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

NCT05085678 | Completed DMC

• 1 other identifier: G0F9119N
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Quality of Life; Self Efficacy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Patient reported outcomes

  Monthly after two months of AET; up to 3 months

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

  month 6 or 7 after the start of AET

• Time-spend on Co'moon

  up to 3 months

Study Arms (2)

Control group

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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)

Interventions

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

The tool contains three parts: 1. e-learning based on the brochure on adjuvant endocrine therapy (AET) in the University Hospital Leuven, 2. serious game where patients are confronted with scenes of their daily life and motivational guidelines to stimulate their self-management, 3. 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 .

Also known as: Class 1 medical device

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Different treatments regimes (e.g. adjuvant trial or a combination with cycline-dependent kinase (CDK) 4/6-inhibitors)
• Metastatic disease
• Contact with patient(s) included in the trial
• Included in panels
• Member of the research team

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

UZ Leuven campus Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ines Nevelsteen, Phd

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial with convenience sampling

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: October 20, 2021
• Study Start: December 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 28, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)