Dec 2017to 15 Aug 2019
- 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
- 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)
Show all 23Show fewer
- 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
- 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
- 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
Who cannot join
- participation in another psycho-social intervention study
- known illiteracy (reading and writing difficulties)
- lack of language proficiency (German)
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital Basel
Basel, 4031
University Inselspital Bern
Bern, 3010
About this study
Official title: Co-creating and Testing the Reach and Effectiveness of an Integrated Peer-to-peer Self-management Program for Breast Cancer Survivors: a Pilot Study
The adjusted Cancer Thriving and Surviving Program (CTS) for women with breast cancer living in Switzerland (CTS-BC-CH) is a course of 7 weekly sessions of 2.5 - 3 hours led by trained peer-leaders (women with breast cancer experience). 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 with regard to Swiss breast cancer patients' self-efficacy and self-management.
Read the 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.
- Conditions
- Breast Neoplasm, Early-Stage Breast Cancer, Self-Management, Intervention, Cancer Survivorship
- Being tested
- CTS-BC-CH
- Keywords
- Breast Cancer, Self-Management, Cancer Survivorship
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTS-BC-CHBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual follow-up care offered in the breast centers after primary treatment by breast care team (e. g. breast care nurses, gynaecologist, oncologist, psychologist). |
| Usual care and CTS-BC-CH | Experimental | CTS-BC-CH as 7 weekly group session à 2.5 - 3 hours. Receives: Behavioral: CTS-BC-CH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach of intervention assessed by ratio of eligible patients vs. participating patients
Measured: 21 weeks after baseline
Changes in self-management skills assessed by heiQ
Assessed by the Health Education Impact Questionnaire (heiQ)
Measured: Change from baseline to 20 weeks after baseline
Secondary outcomes (5)
Change in patient-reported self-efficacy assessed by SES6G
Assessed by the Self-Efficacy for Managing Chronic Disease Scale (SES6G)
Measured: Change from baseline to 20 weeks after baseline
Change in patient-reported health literacy assessed by HLS-EU-Q6
Assessed by the Health Literacy Scale Europe (HLS-EU-Q6)
Measured: Change from baseline to 20 weeks after baseline
Change in patient-reported symptom burden assessed by BCPT Symptom Scales
Assessed by the Breast Cancer Prevention Trial (BCPT) Symptom Scales
Measured: Change from baseline to 20 weeks after baseline
Change in patient-reported health service navigation assessed by heiQ
Assessed by a subscale of the Health Education Impact Questionnaire (heiQ)
Measured: Change from baseline to 20 weeks after baseline
Change in nurse-reported self-efficacy and self-management support practices assessed by SEPSS
Assessed by the Self-Efficacy and Performance in Self-management Support (SEPSS) measure
Measured: Change from baseline to 30 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start12 Dec 2017
- Primary completion15 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manuela Eicher
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Cancer League, Lindenhofgruppe AG
- Responsible party
- Sponsor-investigator, Manuela Eicher, University of Lausanne
- Investigators
- Manuela Eicher, Prof. Dr., Study director, Institute of Higher Education and Reserach in Health Care - IUFRS University of Lausanne and University Hospital of LausanneJoerg Haselbeck, Dr., Study director, Swiss Cancer League Berne; Formely: Careum Stiftung, Kompetenzzentrum PatientenbildungKarin Ribi, Dr. phil., Study chair, International Breast Cancer Study Group (IBCSG)Corinne Urech, Dr. phil., Study chair, University Hospital, Basel, SwitzerlandKarin Holm, Study chair, Patient Advocats for Cancer Reserach and Treamtment (Association PARCT)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651921
- Sponsor's protocol ID
- ULausanne
- Acronym
- COSS
- Status last verified
- Aug 2020
- First submitted
- 1 May 2018
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-creating and Testing the Reach and Effectiveness of an Integrated Peer-to-peer Self-management Program for Breast Cancer Survivors: a Pilot Study
- ClinicalTrials.gov ID
- NCT03651921
- Acronym / sponsor ID
- COSS / ULausanne
- Conditions
- Breast Neoplasm, Early-Stage Breast Cancer, Self-Management, Intervention, Cancer Survivorship
- Keywords
- Breast Cancer, Self-Management, Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Manuela EicherUniversity, hospital or other
- Collaborators
- Swiss Cancer League, Lindenhofgruppe AG
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 29 Aug 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.
The adjusted Cancer Thriving and Surviving Program (CTS) for women with breast cancer living in Switzerland (CTS-BC-CH) is a course of 7 weekly sessions of 2.5 - 3 hours led by trained peer-leaders (women with breast cancer experience). 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 with regard to Swiss breast cancer patients' self-efficacy and self-management.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual follow-up care offered in the breast centers after primary treatment by breast care team (e. g. breast care nurses, gynaecologist, oncologist, psychologist). |
| Usual care and CTS-BC-CH | Experimental | Behavioral: CTS-BC-CHCTS-BC-CH as 7 weekly group session à 2.5 - 3 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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)
Key exclusion criteria (3 listed)
- participation in another psycho-social intervention study
- known illiteracy (reading and writing difficulties)
- lack of language proficiency (German)
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 |
|---|---|---|
| CTS-BC-CHCTS-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. | Behavioural | Usual care and CTS-BC-CH |
Primary outcome
Reach of intervention assessed by ratio of eligible patients vs. participating patients
Time frame: 21 weeks after baseline
Changes in self-management skills assessed by heiQ
Time frame: Change from baseline to 20 weeks after baseline
Assessed by the Health Education Impact Questionnaire (heiQ)
5 secondary outcomes
Change in patient-reported self-efficacy assessed by SES6G
Time frame: Change from baseline to 20 weeks after baseline
Change in patient-reported health literacy assessed by HLS-EU-Q6
Time frame: Change from baseline to 20 weeks after baseline
Change in patient-reported symptom burden assessed by BCPT Symptom Scales
Time frame: Change from baseline to 20 weeks after baseline
Change in patient-reported health service navigation assessed by heiQ
Time frame: Change from baseline to 20 weeks after baseline
Change in nurse-reported self-efficacy and self-management support practices assessed by SEPSS
Time frame: Change from baseline to 30 weeks after baseline
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 24 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Manuela Eicher, Prof. Dr. study director
Institute of Higher Education and Reserach in Health Care - IUFRS University of Lausanne and University Hospital of Lausanne
Joerg Haselbeck, Dr. study director
Swiss Cancer League Berne; Formely: Careum Stiftung, Kompetenzzentrum Patientenbildung
Karin Ribi, Dr. phil. study chair
International Breast Cancer Study Group (IBCSG)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTS-BC-CH in people with Breast Neoplasm and Early-Stage Breast Cancer, run by Manuela Eicher at 2 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 23 inclusion and 3 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 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Reach of intervention assessed by ratio of eligible patients vs. participating patients (time frame: 21 weeks after baseline). The study lists 2 primary outcomes in all. 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 24 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.