NCT00400699

Brief Summary

RATIONALE: An outreach program may help minority or low-income cancer patients overcome problems that keep them from receiving quality care. PURPOSE: This clinical trial is studying how well a radiation therapy outreach program works in minority or low-income patients with newly diagnosed cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
3,150

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

4 active sites

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

October 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

5.1 years

First QC Date

November 16, 2006

Last Update Submit

January 30, 2014

Conditions

Psychosocial Effects of Cancer and Its TreatmentUnspecified Adult Solid Tumor, Protocol Specific

Keywords

psychosocial effects of cancer and its treatmentunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (9)

  • Clinical stage at time of presentation (indicator of early access to system)

    Observation

  • Date and nature of post-diagnosis surgery or biopsy

    Observation

  • Proportion of patients compliant with treatment plan

    Observation

  • Total radiation dosage per patient (curative and palliative endpoints)

    Observation

  • Supportive services provided to patients

    Observation

  • Rate of treatment completion

    Observation

  • Accrual for clinical research protocols

    Observation

  • Retention in clinical research protocols

    Observation

  • Barriers to treatment (perceived and real)

    Observation

Study Arms (1)

REview

OTHER
Other: counseling interventionOther: study of socioeconomic and demographic variablesProcedure: psychosocial assessment and care

Interventions

counseling interventionOTHER
REview
study of socioeconomic and demographic variablesOTHER
REview
psychosocial assessment and carePROCEDURE
REview

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Newly diagnosed cancer * Receiving radiation therapy and/or chemotherapy * Minority and/or economically disadvantaged population PATIENT CHARACTERISTICS: * Within any of the following service areas of 5 different hospitals in western Pennsylvania: * New Castle * Pittsburgh Metro * Somerset * Mckeesport * Johnstown * Any race, ethnicity, gender, or HIV status allowed * HIV serostatus is not evaluated specifically for study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, 15132, United States

Location

UPMC Cancer Center - New Castle

New Castle, Pennsylvania, 16105, United States

Location

Mercy Cancer Institute at Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Somerset Oncology Center

Somerset, Pennsylvania, 15501, United States

Location

MeSH Terms

Interventions

CounselingPsychiatric Rehabilitation

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitationTherapeutics

Study Officials

  • Dwight E. Heron, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FACRO, FACR

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

October 1, 2004

Primary Completion

November 1, 2009

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

US(4)