Educational Materials for Cancer Radiotherapy Decisions

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18, No cancer diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

51 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is being done in order to better understand and identify American Indian/Alaskan Native (AI/AN) cancer patients' attitudes and beliefs towards radiation therapy treatment plans and their willingness to pursue them.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Culturally Oriented Educational Brochure, Culturally Oriented Educational Material, Patient Education Brochure, Mayo Clinic Educational Booklet for cancer radiotherapy decisions?

Research shows that culturally targeted educational materials, like brochures, can improve understanding and attractiveness for specific cultural groups, as seen in a study with Native Hawaiians. Additionally, patient education programs have been effective in helping cancer patients understand their condition and treatment, suggesting that well-designed educational materials can support better decision-making in cancer radiotherapy. ^{1 2 3 4 5}

Is there any safety data available for culturally oriented educational materials used in cancer radiotherapy decisions?

The research does not provide specific safety data for culturally oriented educational materials, but these materials are designed to be attractive, acceptable, and useful for patients, suggesting they are safe for use in educational contexts. ^{5 6 7 8 9}

How does this treatment differ from other cancer radiotherapy treatments?

This treatment is unique because it focuses on providing culturally sensitive educational materials to help patients make informed decisions about cancer radiotherapy. Unlike standard treatments, it emphasizes understanding and addressing the specific cultural beliefs and knowledge of diverse ethnic groups, which can improve patient comprehension and engagement. ^{3 5 9 10 11}

Research Team

Samir H. Patel, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for American Indian/Alaskan Native adults with a cancer diagnosis who are recommended to undergo radiation therapy. Participants must be able to complete a survey and communicate in English well enough to give informed consent.

Inclusion Criteria

I am 18 or older and have been diagnosed with cancer.

I can complete a survey on paper by myself.

Radiation therapy is recommended for my next cancer treatment step.

Exclusion Criteria

I do not have a cancer diagnosis.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Education

Participants receive either a culturally appropriate educational brochure or the standard Mayo Clinic educational booklet

2 weeks

1 visit (in-person)

Radiation Therapy

Participants undergo radiation therapy as part of their treatment plan

90 days

Follow-up

Participants are monitored for completion of radiation therapy and changes in anxiety and perception of information

2 weeks

2 visits (virtual)

Treatment Details

Interventions

• Culturally Oriented Educational Brochure
• Mayo Clinic Educational Booklet

Trial Overview The study is testing the effectiveness of culturally tailored educational materials versus standard Mayo Clinic booklets on influencing AI/AN patients' willingness to choose radiation therapy as part of their cancer treatment.

Participant Groups

Group I: Culturally Oriented Education Experimental Treatment 2 Interventions

Subjects will receive a culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner in addition to the standard Mayo Clinic booklet

Group II: Standard of Care Mayo Clinic booklet Active Control 1 Intervention

Subjects will receive the standard Mayo Clinic educational booklet in preparation for clinically indicated radiation therapy treatment

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The Communicating the External Beam Radiation Experience (CEBRE) tool was developed to improve patient education in radiation oncology, achieving a readability level suitable for a wider audience, with a Flesch-Kincaid grade level of 5.4.

In a pilot study with 34 patients and 15 radiation oncologists, CEBRE was found to be highly usable and effective in reducing patient anxiety, with both groups rating its graphic narrative component as 'quite helpful' for understanding the radiation therapy process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating the External Beam Radiation Experience (CEBRE): Perceived Benefits of a Graphic Narrative Patient Education Tool. Arya, R., Ichikawa, T., Callender, B., et al.[2021]

This systematic review aims to evaluate the outcomes of patient education for adults taking oral anticancer agents, addressing a gap in the literature regarding safety and efficacy concerns raised by patients.

The review will analyze various factors such as content, methodology, and healthcare professionals involved, which could lead to improved safety and patient satisfaction in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. Fonda, F., Cedrone, S., Sartor, I., et al.[2023]

A review of 555 patient education materials from 14 cancer centers revealed that 91% had a reading level above the recommended grade 6, indicating that most materials are too complex for many patients to understand.

