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Completed

NCT Number: NCT03651921

Testing of the Cancer Thriving and Surviving Breast Cancer Program

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel, Basel, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 21 weeks after baseline

  2. Changes in self-management skills assessed by heiQ

    Time frame: Change from baseline to 20 weeks after baseline

    Assessed by the Health Education Impact Questionnaire (heiQ)

Secondary outcomes

  1. Change in patient-reported self-efficacy assessed by SES6G

    Time frame: Change from baseline to 20 weeks after baseline

    Assessed by the Self-Efficacy for Managing Chronic Disease Scale (SES6G)

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

    Time frame: Change from baseline to 20 weeks after baseline

    Assessed by the Health Literacy Scale Europe (HLS-EU-Q6)

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

    Time frame: Change from baseline to 20 weeks after baseline

    Assessed by the Breast Cancer Prevention Trial (BCPT) Symptom Scales

  4. Change in patient-reported health service navigation assessed by heiQ

    Time frame: Change from baseline to 20 weeks after baseline

    Assessed by a subscale of the Health Education Impact Questionnaire (heiQ)

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

    Time frame: Change from baseline to 30 weeks after baseline

    Assessed by the Self-Efficacy and Performance in Self-management Support (SEPSS) measure

Sponsors and collaborators

Lead sponsor

Manuela Eicher

Other

Collaborators

  • Lindenhofgruppe AG
  • Swiss Cancer League

Registry information

Official study 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

Acronym: COSS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2018
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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