Recruiting

Quality of Life

Sponsor:

University of Oklahoma

Code:

NCT05850663

Conditions

Head and Neck Cancer

Gynecologic Cancer

Cervical Cancer

Endometrial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ecologic Momentary Assessment (EMA)

Study Details

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

Gynecologic Cancer

Cervical Cancer

Endometrial Cancer

Study ID

NCT05850663

Start date

May 20, 2025

Status verified date

Apr, 2025

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Ecological Momentary Assessments (EMAs)

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

Interventions

Ecologic Momentary Assessment (EMA)

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.

Primary outcome measure

  • Patient satisfaction via qualitative interview and app based EMAs [ Time Frame: 75 days ]
  • Patient perceptions of mHealth platform [ Time Frame: 75 days ]

Central Contacts and Locations

Central contacts

SCC IIT Office

1-405-271-8777SCC-IIT-Office@ouhsc.edu

Locations

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Lead Nurse

405-271-8777SCC-IIT-Office@ouhsc.edu

Principal Investigator:

Christina Henson, MD

More Information

Sponsor

University of Oklahoma

Last update posted

Apr 30, 2025

Last verified

Apr, 2025

Keywords

  • Radiation Therapy
  • Mobile Health
  • QUADSHOT
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2025-04-30.