Testing of the Cancer Thriving and Surviving Breast Cancer Program

NCT ID: NCT03651921

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-12
• Study Completion Date: 2019-08-15

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usual care and CTS-BC-CH

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

Group Type: EXPERIMENTAL

CTS-BC-CH

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer League

OTHER

Sponsor Role: collaborator

Lindenhofgruppe AG

INDUSTRY

Sponsor Role: collaborator

Manuela Eicher

OTHER

Sponsor Role: lead

Responsible Party

Manuela Eicher

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Manuela Eicher, Prof. Dr.

Role: STUDY_DIRECTOR

Institute of Higher Education and Reserach in Health Care - IUFRS University of Lausanne and University Hospital of Lausanne

Joerg Haselbeck, Dr.

Role: STUDY_DIRECTOR

Swiss Cancer League Berne; Formely: Careum Stiftung, Kompetenzzentrum Patientenbildung

Karin Ribi, Dr. phil.

Role: STUDY_CHAIR

International Breast Cancer Study Group (IBCSG)

Corinne Urech, Dr. phil.

Role: STUDY_CHAIR

University Hospital, Basel, Switzerland

Karin Holm

Role: STUDY_CHAIR

Patient Advocats for Cancer Reserach and Treamtment (Association PARCT)

Locations

University Hospital Basel

Basel, , Switzerland

University Inselspital Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

ULausanne

Identifier Type: -

Identifier Source: org_study_id