NCT02756767

Brief Summary

The goals of this study are to assess the feasibility of weekly administration of site specific patient reported assessments using an electronic platform and to explore the correlation between patient reported outcomes as well as known dosimetric prognostic factors in patients with lung, breast, head and neck, or pelvic malignancies

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

April 28, 2016

Last Update Submit

June 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Surveys completed

    five years

Study Arms (1)

Completed subjects

Subjects will complete patient-reported outcomes assessments during and after radiation therapy.

Other: Survey

Interventions

SurveyOTHER
Completed subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.

You may qualify if:

  • Patients with breast cancer, lung cancer, head and neck cancer, or gynecologic cancer receiving definitive external beam radiotherapy.
  • Must be ≥ 18 years of age
  • Able to read, write, and speak English in order to complete patient reported outcomes.
  • Patients will be approached about the study at the time of consultation or at the time of simulation by their treating physicians or by a research coordinator. All patients must sign a study-specific informed consent to participate. All patients, including those who do not choose to consent to the study, will be provided with a short survey to assess health literacy using the eHealth Literacy Scale (eHEALS).
  • For those not consenting to the study, the survey will be de-identified and will also ask for basic demographic information including age grouping, race, education level, and type of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Lilie Lin, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

April 29, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

June 7, 2021

Record last verified: 2021-06

Locations