Only 14% of cancer centers provided comprehensive materials covering the full range of symptoms related to radiation therapy, highlighting a significant gap in accessible and effective patient education resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Literacy and Radiation Therapy: a Current State Assessment of Patient Education Materials. Giannopoulos, E., McBain, S., Giuliani, M., et al.[2023]

The 'Learning to Live With Cancer' education program has been successfully implemented in Sweden and expanded across Europe, demonstrating its effectiveness in helping patients and families understand the cancer experience.

A study assessing cultural adaptations of the program found only minor divergences, suggesting that the core model is broadly applicable and can effectively meet the learning needs of cancer patients from diverse cultural backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning to live with cancer in European countries. Grahn, G., Danielson, M., Ulander, K.[2019]

A participatory approach involving over 200 health providers and clients led to the creation of culturally targeted cancer education brochures for Native Hawaiians, focusing on various types of cancer.

The new brochures, featuring culturally relevant imagery and language, were found to be more appealing and comprehensible, especially to younger Hawaiians, suggesting they could effectively improve cancer education in this community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a participatory four-step protocol to develop culturally targeted cancer education brochures. Kulukulualani, M., Braun, KL., Tsark, JU.[2021]

Culture-sensitive patient information material was rated as significantly more useful immediately after distribution compared to standard translated material, with a mean difference of 3.65 in usefulness scores among 309 participants from diverse migration backgrounds.

However, there were no significant differences in the severity of depression, back pain, or quality of life between the two groups at follow-up, indicating that while cultural adaptation improves initial reception, it may not impact long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial. Hölzel, LP., Ries, Z., Kriston, L., et al.[2019]

Health literacy is essential for patients to understand medication instructions, and low literacy levels can lead to misunderstandings and poor medication adherence.

A new template using universal pictograms has been developed to create clear, language-independent medication instructions, which can help improve patient comprehension and communication about medication use and risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Visual Aids to Enhance Physician-Patient Discussions and Increase Health Literacy. Pratt, M., Searles, GE.[2022]

Culturally appropriate health education materials on medication were developed specifically for Latino and Southeast Asian populations, highlighting the importance of tailoring health information to meet diverse community needs.

The high demand for these materials indicates a significant health education gap among linguistic minority populations, emphasizing the necessity of involving community representatives in the adaptation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of culturally appropriate health education materials. Williamson, E., Stecchi, JM., Allen, BB., et al.[2022]

Patient education materials used in local health settings generally required a reading level of ninth grade, which may be too high for some patients, while a parenting booklet was accessible at a fifth-grade level.

Only 4 out of 47 materials included culturally sensitive information, highlighting a significant gap in addressing the diverse beliefs and values of over 90 ethnic and cultural groups served in these clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient education materials nurses use in community health. Wilson, FL.[2017]

A study assessing printed cancer education materials (PCEMs) for African Americans found that over half (56.2%) were culturally insensitive, particularly in their visual messaging.

To improve effectiveness, future PCEMs should incorporate culturally sensitive visuals, and the newly developed assessment tool can help ensure these materials resonate better with African American audiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cultural sensitivity in printed cancer materials. Guidry, JJ., Walker, VD.[2022]

Culturally sensitive cancer prevention education materials are essential for effectively reaching ethnically diverse populations, as most existing resources focus primarily on breast cancer and target African American communities.

There is a lack of standardized definitions and reliable measures for assessing cultural sensitivity in cancer education materials, highlighting the need for best practice guidelines that incorporate the specific cancer knowledge and beliefs of ethnic minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of culturally sensitive cancer prevention resources for ethnic minorities. Hoffman-Goetz, L., Friedman, DB.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Communicating the External Beam Radiation Experience (CEBRE): Perceived Benefits of a Graphic Narrative Patient Education Tool. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Outcomes of patient education in adult oncologic patients receiving oral anticancer agents: a systematic review protocol. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Health Literacy and Radiation Therapy: a Current State Assessment of Patient Education Materials. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Learning to live with cancer in European countries. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Using a participatory four-step protocol to develop culturally targeted cancer education brochures. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Using Visual Aids to Enhance Physician-Patient Discussions and Increase Health Literacy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The development of culturally appropriate health education materials. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Patient education materials nurses use in community health. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Assessing cultural sensitivity in printed cancer materials. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A systematic review of culturally sensitive cancer prevention resources for ethnic minorities. [2021]