Mobile App Monitoring for Recurrent Head and Neck Cancer

(QUADSHOT Trial)

Overseen By SCC IIT Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Recent radiotherapy, Radiation contraindications, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to monitor symptoms in patients with certain types of recurrent or metastatic head and neck or gynecologic cancers. The goal is to determine if the app improves symptom tracking and management. Participants will use the app daily for about 75 days. Individuals whose head and neck or gynecologic cancer has returned or spread, and who cannot undergo more intensive treatment, might be suitable candidates. The app employs a method called Ecologic Momentary Assessment (EMA), also known as Experience Sampling Method (ESM) or Ambulatory Assessment, to collect real-time symptom data. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance symptom management for future patients.

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 prior data suggests that this mobile app monitoring is safe for recurrent head and neck cancer?

Research has shown that Ecologic Momentary Assessment (EMA) is generally easy and comfortable for people to use. EMA employs a smartphone app to track real-time thoughts and feelings. In studies with cancer patients, including those with head and neck cancer, most participants expressed high satisfaction with the app. For instance, one study found that about 70% of participants were happy with their experience.

Importantly, no serious side effects or health problems have been reported from using EMA. It involves answering questions on a smartphone about symptoms or feelings, making it non-invasive and safe. This makes EMA a promising tool for monitoring health without causing stress or discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Ecologic Momentary Assessment (EMA) for recurrent head and neck cancer because it offers a real-time, personalized approach to monitoring patients' conditions. Unlike traditional methods that rely on periodic clinic visits and retrospective evaluations, EMA captures patients' symptoms and experiences daily through a smartphone app. This innovative method provides a more comprehensive and immediate understanding of a patient's health, potentially leading to more timely and tailored interventions. By leveraging technology, EMA aims to enhance patient engagement and improve the overall management of the condition.

What evidence suggests that this mobile app monitoring is effective for recurrent head and neck cancer?

Studies have shown that Ecologic Momentary Assessment (EMA) can be helpful in cancer research. EMA uses a smartphone app to record a person's thoughts, feelings, and symptoms in real-time. This method captures information that might be missed during regular doctor visits. Research indicates that patients find EMA easy to use and effective for tracking symptoms. One study found that 70.4% of cancer patients, including those with head and neck cancer, were satisfied with using an EMA app. In this trial, participants will receive one EMA per day for approximately 75 days through the provided smartphone application. This suggests that EMA could be a promising way to manage and understand symptoms in head and neck cancer. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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

Written informed consent and any locally-required authorization obtained from the patients prior to performing any protocol-related procedures, including screening evaluations

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Ecologic Momentary Assessment (EMA)

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9285429/

Ecological momentary assessments among patients with ...

Ecological momentary assessment (EMA) is an emerging method to assess an individual's current thoughts, affect, behaviour, physical states and contextual ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0749208123001638

Current Landscape of Ecological Momentary Assessment ...

This is the first comprehensive systematic review to describe the use and methods of EMA in cancer research.

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frontiersin.org

frontiersin.org/journals/oncology/articles/10.3389/fonc.2022.880430/full

Smartphone-Based Ecological Momentary Assessment for ...

We assessed 69 patients (53 lung cancer, 8 gastrointestinal stromal tumors, 5 sarcomas, and 3 head and neck cancer). Concerning app satisfaction, 70.4% (20 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7168577/

An Ecological Momentary Assessment Study Investigating ...

To address the above-mentioned research gaps, the current study used ecological momentary assessment (EMA) data to determine the extent to which daily self- ...

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researchgate.net

researchgate.net/publication/337234703_An_Ecological_Momentary_Assessment_Study_Investigating_Self-efficacy_and_Outcome_Expectancy_as_Mediators_of_Affective_and_Physiological_Responses_and_Exercise_Among_Endometrial_Cancer_Survivors

An Ecological Momentary Assessment Study Investigating ...

Exercise Self-Efficacy in Head and Neck Cancer Survivors: A ... Designing daily-life research combining experience sampling method with parallel data.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31090160/

Ecological momentary assessments among patients with ...

Ecological momentary assessment (EMA) is an emerging method to assess an individual's current thoughts, affect, behaviour, physical states and contextual ...

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mdpi.com

mdpi.com/1660-4601/18/11/5991

Characterizing Breakthrough Cancer Pain Using ...

Background: mobile applications (apps) facilitate cancer pain ecological momentary assessment (EMA) and provide more reliable data than retrospective monitoring

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researchgate.net

researchgate.net/publication/361992751_Smartphone-Based_Ecological_Momentary_Assessment_for_the_Measurement_of_the_Performance_Status_and_Health-Related_Quality_of_Life_in_Cancer_Patients_Under_Systemic_Anticancer_Therapies_Development_and

Smartphone-Based Ecological Momentary Assessment for ...

We assessed 69 patients (53 lung cancer, 8 gastrointestinal stromal tumors, 5 sarcomas, and 3 head and neck cancer). Concerning app satisfaction ...