Testing of the Cancer Thriving and Surviving Breast Cancer Program (COSS)

Manuela Eicher

Status: Completed

Conditions: Cancer Survivorship; Breast Neoplasm; Intervention; Self-Management; Early-Stage Breast Cancer

Treatments: Behavioral: CTS-BC-CH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03651921

ULausanne

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Usual care

No Intervention group

Description:

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 group

Description:

CTS-BC-CH as 7 weekly group session à 2.5 - 3 hours.

Treatment:

Behavioral: CTS-BC-CH