Breast CancerNCT05798312
Randomized and Multicenter Study to Evaluate a Customizable Support Breast Cancer Material
A study testing Customizable support material and Non-customizable support material in people with Breast Cancer and Knowledge, Attitudes, Practice, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Knowledge, Attitudes, Practice, Patient Empowerment
- What is being tested?
- Customizable support material and Non-customizable support material
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteMexico
- Study dates
- 21 May 2021to 13 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who have already started systemic treatment for breast cancer
- Patients with medical records not available for data collection
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Zambrano Hellion
San Pedro Garza García, Nuevo León, 66278
About this study
Official title: Randomized and Multicenter Study to Evaluate the Impact of a Customizable Support Material in the Knowledge and Satisfaction of Breast Cancer Patients
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:
Read more
- 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.
Read the detailed description
In the present investigation, it is planned to carry out a prospective, multicenter study, randomized and blinded to the statistician. Patients with a recent diagnosis of CM and who are scheduled to have their first consultation in which their options will be discussed of treatment to participate in the study. To those who agree to participate and sign the informed consent, the protocol coordinator of each center will randomly assign them to the intervention group or the standard group (in a 1:1 ratio) before the appointment medical. The intervention group will receive customizable support material while the Standard group will receive a non-customizable material (Annex 2). Additionally, you will be instructed to the intervention group that the support material received can be filled with the information discussed with the medical team. The protocol coordinator will obtain sociodemographic data and clinicopathology of the medical records of the participants. After the next visit follow-up, the coordinator will apply to both groups questionnaires about the knowledge of the patient about his own disease, satisfaction with the support material received and perceived ability to participate in discussions about their treatment, and the comprehension of written materials (CHLT-6). After one month, both groups will respond knowledge questionnaires to assess long-term information retention, disease uncertainty (SF-MUIS) and satisfaction with medical information provided (EORTC-QLQ-INFO25).
- Being tested
- Customizable support material, Non-customizable support material
- Keywords
- breast cancer, patient education, written information, shared decision making, Latin America
- Medical subject headings
- Breast Neoplasms, Behavior, Patient Participation, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customizable support materialOther
Customizable support material will enable patients to identify their personal breast cancer information.
Non-customizable support materialOther
Non-customizable support material will include general breast cancer information.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive customizable support material. Receives: Other: Customizable support material |
| Standard group | Sham comparator | The standard group will receive a non-customizable support material. Receives: Other: Non-customizable support material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-month
Secondary outcomes (4)
Patient satisfaction
Assess patient satisfaction with the written information provided and the perception of their ability to actively participate in discussions about the treatment when offered a customizable educational brochure and compare it to the patients receiving a non-customizable brochure
Measured: 1-month
Comprehension
Determine if the comprehension of written materials (customizable or not customizable) is associated with the level of health literacy (Health Literacy) as measured by the Cancer Health Literacy Test - 6 (CHLT-6) instrument
Measured: 1-month
Satisfaction with medical information
To determine if satisfaction with medical information is higher when offered a customizable vs. non-customizable educational brochure as per measured by the European Organization for Research and Treatment of Cancer test Quality of Life Group information questionnaire (EORTC QLQ-INFO 25)
Measured: 1-month
Illness uncertainty
Determine if the uncertainty of the disease with the medical information is lower when offered a customizable educational brochure versus offering non-customizable material, as measured by the short form of Mishel Uncertainty Illness Scale (SF-MUIS)
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start21 May 2021
- Primary completion13 Mar 2022
- Study completion13 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will receive customizable support material while the standard group will receive a non-customizable material.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de Mama
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Cynthia Villarreal Garza, Medicos e Investigadores en la Lucha contra el Cancer de Mama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798312
- Sponsor's protocol ID
- IMAP-CM
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37317676
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized and Multicenter Study to Evaluate the Impact of a Customizable Support Material in the Knowledge and Satisfaction of Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05798312
- Acronym / sponsor ID
- IMAP-CM
- Keywords
- breast cancer, patient education, written information, shared decision making, Latin America
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de MamaUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 21 May 2021 (actual)
- Primary completion
- 13 Mar 2022 (actual)
- Study completion
- 13 Mar 2022 (actual)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the present investigation, it is planned to carry out a prospective, multicenter study, randomized and blinded to the statistician. Patients with a recent diagnosis of CM and who are scheduled to have their first consultation in which their options will be discussed of treatment to participate in the study. To those who agree to participate and sign the informed consent, the protocol coordinator of each center will randomly assign them to the intervention group or the standard group (in a 1:1 ratio) before the appointment medical. The intervention group will receive customizable support material while the Standard group will receive a non-customizable material (Annex 2). Additionally, you will be instructed to the intervention group that the support material received can be filled with the information discussed with the medical team. The protocol coordinator will obtain sociodemographic data and clinicopathology of the medical records of the participants. After the next visit follow-up, the coordinator will apply to both groups questionnaires about the knowledge of the patient about his own disease, satisfaction with the support material received and perceived ability to participate in discussions about their treatment, and the comprehension of written materials (CHLT-6). After one month, both groups will respond knowledge questionnaires to assess long-term information retention, disease uncertainty (SF-MUIS) and satisfaction with medical information provided (EORTC-QLQ-INFO25).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention group will receive customizable support material while the standard group will receive a non-customizable material.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Customizable support materialThe intervention group will receive customizable support material. |
| Standard group | Sham comparator | Other: Non-customizable support materialThe standard group will receive a non-customizable support material. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who have already started systemic treatment for breast cancer
- Patients with medical records not available for data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Customizable support materialCustomizable support material will enable patients to identify their personal breast cancer information. | Other | Intervention group |
| Non-customizable support materialNon-customizable support material will include general breast cancer information. | Other | Standard group |
Primary outcome
Knowledge
Time frame: 1-month
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.
4 secondary outcomes
Patient satisfaction
Time frame: 1-month
Comprehension
Time frame: 1-month
Satisfaction with medical information
Time frame: 1-month
Illness uncertainty
Time frame: 1-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 37317676Villarreal-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customizable support material and Non-customizable support material in people with Breast Cancer and Knowledge, Attitudes, Practice, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge (time frame: 1-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05798312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023; AzTrials last refreshed its copy on 26 Oct 2026.