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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Breast Cancer; Self Efficacy
• Intervention / Treatment: Device: Co'moon (online website to support women with AET)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Uz Leuven Campus Gasthuisberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Standard of care: a short overview of the physician on adjuvant endocrine therapy; a brochure on adjuvant endocrine therapy; a voluntary group session on adjuvant endocrine therapy and a monthly questionnaire on the patient reported outcomes
Experimental: Intervention group; Standard care with the access of to the online tool Co'moon and a monthly questionnaire on patient reported outcomes. The outcome of the questionnaires are summarized for the physician to discuss during the follow-up consultation.	Device: Co'moon (online website to support women with AET); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of Life - FACT-ES - B5 - H18	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).	monthly after two months of AET; up to 3 months
Change in self-efficacy	patient reported impact on the side effects of AET	month 3 and 6 or 7 after the start with AET
Therapy adherence	patient reported intentional or accidental forgot the medication	monthly after two months of AET; up to 3 months
Questionnaire on patients experience with the patient-physician relationship	patient reported their experience of the follow-up consultation in a 5 point Likert scale questionnaire	month 6 or 7 after the start with AET
Questionnaire on change in patient-relative communication over a period of +/- 3 months	patient reported a change in the communication of patients with their relatives in a 5 point Likert scale questionnaire	month 3 and 6 or 7 after the start with AET

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcomes	Subscales of FACT-ES combined with additional questions B5 and H18.	Monthly after two months of AET; up to 3 months
Questionnaire on the experience of the healthcare professional regarding the summary of PRO's	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.	month 6 or 7 after the start of AET
Time-spend on Co'moon	Logging of the time women spend on Co'moon	up to 3 months

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Ines Nevelsteen, Phd, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: G0F9119N

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No