Randomized and Multicenter Study to Evaluate a Customizable Support Breast Cancer Material

NCT05798312 | Completed

• 1 other identifier: IMAP-CM
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate if a customizable support material allows to improve the knowledge about the stage and subtype of the disease, as well as the indicated treatments, in comparison with a non-customizable support material among patients with breast cancer. The main question it aims to answer is: • What is the impact of delivering a customizable support material so that patients with breast cancer know and remember the stage and subtype of their disease, as well as the indicated treatments, compared to non-customizable support material? Participants in the intervention group will be provided customizable support material while those in the standard group will receive a non-customizable material.

Conditions

Breast Cancer; Knowledge, Attitudes, Practice; Patient Empowerment; Patient Satisfaction

Keywords

breast cancer; patient education; written information; shared decision making; Latin America

Outcome Measures

Primary Outcomes (1)

• Knowledge

  Evaluate if a customizable support material allows to improve the knowledge about the stage and subtype of the disease, as well as the indicated treatments, in comparison with a non-customizable support material as measured by the knowledge questionnaire assessing patients' knowledge of their disease extension (in situ vs invasive cancer); clinical stage; estrogen, progesterone and HER2 receptor status; and treatments to which they are candidates.

  1-month

Secondary Outcomes (4)

• Patient satisfaction

  1-month

• Comprehension

  1-month

• Satisfaction with medical information

  1-month

• Illness uncertainty

  1-month

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive customizable support material.

Other: Customizable support material

Standard group

SHAM COMPARATOR

The standard group will receive a non-customizable support material.

Other: Non-customizable support material

Interventions

Customizable support material OTHER

Customizable support material will enable patients to identify their personal breast cancer information.

Intervention group

Non-customizable support material OTHER

Non-customizable support material will include general breast cancer information.

Standard group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with a recent diagnosis of primary breast cancer treated at the participant centers
• Women who will receive information about their options for the first time treatment
• Provision of informed consent to participate in the study

You may not qualify if:

• Patients who have already started systemic treatment for breast cancer
• Patients with medical records not available for data collection

Sponsors & Collaborators

• Medicos e Investigadores en la Lucha contra el Cancer de Mama: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, 66278, Mexico

Location

Related Publications (1)

• Villarreal-Garza C, Ferrigno AS, De la Garza-Ramos C, Vazquez-Juarez D, Moreno-Jaime B, Remolina-Bonilla Y, Segura-Gonzalez M, Mariscal-Ramirez I, Perazzo F, Garnica-Jaliffe G, Neciosup-Delgado S, Conde-Flores E, Mysler S, Hernandez-Ayala A, Barajas-Sanchez A, Rios Mercado MDS, Noh-Vazquez NM, Garcia-Rodriguez R, Platas A, Tamez-Salazar J, Mireles-Aguilar T, Platas A. Effect of receiving a customizable brochure on breast cancer patients' knowledge about their diagnosis and treatment: A randomized clinical trial. Cancer Med. 2023 Jul;12(14):15612-15627. doi: 10.1002/cam4.6215. Epub 2023 Jun 14.

  PMID: 37317676 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Behavior; Patient Participation; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Paticipants will receive a support material with information about breast cancer. Those in the intervention group will not know of the existence of a non-customizable material and those in the standard group will not know of the existence of a customizable material.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DSc

Model Details: The intervention group will receive customizable support material while the standard group will receive a non-customizable material.

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 4, 2023
• Study Start: May 21, 2021
• Primary Completion: March 13, 2022
• Study Completion: March 13, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)