Testing of the Cancer Thriving and Surviving Breast Cancer Program

Breast Neoplasm Clinical Trial

— COSS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03651921
• Other study ID #: ULausanne
• Status: Completed
• Phase: N/A
• Start date: December 12, 2017
• Est. completion date: August 15, 2019

Study information

• Verified date: August 2020
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Cancer Survivorship
• Early-Stage Breast Cancer
• Intervention
• Self-Management

Intervention

Behavioral:
• CTS-BC-CH
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.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	University Inselspital Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
Manuela Eicher	Lindenhofgruppe AG, Swiss Cancer League

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reach of intervention assessed by ratio of eligible patients vs. participating patients		21 weeks after baseline
Primary	Changes in self-management skills assessed by heiQ	Assessed by the Health Education Impact Questionnaire (heiQ)	Change from baseline to 20 weeks after baseline
Secondary	Change in patient-reported self-efficacy assessed by SES6G	Assessed by the Self-Efficacy for Managing Chronic Disease Scale (SES6G)	Change from baseline to 20 weeks after baseline
Secondary	Change in patient-reported health literacy assessed by HLS-EU-Q6	Assessed by the Health Literacy Scale Europe (HLS-EU-Q6)	Change from baseline to 20 weeks after baseline
Secondary	Change in patient-reported symptom burden assessed by BCPT Symptom Scales	Assessed by the Breast Cancer Prevention Trial (BCPT) Symptom Scales	Change from baseline to 20 weeks after baseline
Secondary	Change in patient-reported health service navigation assessed by heiQ	Assessed by a subscale of the Health Education Impact Questionnaire (heiQ)	Change from baseline to 20 weeks after baseline
Secondary	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	Change from baseline to 30 weeks after baseline