300 Participants Needed

Internet-Based Intervention for Head and Neck Cancer

Recruiting at 1 trial location
EH
Overseen ByEileen H Shinn
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

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.12345

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.12678

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.29101112

Who Is on the Research Team?

EH

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?
1Treatment groups
Experimental Treatment
Group I: Supportive Care (Project Prepare website)Experimental Treatment3 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.

Find a Clinic Near You

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

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

Citations

Patients' and Healthcare Professionals' Perspectives on Better Use of Patient-Reported Outcome Measures in Head and Neck Cancer. [2023]
Development and evaluation of a computerized clinical outcome assessment tool for head and neck cancer patients. [2022]
[A group intervention to promote work ability in patients with head and neck cancer]. [2022]
Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. [2020]
Availability and use of web-based interventions for patients with head and neck cancer: a scoping review. [2023]
Head and neck cancer: validation of a data collection instrument. [2019]
Processes and outcomes of head and neck cancer patients from geographically disparate regions of the UK. A comparison of Scottish and English cohorts. [2019]
Development of a Web-Based Supportive Care Program for Patients With Head and Neck Cancer. [2022]
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]
Interactive website for head and neck cancer patients: Adherence and coping program to prevent dysphagia after radiation. [2023]
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 Statespubmed.ncbi.nlm.nih.gov
Impact of network organization on head and neck cancer control. [2007]
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