Educational Media Interventions for Cancer

(ADELANTE Trial)

Recruiting at 2 trial locations

Overseen By Michelle Tuz, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Deafness, Blindness, Psychosis, Dementia, Metastatic, others

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

Compensation: Varies

Number of Visits: 4

194 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to educate Latinx Spanish-speaking patients about radiation therapy for breast or prostate cancer. The goal is to help patients feel more informed and open to participating in cancer clinical trials. Participants will receive either an audiovisual video (Audiovisual Intervention- Cancer Clinical Trials Education) or a written brochure about cancer clinical trials and radiation therapy. The trial seeks Latinx Spanish speakers currently being treated for or recently treated for breast or prostate cancer, excluding those with conditions like deafness or dementia that might affect participation. As an unphased trial, this study offers a unique opportunity to improve educational resources for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these educational media interventions are safe?

Research has shown that educational videos and similar tools are safe and easy for patients to use. These videos enhance patients' understanding of their cancer treatments and boost their confidence. For instance, one study found that patients felt more informed and less anxious after watching a video about radiation therapy. Another study demonstrated that videos helped patients prepare for decisions about joining clinical trials.

These findings suggest that using videos to educate cancer patients is both helpful and safe. No known risks or major side effects arise from watching these educational videos, making them a reliable way to increase patient knowledge and comfort during cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these educational media interventions because they offer a fresh approach to informing cancer patients. Traditional methods often involve written brochures, but these new interventions use engaging audiovisual videos to educate patients about cancer clinical trials and radiation therapy. This innovative delivery method is not only more interactive but could also improve understanding and retention of complex information. By making educational content more accessible and easier to digest, these interventions have the potential to empower patients, leading to more informed decisions about their treatment options.

What evidence suggests that these educational media interventions could be effective for cancer patients?

Research shows that videos and other visual tools can help patients better understand and feel more positive about cancer clinical trials. In this trial, participants will receive either an audiovisual intervention or a written brochure as educational material. Studies have found that multimedia educational tools increase patients' knowledge and reduce their anxiety about clinical trials, aiding them in making more informed decisions. For those learning about radiation therapy, videos can boost confidence and understanding of the treatment. Some studies noted significant improvements in patients' knowledge of radiation side effects. These visual aids also help lower anxiety related to radiotherapy, making patients feel more prepared and comfortable. Overall, these tools seem promising in supporting cancer patients throughout their treatment journey. ^{6 7 8 9 10}

Who Is on the Research Team?

Lisa Kachnic, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for Latinx Spanish-speaking individuals with a confirmed diagnosis of non-metastatic breast or prostate cancer. They must have a Karnofsky performance status of 70 or above, indicating they are able to care for themselves. Women who can bear children need pregnancy tests as per guidelines. Participants should be planning to receive or currently undergoing curative radiation therapy and must consult using a certified interpreter.

Inclusion Criteria

My cancer has not spread beyond my prostate or breast.

I am currently being treated for breast or prostate cancer, or was recently.

I have undergone a pregnancy test as per the guidelines.

Exclusion Criteria

You have a mental illness such as psychosis or dementia.

I have received radiation therapy for areas other than my breast or prostate.

I have previously undergone radiation therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Radiation Therapy Education

Participants receive educational material (either written brochures or audiovisual intervention) to prepare for radiation therapy

1-4 weeks

2 visits (in-person)

Radiation Therapy

Participants undergo radiation therapy for breast or prostate cancer

4-9 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including clinical trial enrollment and perceptivity

8-12 weeks

1 visit (in-person)

Long-term Follow-up

Participants' medical records are reviewed to ascertain subsequent cancer clinical trial enrollment

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Audiovisual Intervention- Cancer Clinical Trials Education
• Audiovisual Intervention- Radiation Therapy Education

Trial Overview The study is testing educational media interventions designed to help Latinx patients understand radiation therapy for breast or prostate cancer and encourage informed participation in clinical trials. It includes an audiovisual education program on radiation therapy and brochures from ASTRO and NCI about cancer treatments and research studies.

