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Completed

NCT Number: NCT05085678

Co'Moon for Supporting Breast Cancer Patients on Adjuvant Endocrine Therapy

The objective of the study is to evaluate the effect of an online tool, based on patient reported outcomes (Co'moon), on the quality of life of breast cancer patients on adjuvant endocrine therapy in the University Hospital Leuven.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Quality of Life Self Efficacy Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven campus Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

The project aims to develop and evaluate an online programme to support patients with breast cancer on adjuvant endocrine therapy in the University Hospital Leuven. The tool "Co'moon" has been developed in the first phase of the project and secondly refine in a pilot study. In the third phase a randomised controlled study investigates the effect of Co'moon in comparison with the standard of care in the University Hospital Leuven. Hereby focussing on the improvement of self-efficacy en quality of life.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

patients:

  • Women
  • Older than 18 years
  • Speaking, understanding and writing Dutch fluently
  • Mentally competent
  • Recently underwent a operation for breast cancer (invasive or in situ)
  • Takes AET for maximum two months
  • Consultation planned within 4-5 month
  • Home access of a computer with internet connection

Exclusion criteria

patients:

  • Different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (CDK) 4/6-inhibitors)
  • Metastatic disease

Inclusion criteria

health care professionals:

  • Contact with patient(s) included in the trial

Exclusion criteria

health care professionals:

  • Included in panels
  • Member of the research team

Treatment and study plan

Co'moon (online website to support women with AET)

Device

The tool contains three parts:

  • e-learning based on the brochure on adjuvant endocrine therapy (AET) in the University Hospital Leuven,
  • serious game where patients are confronted with scenes of their daily life and motivational guidelines to stimulate their self-management,
  • a patient-reported-outcome questionnaire (PROMs), reported in the patient medical file.

The tool is designed to stimulate patients self-management of their menopausal AET-related complaints and to discuss them with their health care professionals .

Other names: Class 1 medical device

Primary outcomes

  1. Change in quality of Life - FACT-ES - B5 - H18

    Time frame: monthly after two months of AET; up to 3 months

    Total score of Functional Assessment of Chronic Illness Therapy system of Quality of Life questionnaires of endocrine symptoms (FACT-ES) combined with additional questions B5 and H18. A validated questionnaire with a 5-point Likert scale and a total score of 180 (high QoL).

  2. Change in self-efficacy

    Time frame: month 3 and 6 or 7 after the start with AET

    patient reported impact on the side effects of AET

  3. Therapy adherence

    Time frame: monthly after two months of AET; up to 3 months

    patient reported intentional or accidental forgot the medication

  4. Questionnaire on patients experience with the patient-physician relationship

    Time frame: month 6 or 7 after the start with AET

    patient reported their experience of the follow-up consultation in a 5 point Likert scale questionnaire

  5. Questionnaire on change in patient-relative communication over a period of +/- 3 months

    Time frame: month 3 and 6 or 7 after the start with AET

    patient reported a change in the communication of patients with their relatives in a 5 point Likert scale questionnaire

Secondary outcomes

  1. Patient reported outcomes

    Time frame: Monthly after two months of AET; up to 3 months

    Subscales of FACT-ES combined with additional questions B5 and H18.

  2. Questionnaire on the experience of the healthcare professional regarding the summary of PRO's

    Time frame: month 6 or 7 after the start of AET

    the experience of healthcare professionals with the consultation with a 5 point Likert scale questionnaire (1 = strongly disagree, and 5 = strongly agree). The maximum score is 25.

  3. Time-spend on Co'moon

    Time frame: up to 3 months

    Logging of the time women spend on Co'moon

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 20, 2021
Registry last updated
Mar 28, 2023

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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