Online Peri-operative Education for Head and Neck Cancer Surgery

No longer recruiting at 1 trial location

Overseen By Jason Rich, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Under 18, No internet, Non-English

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether an online platform called CareOrbit can help patients and their caregivers feel more prepared and satisfied before and after surgery for head and neck cancers. Researchers aim to determine if it reduces hospital readmissions and unplanned doctor visits. Participants will receive access to an online account with educational resources, which they can share with up to three caregivers. Suitable candidates have had or are about to undergo major surgeries like free flap surgery or total laryngectomy, have internet access, and speak English. As an unphased trial, this study provides a unique opportunity for patients to contribute to innovative solutions that could enhance surgical care experiences.

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 prior data suggests that this online education platform is safe for patients and caregivers?

Research has shown that CareOrbit, an online education tool for head and neck cancer patients, improves understanding of their care without causing side effects. Studies suggest it enhances patient education and may even support recovery. As an educational tool, not a medical treatment, it lacks specific information on negative effects. This trial is in a "Not Applicable" phase, focusing on the platform's usefulness rather than safety, unlike a drug trial. Therefore, participants should have minimal safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CareOrbit program because it offers a unique approach to managing post-operative care for head and neck cancer surgery patients. Unlike traditional care that relies heavily on in-person education and follow-ups, CareOrbit leverages online tools to provide continuous support and education to both patients and their caregivers. This method allows for greater involvement of caregivers, who can access personalized information and updates through the internet, enhancing the overall care experience. By integrating technology into the recovery process, CareOrbit aims to improve patient outcomes and streamline communication between patients, caregivers, and healthcare providers.

What evidence suggests that the CareOrbit platform is effective for improving peri-operative education for head and neck cancer surgery?

Research has shown that preoperative education programs like CareOrbit can improve recovery for head and neck cancer patients. In this trial, participants will join one of two groups: "CareOrbit - Patients" or "CareOrbit - Caregivers." Studies have found that patients who receive detailed information before surgery often experience shorter hospital stays and fewer complications. Early results suggest that when patients better understand their care plan before surgery, they are less likely to need urgent care or be readmitted to the hospital. CareOrbit aids by providing easy online access to surgery-related information. Guidelines for better recovery emphasize that structured patient education is key to achieving improved recovery outcomes. ^{3 6 7 8 9}

Who Is on the Research Team?

Jason Rich, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had or will undergo major head and neck surgery, specifically free flap surgery or total laryngectomy. Participants must be able to speak English and have internet access to use the online education platform.

Inclusion Criteria

I have had or am having surgery to rebuild a part of my body using tissue from another part or I've had my voice box removed.

Have internet access

English speaking

Exclusion Criteria

I am under 18 years old.

No internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Education

Participants receive personalized online education to increase pre-operative preparedness and satisfaction

1-2 weeks

1 visit (in-person)

Post-operative Education and Monitoring

Participants and caregivers access online education and complete questionnaires at post-operative visits

3 months

2 visits (in-person), telephone follow-up

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CareOrbit

Trial Overview

The study is testing 'CareOrbit', an online patient education platform designed to help patients and caregivers prepare for before and after major head & neck surgeries. It aims to improve satisfaction with care and reduce unplanned medical visits post-surgery.

How Is the Trial Designed?

Group I: CareOrbit - Patients Experimental Treatment 1 Intervention

Patients will be assigned a username and password to access their CareOrbit account via the internet (caregivers will use the same account information). These patients may designate up to 3 additional individuals who will be participating in the patient's postoperative care to receive the link along with a unique username and password via email. All patients will additionally receive standard pre- and post-operative instructions and care. This will include verbal education by the surgeons at their pre-operative visits. Patient questionnaires will be distributed at the first and second post-operative visits (typically 1-2 weeks after discharge and 3 months after post-operative clinic visit). At 30 days following discharge, the patients' medical records will be reviewed by the study team to assess for the primary or secondary outcomes. Patients will be contacted by telephone to inquire about ED/UC visits outside of the BJC system.

Group II: CareOrbit - Caregivers Experimental Treatment 1 Intervention

Patients will be assigned a username and password to access their CareOrbit account via the internet (caregivers will use the same account information). These patients may designate up to 3 additional individuals who will be participating in the patient's postoperative care to receive the link along with a unique username and password via email. All patients will additionally receive standard pre- and post-operative instructions and care. This will include verbal education by the surgeons at their pre-operative visits. Patient questionnaires will be distributed at the first and second post-operative visits (typically 1-2 weeks after discharge and 3 months after post-operative clinic visit). At 30 days following discharge, the patients' medical records will be reviewed by the study team to assess for the primary or secondary outcomes. Patients will be contacted by telephone to inquire about ED/UC visits outside of the BJC system.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

The Foundation for Barnes-Jewish Hospital

Collaborator

Trials

43

Recruited

6,600+

Published Research Related to This Trial

A pilot study involving 168 elderly patients (over age 75) with head and neck cancer showed that perioperative consultations with geriatricians significantly improved preoperative medical optimization and postoperative care, with 87% of patients being discharged home after surgery.

