Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer

NCT05850663 | Withdrawn

• 1 other identifier: Quadshot mHealth
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Head and Neck Cancer; Cervical Cancer; Endometrial Cancer; Gynecologic Cancer

Keywords

Radiation Therapy; Mobile Health; QUADSHOT; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction via qualitative interview and app based EMAs

  Proportion of patients satisfied with the mHealth app. Patient satisfaction will be collected during the follow-up qualitative interview, and data will be analyzed using qualitative methods. The intervention will be deemed feasible if at least 75% of patients report that the app is easy to use and useful. Specifically, we will describe how often the app is used to measure symptoms, treatment effects, medication adherence, and pain, as well as HR-QOL and barriers to care.

  75 days

• Patient perceptions of mHealth platform

  Proportion of patients who deem the mHealth app easy to use and useful. To gauge patient perception of mHealth platform with feedback from qualitative interview and app based EMAs. The final survey asks questions on the patients' thoughts, feelings, and opinions about the intervention they received over the course of the study.

  75 days

Secondary Outcomes (4)

• Feasibility of intervention

  75 days

• Patient-reported barriers to care

  75 days

• Changes in weekly FACT-HN, FACT-Cx, or FACT-En scores over time

  75 days

• Completion rates of daily questionnaires

  75 days

Study Arms (1)

Ecological Momentary Assessments (EMAs)

OTHER

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

Other: Ecologic Momentary Assessment (EMA)

Interventions

Ecologic Momentary Assessment (EMA) OTHER

EMA enables measurement of phenomena in real-time, natural settings. EMA data will be used to identify moments of high distress, assess cancer treatment side effects, and assess barriers to care. The EMA methodology used in this study will ask about current emotional, physical, behavioral, and social states. The EMAs will consist of time-based sampling (i.e. a daily dairy), which will be prompted and initiated by the phone.

Ecological Momentary Assessments (EMAs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and older
• Written informed consent and any locally-required authorization obtained from the patients prior to performing any protocol-related procedures, including screening evaluations
• Pathologically (histologically or cytologically) proven diagnosis of cancer of the head and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary) or Gynecologic cancers (cervical and endometrial)
• Locally recurrent or metastatic HNC or Gyn cancer not deemed amenable to curative-intent salvage therapy, in whom at least six months have passed since their prior RT, if received
• Must have evaluable lesion per RECIST v1.1
• Patients agree to provide their smoking history prior to registration
• ECOG performance status of 0-2

You may not qualify if:

• Prior radiotherapy to the region of the study cancer within less than 6 months
• Patients who have received prior radiation therapy and who, in the opinion of the treating radiation oncologist, cannot be reirradiated safely without excess risk of severe toxicity given prior radiation dose to critical structures.
• Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia-Telangiectasia, Nijmegen Breakage Syndrome)
• Female patients who are pregnant

Sponsors & Collaborators

• University of Oklahoma: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: June 1, 2025
• Primary Completion: June 4, 2025
• Study Completion: June 4, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share