Internet-Based Intervention for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Eileen H Shinn

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Non-throat cancer, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well a web-based program called Project Prepare works in helping patients with head and neck cancer adhere to swallowing and trismus exercises and coping strategies. Head and neck cancer patients who receive radiation therapy are at risk for permanent swallowing disorders and other side effects. Because of these potential problems, swallowing exercises and coping strategies are important parts of recovery. A web-based program designed to increase adherence to preventive exercises may help patients with head and neck cancer ameliorate the long-term effects of radiation therapy.

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 data supports the effectiveness of the treatment Project Prepare Web-Based Program for head and neck cancer?

The use of web-based interventions and electronic patient-reported outcome measures (PROMs) has shown promise in improving patient care for head and neck cancer by facilitating better communication and treatment planning between patients and healthcare providers. These tools help in assessing patients' quality of life and functional outcomes, which are crucial for comprehensive aftercare. ^{1 2 3 4 5}

Is the Internet-Based Intervention for Head and Neck Cancer safe for humans?

The web-based program 'My Journey Ahead' for head and neck cancer patients was well-received, with participants reporting high satisfaction and finding it easy to use, suggesting it is safe for human use. ^{5 6 7 8 9}

How does the internet-based intervention for head and neck cancer differ from other treatments?

This internet-based intervention is unique because it uses a web-based application to help patients adhere to preventive swallowing exercises and cope with radiation side effects, which is not typically addressed by standard treatments. It provides a convenient and accessible way for patients to manage their condition and improve their quality of life through digital tools. ^{5 8 10 11 12}

Research Team

Eileen H Shinn

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Can read and speak English or Spanish well enough to answer our questionnaires and understand our website content.

Trial Timeline

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

Treatment Details

Interventions

• Project Prepare (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

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]

References

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

Development and evaluation of a computerized clinical outcome assessment tool for head and neck cancer patients. [2022]

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

Patients' and Healthcare Professionals' Perspectives on Better Use of Patient-Reported Outcome Measures in Head and Neck Cancer. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

[A group intervention to promote work ability in patients with head and neck cancer]. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. [2020]

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

Availability and use of web-based interventions for patients with head and neck cancer: a scoping review. [2023]

6. England 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. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Supportive Care Program for Patients With Head and Neck Cancer. [2022]

8. Brazil pubmed.ncbi.nlm.nih.gov

Head and neck cancer: validation of a data collection instrument. [2019]

9. England 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. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Interactive website for head and neck cancer patients: Adherence and coping program to prevent dysphagia after radiation. [2023]

11. Switzerland 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. [2023]

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

Impact of network organization on head and neck cancer control. [2007]