NCT00824252

Brief Summary

The goal of this research study is to look at social and relationship factors that may affect the quality of life of patients with head and neck cancer and their spouses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

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

December 8, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
13.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2022

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

13.2 years

First QC Date

January 15, 2009

Last Update Submit

March 4, 2022

Conditions

Keywords

Head And Neck CancerHNCRadiation TherapySpousal SupportEmotional DisclosureObservationalSocial ConstraintsQuestionnairesVideotaped InterviewQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Social + Relationship Factors Affecting QOL of HNC Patients & Spouses

    12 Months

Study Arms (1)

Spousal Support

Questionnaire for Head and Neck Cancer Patients + Spouses

Behavioral: Questionnaires & Study Visit

Interventions

Individual Questionnaires (1 hour) and videotaped discussion during Study Visit (1 1/4 hours)

Also known as: Survey
Spousal Support

Eligibility Criteria

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

Head and neck cancer patients who will be starting radiation therapy and their spouses.

You may qualify if:

  • Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer
  • Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less
  • Part 2. Patient has a spouse or significant other with whom he/she resides
  • Part 2. Patient is able to vocalize well enough to complete the spousal interaction task
  • Parts 1 and 2. Patient and spouse are able to read and speak English
  • Parts 1 and 2. Patient and spouse are able to provide informed consent
  • Parts 1 and 2. Patient and spouse are at least 18 years of age
  • Part 1. Individual is a patient who was diagnosed with head and neck cancer or the spouse or partner of an patient who was diagnosed with head and neck cancer and resides with the patient.

You may not qualify if:

  • \) None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Kathrin Milbury, PHD, MA

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

December 8, 2008

Primary Completion

February 23, 2022

Study Completion

February 23, 2022

Last Updated

March 8, 2022

Record last verified: 2022-03

Locations