Internet-Based Intervention for Head and Neck Cancer

Recruiting at 1 trial location

Overseen By Eileen H Shinn

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-throat cancer, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program called Project Prepare, designed to help head and neck cancer patients adhere to important exercises and coping strategies. These patients often experience long-term swallowing problems after radiation therapy. The program provides videos, tips, recipes, and stress relief strategies to aid recovery and improve quality of life. It suits those receiving radiation to cure throat cancer who can read and speak English or Spanish. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in cancer recovery strategies.

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 focuses on a web-based program to help with exercises and coping strategies for head and neck cancer patients.

What prior data suggests that this web-based program is safe for head and neck cancer patients?

Research has shown that web-based programs like Project Prepare are designed to assist patients with head and neck cancer. These programs help patients adhere to exercises and coping methods, which are crucial after radiation therapy. Patients generally respond well to such programs. A previous study found that a similar web-based program received positive feedback from patients with head and neck cancer, suggesting these programs are safe and easy to use.

The current trial is in Phase 2, gathering information on how well patients handle the program. Phase 2 trials often examine safety more closely. Since the program is online and focuses on supportive care (helping patients manage symptoms), it is likely low-risk. No reports of harmful side effects have emerged from using these kinds of programs. Overall, the safety evidence so far indicates that patients tolerate the program well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Project Prepare because it offers a unique, internet-based approach to supporting head and neck cancer patients. Unlike traditional treatments that often require in-person visits, this intervention provides patients with easy online access to helpful resources like exercise videos, stress relief strategies, and dietary tips, all from the comfort of their homes. This is particularly beneficial for underserved populations who might lack access to specialized care. By integrating diverse resources into a single platform, Project Prepare aims to enhance patient well-being during treatment in a more convenient and personalized way.

What evidence suggests that the Project Prepare web-based program is effective for head and neck cancer patients?

Studies have shown that online programs can help patients with head and neck cancer adhere to important exercises and coping strategies. Research indicates that digital tools can simplify following care plans, enhancing recovery. For example, online programs have been found to assist patients in managing side effects like swallowing problems, common after radiation therapy. In this trial, participants will use Project Prepare, a web-based program designed to provide easy access to these tools, potentially improving long-term recovery for those lacking access to specialized care. Early findings suggest that digital health tools like Project Prepare can significantly improve patient outcomes by supporting adherence to treatment exercises. ^{1 2 3 4 5}

Who Is on the Research Team?

Eileen H Shinn

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with head and neck cancer, specifically those undergoing radiation therapy aimed at curing throat cancer. Participants must be able to read and speak English or Spanish well enough to use the web-based program and respond to questionnaires.

Inclusion Criteria

You are currently undergoing radiation treatment to cure throat cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Project Prepare website to view videos of swallowing and trismus exercises, tips, and other resources over 10 weeks

10 weeks

Follow-up

Participants are monitored for changes in self-reported swallowing function and website usage data

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Project Prepare

Trial Overview The study is testing 'Project Prepare,' a web-based program designed to help patients stick to swallowing exercises and learn coping strategies. The goal is to see if this tool can improve adherence and reduce long-term side effects from radiation therapy.

How Is the Trial Designed?

Group I: Supportive Care (Project Prepare website) Experimental Treatment 3 Interventions

Patients use the password-protected Project Prepare website on a computer, tablet, or phone over 10 weeks to view: videos of the swallowing and trismus exercises, tips and stories from former patients, what to expect each week of treatment, recipes and cooking demonstrations, how to take care of their teeth during treatment, strategies for stress relief, and strategies for dry mouth and nausea. This website is designed to reach underserved populations who do not have ready access to specialized preventive care.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The BD4QoL study aims to improve the quality of life (QoL) for head and neck cancer survivors by using a mobile app and monitoring platform to track health-related data over 24 months, involving 420 participants.

This clinical trial will compare the effectiveness of the BD4QoL platform against standard follow-up care, with the goal of reducing clinically relevant QoL deterioration in patients who have completed their cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter randomized trial for quality of life evaluation by non-invasive intelligent tools during post-curative treatment follow-up for head and neck cancer: Clinical study protocol. Cavalieri, S., Vener, C., LeBlanc, M., et al.[2023]

A new data collection instrument for patients with head and neck cancer was developed and validated, consisting of 56 questions after rigorous evaluation by eight nursing judges.

The instrument demonstrated strong content validity with a global Content Validity Index (CVI) of 0.87, indicating it is a reliable tool for gathering relevant patient data in a specialty clinic setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head and neck cancer: validation of a data collection instrument. Rodrigues, AB., Cunha, GHD., Aquino, CBQ., et al.[2019]

This study aims to determine if a reminder app can reduce the rates of severe radiation dermatitis and oral mucositis in patients undergoing radiotherapy for head-and-neck cancer, with 168 patients expected to be randomized into two groups: one receiving standard care and the other receiving standard care plus the app.

The primary goal is to achieve a clinically relevant reduction of at least 20% in grade ≥2 radiation dermatitis, which could significantly improve patient outcomes and quality of life during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis. Rades, D., Narvaez, CA., Doemer, C., et al.[2021]

In a comparison of two large studies, the Scottish Audit of Head and Neck Cancer (SAHNC) and the South and West Audit of Head and Neck Cancer (SWAHN), it was found that patients in Scotland were generally younger and had a higher prevalence of advanced laryngeal cancer compared to those in the South and West of the UK.

