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

Primary Purpose

Breast Neoplasm, Early-Stage Breast Cancer, Self-Management

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
CTS-BC-CH
Sponsored by
Manuela Eicher
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasm focused on measuring Breast Cancer, Self-Management, Cancer Survivorship

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel
  • University Inselspital Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Usual care and CTS-BC-CH

Arm 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).

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

Outcomes

Primary Outcome Measures

Reach of intervention assessed by ratio of eligible patients vs. participating patients
Changes in self-management skills assessed by heiQ
Assessed by the Health Education Impact Questionnaire (heiQ)

Secondary Outcome Measures

Change in patient-reported self-efficacy assessed by SES6G
Assessed by the Self-Efficacy for Managing Chronic Disease Scale (SES6G)
Change in patient-reported health literacy assessed by HLS-EU-Q6
Assessed by the Health Literacy Scale Europe (HLS-EU-Q6)
Change in patient-reported symptom burden assessed by BCPT Symptom Scales
Assessed by the Breast Cancer Prevention Trial (BCPT) Symptom Scales
Change in patient-reported health service navigation assessed by heiQ
Assessed by a subscale of the Health Education Impact Questionnaire (heiQ)
Change in nurse-reported self-efficacy and self-management support practices assessed by SEPSS
Assessed by the Self-Efficacy and Performance in Self-management Support (SEPSS) measure

Full Information

First Posted
May 1, 2018
Last Updated
August 21, 2020
Sponsor
Manuela Eicher
Collaborators
Swiss Cancer League, Lindenhofgruppe AG
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1. Study Identification

Unique Protocol Identification Number
NCT03651921
Brief Title
Testing of the Cancer Thriving and Surviving Breast Cancer Program
Acronym
COSS
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manuela Eicher
Collaborators
Swiss Cancer League, Lindenhofgruppe AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Early-Stage Breast Cancer, Self-Management, Intervention, Cancer Survivorship
Keywords
Breast Cancer, Self-Management, Cancer Survivorship

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm 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).
Arm Title
Usual care and CTS-BC-CH
Arm Type
Experimental
Arm Description
CTS-BC-CH as 7 weekly group session à 2.5 - 3 hours.
Intervention Type
Behavioral
Intervention Name(s)
CTS-BC-CH
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reach of intervention assessed by ratio of eligible patients vs. participating patients
Time Frame
21 weeks after baseline
Title
Changes in self-management skills assessed by heiQ
Description
Assessed by the Health Education Impact Questionnaire (heiQ)
Time Frame
Change from baseline to 20 weeks after baseline
Secondary Outcome Measure Information:
Title
Change in patient-reported self-efficacy assessed by SES6G
Description
Assessed by the Self-Efficacy for Managing Chronic Disease Scale (SES6G)
Time Frame
Change from baseline to 20 weeks after baseline
Title
Change in patient-reported health literacy assessed by HLS-EU-Q6
Description
Assessed by the Health Literacy Scale Europe (HLS-EU-Q6)
Time Frame
Change from baseline to 20 weeks after baseline
Title
Change in patient-reported symptom burden assessed by BCPT Symptom Scales
Description
Assessed by the Breast Cancer Prevention Trial (BCPT) Symptom Scales
Time Frame
Change from baseline to 20 weeks after baseline
Title
Change in patient-reported health service navigation assessed by heiQ
Description
Assessed by a subscale of the Health Education Impact Questionnaire (heiQ)
Time Frame
Change from baseline to 20 weeks after baseline
Title
Change in nurse-reported self-efficacy and self-management support practices assessed by SEPSS
Description
Assessed by the Self-Efficacy and Performance in Self-management Support (SEPSS) measure
Time Frame
Change from baseline to 30 weeks after baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only female breast cancer patients or female breast care nurses.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuela Eicher, Prof. Dr.
Organizational Affiliation
Institute of Higher Education and Reserach in Health Care - IUFRS University of Lausanne and University Hospital of Lausanne
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joerg Haselbeck, Dr.
Organizational Affiliation
Swiss Cancer League Berne; Formely: Careum Stiftung, Kompetenzzentrum Patientenbildung
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Karin Ribi, Dr. phil.
Organizational Affiliation
International Breast Cancer Study Group (IBCSG)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Corinne Urech, Dr. phil.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karin Holm
Organizational Affiliation
Patient Advocats for Cancer Reserach and Treamtment (Association PARCT)
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
University Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Testing of the Cancer Thriving and Surviving Breast Cancer Program

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