Clinical trial NCT03651921: Testing of the Cancer Thriving and Surviving Breast Cancer Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Early-Stage Breast Cancer
Self-Management
Intervention
Cancer Survivorship
Keywords: Breast Cancer
Self-Management
Cancer Survivorship
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: Swiss Cancer League
name: Lindenhofgruppe AG
First posted: 2018-08-29
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Reach of intervention assessed by ratio of eligible patients vs. participating patients
timeFrame: 21 weeks after baseline
measure: Changes in self-management skills assessed by heiQ
timeFrame: Change from baseline to 20 weeks after baseline
Secondary outcomes:
measure: Change in patient-reported self-efficacy assessed by SES6G
timeFrame: Change from baseline to 20 weeks after baseline
measure: Change in patient-reported health literacy assessed by HLS-EU-Q6
timeFrame: Change from baseline to 20 weeks after baseline
measure: Change in patient-reported symptom burden assessed by BCPT Symptom Scales
timeFrame: Change from baseline to 20 weeks after baseline
measure: Change in patient-reported health service navigation assessed by heiQ
timeFrame: Change from baseline to 20 weeks after baseline
measure: Change in nurse-reported self-efficacy and self-management support practices assessed by SEPSS
timeFrame: Change from baseline to 30 weeks after baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
city: Bern
country: Switzerland
facility: University Inselspital Bern
Study officials:
affiliation: Institute of Higher Education and Reserach in Health Care - IUFRS University of Lausanne and University Hospital of Lausanne
name: Manuela Eicher, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Swiss Cancer League Berne; Formely: Careum Stiftung, Kompetenzzentrum Patientenbildung
name: Joerg Haselbeck, Dr.
role: STUDY_DIRECTOR
affiliation: International Breast Cancer Study Group (IBCSG)
name: Karin Ribi, Dr. phil.
role: STUDY_CHAIR
affiliation: University Hospital, Basel, Switzerland
name: Corinne Urech, Dr. phil.
role: STUDY_CHAIR
affiliation: Patient Advocats for Cancer Reserach and Treamtment (Association PARCT)
name: Karin Holm
role: STUDY_CHAIR
References: