search
Back to results

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

Primary Purpose

Breast Cancer, Quality of Life, Self Efficacy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Co'moon (online website to support women with AET)
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UZ Leuven campus Gasthuisberg

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).
Change in self-efficacy
patient reported impact on the side effects of AET
Therapy adherence
patient reported intentional or accidental forgot the medication
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
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

Secondary Outcome Measures

Patient reported outcomes
Subscales of FACT-ES combined with additional questions B5 and H18.
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.
Time-spend on Co'moon
Logging of the time women spend on Co'moon

Full Information

First Posted
August 13, 2021
Last Updated
March 27, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
search

1. Study Identification

Unique Protocol Identification Number
NCT05085678
Brief Title
Co'Moon for Supporting Breast Cancer Patients on Adjuvant Endocrine Therapy
Official Title
Development and Evaluation of a PROMs-based Interactive Programme as a Supporting Tool for Breast Cancer Patients Using Adjuvant Endocrine Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Quality of Life, Self Efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial with convenience sampling
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Co'moon (online website to support women with AET)
Other Intervention Name(s)
Class 1 medical device
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Change in quality of Life - FACT-ES - B5 - H18
Description
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).
Time Frame
monthly after two months of AET; up to 3 months
Title
Change in self-efficacy
Description
patient reported impact on the side effects of AET
Time Frame
month 3 and 6 or 7 after the start with AET
Title
Therapy adherence
Description
patient reported intentional or accidental forgot the medication
Time Frame
monthly after two months of AET; up to 3 months
Title
Questionnaire on patients experience with the patient-physician relationship
Description
patient reported their experience of the follow-up consultation in a 5 point Likert scale questionnaire
Time Frame
month 6 or 7 after the start with AET
Title
Questionnaire on change in patient-relative communication over a period of +/- 3 months
Description
patient reported a change in the communication of patients with their relatives in a 5 point Likert scale questionnaire
Time Frame
month 3 and 6 or 7 after the start with AET
Secondary Outcome Measure Information:
Title
Patient reported outcomes
Description
Subscales of FACT-ES combined with additional questions B5 and H18.
Time Frame
Monthly after two months of AET; up to 3 months
Title
Questionnaire on the experience of the healthcare professional regarding the summary of PRO's
Description
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.
Time Frame
month 6 or 7 after the start of AET
Title
Time-spend on Co'moon
Description
Logging of the time women spend on Co'moon
Time Frame
up to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ines Nevelsteen, Phd
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven campus Gasthuisberg
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs