Education Booklet & Standardized Discharge Training for Head and Neck Cancers

Overseen By Rod Rezaee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: No caregiver, Illiterate, Previous tracheostomy, others

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

Compensation: Varies

Number of Visits: 7

75 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to identify and establish a safe and effective tracheostomy teaching protocol for caregivers. Results of this study will help in the development of a discharge protocol that allows for caregiver confidence and activation in tracheostomy care for patients.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Education booklet & standardized discharge training for head and neck cancers?

Research shows that providing educational interventions during the discharge phase can improve patients' satisfaction with the information they receive. Additionally, structured care pathways, which include educational components, have been effective in improving outcomes for head and neck cancer patients. ^{1 2 3 4 5}

Is the educational booklet and discharge training safe for head and neck cancer patients?

The educational intervention for head and neck cancer patients during discharge is designed to provide important information and improve patient satisfaction, but there is no specific safety data mentioned for this intervention. ^{1 4 6 7 8}

How does the Education Booklet & Standardized Discharge Training treatment differ from other treatments for head and neck cancers?

This treatment is unique because it focuses on providing comprehensive educational resources and discharge training to improve patients' knowledge and satisfaction, rather than directly treating the cancer itself. It addresses the informational needs of patients, helping them better understand their condition and manage their care after leaving the hospital. ^{1 4 9 10 11}

Research Team

Rod Rezaee, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for adult patients with head and neck cancers who have had a tracheostomy and will keep it for at least 10 days after leaving the hospital. They need a caregiver aged 18+ without prior tracheostomy experience, who can read and is not going to a nursing facility.

Inclusion Criteria

I am over 18 and care for someone eligible for this trial.

My tracheostomy has been in place for at least 10 days after I left the hospital.

I am the main person helping with daily needs.

Exclusion Criteria

Patients who do not have a caregiver

My tracheostomy tube has been removed before leaving the hospital.

Caregivers who are illiterate.

Timeline

Pre-implementation

Assessment of healthcare utilization costs and nursing perspective on current caregiver tracheostomy knowledge

4 weeks

1 visit (in-person)

Protocol

Assessment of the necessity, acceptability, feasibility, fidelity, safety, and effectiveness of a standardized pathway and caregiver activation

4 weeks

3 visits (in-person), 1 visit (virtual)

Post-implementation

Assessment of post-implementation tracheostomy-related healthcare utilization costs and nursing perspective on caregiver tracheostomy knowledge

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after implementation

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Education booklet & standardized discharge training

Trial Overview The study tests an educational booklet & standardized discharge training protocol aimed at improving caregivers' ability to confidently manage tracheostomy care post-discharge from the hospital.

Participant Groups

Group I: Tracheostomy discharge protocol Experimental Treatment 1 Intervention

All head and neck cancer patients regardless of participation in the study will receive the standard of care: A copy of a tracheostomy education booklet and standardized discharge training for patients and their caregivers by nursing staff during their inpatient stay. Research personnel will provide protocol training to the inpatient nurses who are to provide training to caregivers. Pre-implementation phase: Eligible "patient" participants identified \& healthcare utilization recorded. "Nursing staff" participants complete nursing survey to capture volume of tracheostomy-related questions received. Protocol-phase: "Caregiver" participants will complete a survey prior to patient tracheostomy, on day of patient discharge, and one week following discharge Post-implementation phase: "Nursing staff" participants will complete an additional survey similar to the one in the pre-implementation phase. EMR will be reviewed for implementation fidelity.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

Implementing a comprehensive clinical care pathway for 55 patients undergoing major head and neck surgery significantly reduced pulmonary complications by 32.5% and shortened hospital stays by an average of 7.4 days.

The care pathway was found to be safe, with no increase in flap reoperation rates, suggesting it is an effective strategy for improving postoperative outcomes in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of pulmonary complications and hospital length of stay with a clinical care pathway after head and neck reconstruction. Yeung, JK., Dautremont, JF., Harrop, AR., et al.[2022]

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]

This ongoing randomized trial involves 150 head-and-neck cancer patients and aims to improve adherence to prophylactic swallowing exercises (PSE) by comparing three different delivery methods: home exercises, home exercises with app counseling, and face-to-face therapy with a speech pathologist.

The study will evaluate the impact of these adherence-improving measures on patients' swallowing function and quality of life, highlighting the importance of maximizing adherence to enhance the effectiveness of PSE after (chemo)radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial). Baudelet, M., Van den Steen, L., Duprez, F., et al.[2020]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

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]

References

1. Scotland pubmed.ncbi.nlm.nih.gov

Educational intervention for patients with head and neck cancer in the discharge phase. [2015]

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

Evaluation of an intervention to enhance the delivery of smoking cessation services to patients with cancer. [2022]

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

Reduction of pulmonary complications and hospital length of stay with a clinical care pathway after head and neck reconstruction. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Do multimedia based information services increase knowledge and satisfaction in head and neck cancer patients? [2017]

5. England pubmed.ncbi.nlm.nih.gov

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial). [2020]

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

Improving patient safety in the inpatient setting through risk assessment and mitigation. [2016]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes in head and neck cancer: prospective multi-institutional patient-reported toxicity. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Advances in understanding of toxicities of treatment for head and neck cancer. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Information Needs of Patients Diagnosed with Head and Neck Cancer Undergoing Radiation Therapy: a Survey of Patient Satisfaction. [2021]

10. Brazil pubmed.ncbi.nlm.nih.gov

Validation of an educative manual for patients with head and neck cancer submitted to radiation therapy. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Examining clinicians' perceptions of head and neck cancer (HNC) information. [2019]