Testing of the Cancer Thriving and Surviving Breast Cancer Program

NCT03651921 | Completed

• 1 other identifier: ULausanne
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Breast Cancer; Self-Management; Cancer Survivorship

Outcome Measures

Primary Outcomes (2)

• Reach of intervention assessed by ratio of eligible patients vs. participating patients

  21 weeks after baseline

• 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 Outcomes (5)

• Change in patient-reported self-efficacy assessed by SES6G

  Change from baseline to 20 weeks after baseline

• Change in patient-reported health literacy assessed by HLS-EU-Q6

  Change from baseline to 20 weeks after baseline

• Change in patient-reported symptom burden assessed by BCPT Symptom Scales

  Change from baseline to 20 weeks after baseline

• Change in patient-reported health service navigation assessed by heiQ

  Change from baseline to 20 weeks after baseline

• Change in nurse-reported self-efficacy and self-management support practices assessed by SEPSS

  Change from baseline to 30 weeks after baseline

Study Arms (2)

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.

Behavioral: CTS-BC-CH

Interventions

CTS-BC-CH 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.

Usual care and CTS-BC-CH

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female breast cancer patients or female breast care nurses.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Manuela Eicher: lead
• Swiss Cancer League: collaborator
• Lindenhofgruppe AG: collaborator

Study Sites (2)

University Hospital Basel

Basel, 4031, Switzerland

Location

University Inselspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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 DIRECTOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: August 29, 2018
• Study Start: December 12, 2017
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

CH (2)