Trials Sponsors Conditions Drugs Pricing

Conditions

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

Keywords

Breast CancerSelf-ManagementCancer 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

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-CHBehavioral

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsOnly female breast cancer patients or female breast care nurses.

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Study Sites (2)

University Hospital Basel

Basel, 4031, Switzerland

University Inselspital Bern

Bern, 3010, Switzerland

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin 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

Enrollment

39 participants (actual enrollment reported by the registry).

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

Actual (reported)

Testing of the Cancer Thriving and Surviving Breast Cancer Program

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Usual care

Usual care and CTS-BC-CH

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Usual care

Usual care and CTS-BC-CH

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations