Mobile App Monitoring for Recurrent Head and Neck Cancer

(QUADSHOT Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Oklahoma

Disqualifiers: Recent radiotherapy, Radiation contraindications, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the uses of a mobile health-based assessment and symptom monitoring platform.

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's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Mobile App Monitoring for Recurrent Head and Neck Cancer?

Research shows that using mobile apps and electronic tools to monitor patients can help improve their quality of life by providing real-time feedback and support. For head and neck cancer patients, these tools have been used to track symptoms and quality of life, showing potential benefits in managing their care and reducing the burden of the disease. ^{1 2 3 4 5}

Is mobile app monitoring safe for humans?

The studies reviewed focus on the feasibility of using mobile apps and wearable devices to collect data from head and neck cancer patients, but they do not report any specific safety concerns related to the use of these technologies. ^{1 2 3 5 6}

How does the mobile app monitoring treatment for recurrent head and neck cancer differ from other treatments?

This treatment is unique because it uses a mobile app to monitor patients' health and quality of life in real-time, allowing for continuous and non-invasive data collection. Unlike traditional treatments that focus solely on medical interventions, this approach empowers patients by providing them with tools to track their own health and engage in their care actively. ^{2 3 5 7 8}

Research Team

Eligibility Criteria

This trial is for adults over 18 with a confirmed diagnosis of head and neck cancer that has come back or spread and can't be treated to cure it. At least six months must have passed since any previous radiotherapy. Participants need to be able to perform daily activities (with an ECOG status of 0-2) and agree to share their smoking history.

Inclusion Criteria

My head or neck cancer has returned or spread and cannot be cured with surgery, and it's been over 6 months since my last radiation therapy.

Must have evaluable lesion per RECIST v1.1

I am 18 years old or older.

Exclusion Criteria

I am currently pregnant.

I cannot have radiotherapy due to a genetic condition.

I have not had radiation in the cancer area within the last 6 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive radiation treatments via the QUAD shot regimen and use a smartphone app for daily symptom monitoring

11 weeks

Daily app-based assessments

Follow-up

Participants complete a final survey and a brief in-person or telephone interview to assess opinions about the app

1 week

1 visit (in-person or telephone)

Treatment Details

Interventions

• Ecologic Momentary Assessment (EMA) (Behavioural Intervention)

Trial Overview The study is testing the use of a mobile health platform for real-time assessment and symptom tracking in patients undergoing radiotherapy for recurrent head and neck cancer. It aims to understand how this technology impacts quality of life during treatment.

Participant Groups

Group I: Ecological Momentary Assessments (EMAs) Experimental Treatment 1 Intervention

Patients will receive one EMA (Ecologic Momentary Assessment) per day for approximately 75 days, through the provided smart phone application.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Dr. Scott Rollins

University of Oklahoma

Chief Executive Officer since 2016

PhD in Immunology from the University of Oklahoma

Dr. Ondria Gleason

University of Oklahoma

Chief Medical Officer

MD from the University of Oklahoma College of Medicine

Findings from Research

In a study of 65 patients undergoing head-and-neck radiotherapy, significant declines in quality of life (QOL) were observed, particularly in fatigue, social activity, and overall QOL, with 70.8% of patients reporting these issues during treatment.

The study highlighted that concurrent chemoradiotherapy (CCRT) led to more severe adverse events, including grade 3 complications in 35.4% of patients, significant weight loss averaging 5.5 kg, and a high need for supportive care interventions like intravenous hydration and feeding tube placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcomes and toxicities during radiotherapy for head-and-neck cancer. Niska, JR., Halyard, MY., Tan, AD., et al.[2023]

The study successfully collected patient-reported outcomes electronically from 318 head and neck cancer patients undergoing radiotherapy, demonstrating that this method is feasible for tracking symptoms during treatment.

Patients reported significant symptoms during radiotherapy, with the most severe being dysgeusia (taste changes), pain, and mucositis, particularly among those with oropharynx cancer, highlighting the need for targeted symptom management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures in patients undergoing radiotherapy for head and neck cancer. Hamilton, SN., Tran, E., Ho, C., et al.[2021]

The study involved 29 patients undergoing radiotherapy for head and neck cancer, but only 38% managed to provide step data for at least 80% of their treatment days, indicating challenges in continuous activity monitoring.

Higher daily step counts were associated with a significantly reduced risk of needing a feeding tube and hospitalization, suggesting that physical activity may play a protective role during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Activity Monitoring and Electronic Patient-Reported Outcomes Collection During Radiotherapy for Head and Neck Cancer: A Pilot Study. Ohri, N., Bar-Ad, V., Fernandez, C., et al.[2023]

Patients with head and neck cancer treated with intensity-modulated radiotherapy (IMRT) experienced a significant drop in quality of life (QOL) shortly after treatment, regardless of parotid gland sparing.

Higher radiation doses to the parotid gland (≥26 Gy) were associated with more severe and prolonged decreases in QOL, particularly affecting pain, chewing, and taste, highlighting the importance of minimizing radiation exposure to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttreatment quality-of-life assessment in patients with head and neck cancer treated with intensity-modulated radiation therapy. O'Neill, M., Heron, DE., Flickinger, JC., et al.[2022]

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 OncoWatch 1.0 feasibility study aims to assess whether patients with head and neck cancer can wear an Apple Watch continuously during radiotherapy, with a target of at least 12 hours per day.

This study will collect biometric data, such as heart rate and physical activity, to explore how these metrics change during treatment, potentially providing valuable insights for monitoring patient symptoms and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study. Holländer-Mieritz, C., Vogelius, IR., Kristensen, CA., et al.[2021]

Quality of life for patients with head and neck cancer significantly declines during radiotherapy but shows gradual improvement in the months following treatment, as observed in a study of 166 participants over a year.

The study found that HPV-positive patients experienced different factors affecting their quality of life compared to HPV-negative patients, highlighting the importance of tailoring treatments based on individual patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life changes over time and predictors in a large head and neck patients' cohort: secondary analysis from an Italian multi-center longitudinal, prospective, observational study-a study of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) head and neck working group. Viganò, A., De Felice, F., Iacovelli, NA., et al.[2023]

A systematic review of 42 studies on ecological momentary assessment (EMA) in cancer research revealed that most studies utilized electronic devices for data collection, highlighting the potential of EMA to enhance real-time data capture and reduce retrospective bias in understanding patient experiences.

Despite the promise of EMA to improve cancer care research, significant variability in study methods and self-report measures was found, indicating a need for standardized EMA questionnaires developed in collaboration with cancer survivors to ensure relevance and acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Landscape of Ecological Momentary Assessment (Real-Time Data) Methodology in Cancer Research: A Systematic Review. Paterson, C., Armitage, L., Turner, M.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcomes and toxicities during radiotherapy for head-and-neck cancer. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures in patients undergoing radiotherapy for head and neck cancer. [2021]

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

Remote Activity Monitoring and Electronic Patient-Reported Outcomes Collection During Radiotherapy for Head and Neck Cancer: A Pilot Study. [2023]

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

Posttreatment quality-of-life assessment in patients with head and neck cancer treated with intensity-modulated radiation therapy. [2022]

5. 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]

6. Canada pubmed.ncbi.nlm.nih.gov

Using Biometric Sensor Data to Monitor Cancer Patients During Radiotherapy: Protocol for the OncoWatch Feasibility Study. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Quality of life changes over time and predictors in a large head and neck patients' cohort: secondary analysis from an Italian multi-center longitudinal, prospective, observational study-a study of the Italian Association of Radiotherapy and Clinical Oncology (AIRO) head and neck working group. [2023]

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

Current Landscape of Ecological Momentary Assessment (Real-Time Data) Methodology in Cancer Research: A Systematic Review. [2023]