The initiative demonstrated an overall survival rate of 80% at 24 months, indicating that geriatric support in surgical settings can enhance outcomes for elderly patients, and it has received positive feedback from patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new care paradigm in geriatric head and neck surgical oncology. Shuman, AG., Korc-Grodzicki, B., Shklar, V., et al.[2013]

The Multimode Comprehensive Tailored Information Package (MCTIP) significantly improved cancer knowledge and satisfaction among 96 Head and Neck cancer patients compared to standard care, with results showing higher levels of knowledge and satisfaction at all evaluation points (p<0.001).

This study highlights the importance of providing tailored information to meet patients' needs, suggesting that personalized information services can enhance the overall experience and understanding of cancer treatment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do multimedia based information services increase knowledge and satisfaction in head and neck cancer patients? D'Souza, V., Blouin, E., Zeitouni, A., et al.[2017]

The development of surgical pathways for head and neck cancer patients aims to improve patient and family education, helping them better understand complex treatment plans before surgery.

Implementing these pathways has the potential to enhance patient navigation through the surgical experience, although specific outcomes from the evaluation of these pathways were not detailed in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways for head and neck surgery: a patient-education tool. Clarke, LK.[2022]

This study is the first to rigorously evaluate a tailored DVD intervention aimed at reducing anxiety and improving empowerment in patients undergoing surgery for head and neck cancer, involving 156 participants.

The intervention will be assessed at three time points (preoperative, postoperative, and 3 months post-surgery) to determine its effectiveness compared to usual treatment, providing valuable insights into how personalized information can support patients and their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Protocol: Evaluation of a DVD intervention designed to meet the informaton needs of patients with head and neck cancer and their partner, carer and families. Parker, V., Bennett, L., Bellamy, D., et al.[2018]

A pilot study involving 35 patients undergoing major head and neck reconstructive surgery showed that those using an audiovisual education module reported higher satisfaction with their overall outcomes, with 87.5% finding the module useful.

While the intervention improved satisfaction, it did not significantly change patients' perceived involvement in their care, indicating a need for further enhancements based on patient feedback for future educational initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative patient-centered multimedia education in head and neck cancer patients: A pilot study. Amanian, A., Tran, KL., Wang, E., et al.[2022]

A total of 602 head and neck cancer survivors provided patient-reported outcomes through an Internet-based survivorship care plan program, highlighting the effectiveness of this approach in gathering valuable data.

The most common treatment-related toxicities reported were difficulty swallowing (61.5%) and changes in skin color/texture (49.7%), indicating that these issues, along with fatigue, are significant concerns that need to be addressed in survivorship care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. Peach, MS., Trifiletti, DM., Vachani, C., et al.[2022]

The AHNS Virtual Tumor Board, held from April 2020 to June 2022, featured 42 sessions with a strong focus on case-based learning, attracting an average of 217 views per session, indicating high engagement among participants.

Survey feedback from head and neck surgical oncology trainees revealed that 69% found the format excellent for teaching, and 76% believed practicing surgeons would benefit, highlighting its educational value as a remote learning tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Tumor Boards for Remote Learning in Head and Neck Surgical Oncology. Papazian, MR., Chow, M., Weed, D., et al.[2023]

The article outlines a quality assurance (QA) program developed for the EORTC 1420 phase III trial, which focuses on assessing swallowing function after transoral surgery versus radiation therapy in head and neck cancer patients.

The proposed QA program includes adaptable components tailored to specific surgical procedures and non-adaptable components that set minimal structural requirements for clinical units, aiming to enhance the reliability of surgical trials and potentially inform broader clinical practice guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical quality assurance in head and neck cancer trials: an EORTC Head and Neck Cancer Group position paper based on the EORTC 1420 'Best of' and 24954 'larynx preservation' study. Simon, C., Caballero, C., Gregoire, V., et al.[2019]

The LEARNS model, a structured health education and nursing supervision strategy, significantly reduced anxiety levels in patients with laryngeal tumors compared to traditional care, particularly noted one day before and seven days after surgery.

Patients using the LEARNS model showed improved treatment compliance, nursing satisfaction, self-care ability, and overall quality of life, highlighting its effectiveness in enhancing patient outcomes during the perioperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LEARNS Model as Perioperative Education Strategy for Patients with Laryngeal Tumors. Zhang, B., Sun, Q., Hu, S., et al.[2022]

Standardized preoperative phone calls did not significantly improve patient understanding or satisfaction in those undergoing endoscopic sinus surgery, as shown by similar scores between the intervention group and controls.

Postoperative call rates were not reduced by the educational intervention, suggesting that factors like patient demographics may play a more critical role in understanding and satisfaction than the preoperative education provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Utility of Preoperative Phone Calls for Endoscopic Sinus Surgery Procedures. Dang, S., McKeon, M., Menon, V., et al.[2021]

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