Despite differences in demographics and disease stage, the five-year survival rates for head and neck cancer patients were nearly identical between the two regions, suggesting that treatment processes may be similarly effective across diverse healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Processes and outcomes of head and neck cancer patients from geographically disparate regions of the UK. A comparison of Scottish and English cohorts. MacKenzie, K., Savage, SA., Birchall, MA.[2019]

A scoping review of 13 empirical studies and 32 websites revealed that web-based interventions for head and neck cancer (HNC) primarily focus on providing information, support during treatment, and management strategies for survivorship, but lack depth in aiding shared decision-making.

There is a significant need for more theory-based, co-designed web interventions that incorporate patient narratives, which could enhance decision-making and preparedness for treatment among HNC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Availability and use of web-based interventions for patients with head and neck cancer: a scoping review. Kelly, R., Gordon, P., Thompson, R., et al.[2023]

The Northern California Head and Neck Cancer Network established a comprehensive community effort for the detection and management of head and neck cancers, involving 72 institutions and targeting a population of nearly 9 million, which led to improved standards of care and referral patterns for 1,790 patients.

Despite the success in improving care, the screening programs implemented were found to be not cost-effective, highlighting the need for ongoing evaluation and adjustment of cancer control strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of network organization on head and neck cancer control. Silverman, S., Naeve, PP.[2007]

Patients with head and neck cancer (HNC) value patient-reported outcome measures (PROMs) that include a call to action for those with worse-than-average scores, indicating a desire for proactive support based on their reported outcomes.

Healthcare professionals (HCPs) prioritize discussing PROM scores during clinical visits, suggesting that integrating these discussions into patient care could enhance the clinical value of PROMs and improve patient involvement in their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' and Healthcare Professionals' Perspectives on Better Use of Patient-Reported Outcome Measures in Head and Neck Cancer. de Jel, DVC., Young-Afat, DA., Ooms-Renckens, MM., et al.[2023]

The web-based program 'My Journey Ahead' was developed to help patients with head and neck cancer manage treatment side effects and was well-received, with 44 out of 55 participants finding it informative and easy to use.

Patients reported high satisfaction levels, particularly older individuals and those with greater self-efficacy in coping, indicating that the program effectively addresses the informational needs of cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Supportive Care Program for Patients With Head and Neck Cancer. Fang, CY., Galloway, TJ., Egleston, BL., et al.[2022]

A web-based application developed for pharyngeal and laryngeal cancer patients significantly promoted adherence to preventive swallowing exercises, with increased website visits correlating with better exercise compliance.

Despite its effectiveness, the platform's usability and navigability need improvement to better serve older patients in community settings, as indicated by the low return visit rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive website for head and neck cancer patients: Adherence and coping program to prevent dysphagia after radiation. Shinn, EH., Jensen, K., McLaughlin, J., et al.[2023]

The study developed a computerized clinical outcome assessment tool (COAT-HNC) for head and neck cancer patients, which was found to be easy to use and generated structured summary reports that facilitated patient-physician communication during clinical visits.

In a cohort of 385 patients, the COAT-HNC demonstrated good internal consistency and feasibility, suggesting it could effectively support treatment evaluation and planning, although further research is needed to confirm its clinical utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a computerized clinical outcome assessment tool for head and neck cancer patients. Lin, CR., Fan, KH., Lin, CY., et al.[2022]

A randomized controlled trial developed a group intervention program for head and neck cancer patients, focusing on improving work ability, quality of life, and psychological well-being, with positive feedback from participants in a pilot group.

The involvement of a peer (a former head and neck cancer patient) in the intervention was highlighted as crucial for patient satisfaction and engagement, suggesting that peer support may enhance the effectiveness of psycho-oncological counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A group intervention to promote work ability in patients with head and neck cancer]. Broemer, L., Esser, P., Koranyi, S., et al.[2022]

The implementation of the electronic Patient-Reported Outcome Measure (PROM) 'OncoFunction' in head and neck cancer patients showed high feasibility, with 846 patients completing the PROM during 2,833 out of 3,610 visits (78.5%).

The latest version of 'OncoFunction' significantly reduced errors and time required for use, enhancing the efficiency of data collection and improving patient follow-up care by providing a comprehensive view of their health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. Zebralla, V., Müller, J., Wald, T., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8711568/

The PREPARE for Your Care Program Increases Advance ... PREPARE plus an easy-to-read AD increased ACP documentation and engagement among diverse, older adults with cancer more than an AD alone.

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.602202/full

Development of a Web-Based Supportive Care Program ... In Phase 1, five patients with head and neck squamous cell carcinoma (HNSCC) reviewed the web-based program and provided initial feedback, which ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8794623/

Availability and use of web-based interventions for patients ... Purpose. To identify and review the nature, scope and use of web-based interventions for patients with head and neck cancer (HNC).

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388925002248

Effectiveness and determinants of a Digital Health ... To evaluate the impact of a digital health application using the Health Belief Model and computer vision on head and neck cancer rehabilitation, ...

5. mdpi.com mdpi.com/2072-6694/17/14/2345

Enhancing Patient Outcomes in Head and Neck Cancer ... This study explored the use of an Artificial Intelligence (AI)-powered electronic patient-reported outcomes (ePRO) system combining large language models ...