How Is the Trial Designed?

Group I: Audiovisual Intervention- Radiation Therapy Education Experimental Treatment 1 Intervention

Audiovisual video will be provided to the subjects as educational material.

Group II: Audiovisual Intervention- Cancer Clinical Trials Experimental Treatment 1 Intervention

Audiovisual video will be provided to the subjects as educational material.

Group III: Written Brochure- Radiation Therapy Education Active Control 1 Intervention

Written brochures will be provided to the subjects as educational material.

Group IV: Written Brochure- Cancer Clinical Trials Active Control 1 Intervention

Written brochures will be provided to the subjects as educational material.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Varian

Collaborator

Trials

5

Recruited

380+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

A 23-minute educational video on radiation therapy significantly improved patients' knowledge about the treatment, with average correct responses increasing from 9.8 to 11.1 out of 21 questions (p<0.0001).

The video was effective across all sociodemographic groups, but particularly beneficial for patients with more than a high school education, highlighting the importance of educational tools in enhancing patient understanding before treatment consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The value of an educational video before consultation with a radiation oncologist. Matsuyama, RK., Lyckholm, LJ., Molisani, A., et al.[2021]

The AVATAR system, which allows children to watch streaming video during radiation therapy, successfully enabled 92% of pediatric patients (23 out of 25) to complete their treatment without the need for anesthesia.

This approach not only reduced the reliance on daily anesthesia but also improved the overall treatment experience for patients and their families, indicating its potential as a beneficial alternative in pediatric radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical outcomes of audiovisual-assisted therapeutic ambience in radiation therapy (AVATAR). Hiniker, SM., Bush, K., Fowler, T., et al.[2018]

A pilot study involving 300 cancer patients found that 78% of respondents felt that video information about their treatment would be helpful, indicating a strong preference for this format, especially among younger patients and those from ethnic groups.

As a result of the positive feedback, a 20-minute educational film about chemotherapy and radiotherapy has been created, and its impact on patient satisfaction, anxiety, and depression is being evaluated in a larger international trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' preferences for video cassette recorded information: effect of age, sex and ethnic group. Thomas, R., Deary, A., Kaminski, E., et al.[2019]

Patients who watched educational videos about radiation therapy reported significantly higher confidence in their knowledge of side effects (45.6% felt at least somewhat confident) compared to those who did not watch the videos (21.3%).

The videos also contributed to a decrease in anxiety for 46.8% of viewers and made 66.0% feel more comfortable attending their consultation, highlighting their effectiveness in improving patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Patient Education Videos and Knowledge of Radiation Treatment. Kumar, KA., Balazy, KE., Gutkin, PM., et al.[2021]

A study involving 92 cancer patients (26 with head and neck cancer and 66 with breast cancer) assessed the impact of a patient education video on their psychological distress, knowledge, self-efficacy, and physical symptoms, but found no significant differences between the intervention and control groups.

Despite the lack of measurable changes in outcomes, patients in the intervention group expressed high satisfaction with the video, with 90% reporting new information, suggesting that traditional study designs may not fully capture the benefits of educational materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating patient education materials about radiation therapy. Dunn, J., Steginga, SK., Rose, P., et al.[2022]

The implementation of a two-step audio-visual instruction system significantly improved parent satisfaction scores regarding their child's radiotherapy, with scores rising from 25.5 to 27.7 after the instruction (p < 0.01).

Anxiety levels among parents also decreased significantly after the instruction, with scores dropping from 54 to 50 (p = 0.004), indicating that this instructional method effectively alleviates anxiety related to the initiation of radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in satisfaction and anxiety about radiotherapy for pediatric cancer by two-step audio-visual instruction. Fuji, H., Fujibuchi, T., Tanaka, H., et al.[2023]

A systematic review of 315 studies on video-based interventions for cancer prevention and control found that these interventions have become more common over the past 30 years, with most studies using randomized controlled trial designs and focusing on screening and early detection, particularly for breast cancer.

The majority of studies (69%) reported success in achieving their objectives, but there is a need for future research to explore underrepresented topics like caregiving and palliative care, as well as to test new delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-Based Interventions for Cancer Control: A Systematic Review. Blake, KD., Thai, C., Falisi, A., et al.[2021]

The evaluation of four new audiovisual programs involving 240 cancer patients and their families showed that these programs effectively increased patients' understanding of cancer and treatment.

Patients experienced significantly lower anxiety levels compared to their families, indicating that the programs not only educate but also help reduce anxiety and improve communication with healthcare staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of audiovisual cancer programs on patients and families. Cassileth, BR., Heiberger, RM., March, V., et al.[2021]

Multimedia health education significantly improved patient self-care implementation accuracy in cancer treatment, with the experimental group achieving a remarkable increase from 24.8% to 98.5%, compared to the control group's increase from 10.9% to 79.1%.

The study involved 110 patients over nearly a year, demonstrating that multimedia resources can enhance understanding and adherence to self-care practices, which is crucial for managing side effects of radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of multimedia courses in improving self-care among patients with breast cancer undergoing radiotherapy. Yang, HF., Chang, WW., Chou, YH., et al.[2023]

A study involving 52 adult patients undergoing their first course of radiation therapy showed that site-specific animated videos significantly improved patient understanding and confidence regarding their treatment, with a mean increase in understanding and confidence score (UCS) from 9.36 to 11.92 after viewing the videos (P < .001).

The educational videos were particularly beneficial for patients with poor reading ability, who experienced a greater increase in their UCS, highlighting the effectiveness of visual aids in enhancing comprehension of complex medical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Site-Specific Education Using Digital Media to Improve Patient Understanding of the Radiotherapy Trajectory: An Interventional Study. Almerdhemah, H., Mulla, Z., Muamenah, HM., et al.[2022]

Cancer patients and their families have diverse psychological and educational needs, prompting healthcare professionals to implement a range of educational activities from one-on-one sessions to group programs across various settings.

Innovative teaching strategies, such as imagery, are being utilized to effectively address these needs, particularly during different phases of the patient's illness, highlighting the importance of tailored educational approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer patient education: what, where, and by whom? Crosson, K.[2007]

Citations

1. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-3097-2

Effectiveness of a short video-based educational intervention ... The purpose of this study was to test the effectiveness of an educational video on factors related to clinical trial participation among a healthy adolescent ...

2. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31771

Multimedia psychoeducation for patients with cancer who are ... A multimedia psychoeducation intervention improves attitudes toward clinical trials among 418 patients with cancer recruited through the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8483572/

Use of Video Education Interventions to Increase Racial ... This systematic review examined the use of video education interventions to impact BIPOC survivor participation in clinical trials.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0738399124002660

The immediate, intermediate, and long-term effectiveness ... Audiovisuals positively impacted patients' anxiety, knowledge, understanding, and physiological responses shortly after the consultation.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6558986/

Multimedia Psychoeducation for Cancer Patients Eligible ... In this study, we aimed to evaluate the effect of a multimedia psychoeducation (MP) intervention, relative to print education (PE), on patients' decision ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2360384/

A randomised controlled study of an audiovisual patient ... A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11165863/

The effectiveness of visual-based interventions on health ... We conclude that visual-based interventions, particularly the ones using videos, are effective for improving HL and the comprehension of health-related ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ecc.12424

Interventions to improve patient understanding of cancer ... This systematic review identified nine papers published between 2000 and 2013, to evaluate the effects of interventions to improve patient ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT02054715

Multimedia Psychoeducation or Print Education in ... This randomized clinical trial compares multimedia psychoeducation to print education in preparing patients with cancer for decision making about clinical ...

10. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2019.00104/full

The Impact of an Educational Video on Clinical Trial ... A randomised controlled study of an audiovisual patient information intervention on informed consent and recruitment to cancer clinical trials. Br J Cancer.