Psychosocial Effects of Cancer and Its TreatmentNCT00400699
Radiation Therapy Outreach Program for Minority or Low-Income Patients With Newly Diagnosed Cancer
A study testing counseling intervention, study of socioeconomic and demographic variables and psychosocial assessment and care in people with Psychosocial Effects of Cancer and Its Treatment and Unspecified Adult Solid Tumor, Protocol Specific, run by University of Pittsburgh at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- counseling intervention, study of socioeconomic and demographic variables and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,150 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2004to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132
UPMC Cancer Center - New Castle
New Castle, Pennsylvania, 16105
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, 15219
Somerset Oncology Center
Somerset, Pennsylvania, 15501
About this study
Official title: UPMC McKeesport/ROCOG Radiation Oncology Minorities Outreach Program
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.
Read the detailed description
OBJECTIVES:
- Develop, over five years, and implement a shared infrastructure that will permit participating community cancer centers to participate in radiation oncology clinical research and dramatically increase their rate of trial accrual above historical patterns.
- Increase access to radiation oncology services and clinical trials for underserved minority and/or low-income patients in the target areas, through community and professional education and outreach activities.
- Assess and ensure the quality of radiation oncology services at participating facilities through the use of a new integrated radiation oncology outcomes database and a quality assurance program, benchmarking daily practice patterns to clinical practice protocol.
- Compare treatment approaches and outcomes for cervical, colorectal, lung, prostate, breast, and head and neck cancers across racial and socioeconomic status groups.
- Conduct community intervention pilot programs that advance the understanding of factors that lead to health disparities.
- Develop and implement clinical treatment studies that attempt to reduce or eliminate health disparities through novel treatment approaches.
- Develop and refine a model program that can be sustained by the community treatment facilities long after study completion, and that the National Cancer Institute or other similarly motivated funders can replicate within other regions.
OUTLINE: This is a multicenter study.
Patients are enrolled in the Patient Navigator program, an initiative to promote equal access and quality of cancer care. Patients undergo an interview with the Patient Navigator, who is an oncology health professional, over approximately 1 hour to identify specific needs, in terms of receiving cancer care. The interview serves as a basis for developing a plan to assist patients through treatment and follow up. The Patient Navigator meets the patient, in person or over the phone, at various times during treatment to help the patient overcome barriers to completion of cancer therapy. The Patient Navigator then provides yearly follow up to facilitate continued medical follow up. Patients complete surveys before and after program participation.
Patients are followed periodically to determine their current status in cancer therapy.
TELESYNERGY®, a portable live-time interactive telemedicine system, is utilized in developing the necessary infrastructure and professional education in the community. It is used for sharing information and approaches for case presentation, treatment planning conferences, and other specialized presentations by invited speakers and expert panels. Activities using the TELESYNERGY® system are videotaped to create a library of topic-centered presentations that can be shared with the larger community. Components and summaries are placed on an Internet site to encourage communication with the larger oncology community.
PROJECTED ACCRUAL: A total of 3,150 patients will be accrued for this study.
- Conditions
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- counseling intervention, study of socioeconomic and demographic variables, psychosocial assessment and care
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
study of socioeconomic and demographic variablesOther
psychosocial assessment and careProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| REview | Other | Not described Receives: Other: counseling intervention; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical stage at time of presentation (indicator of early access to system)
Measured: Observation
Date and nature of post-diagnosis surgery or biopsy
Measured: Observation
Proportion of patients compliant with treatment plan
Measured: Observation
Total radiation dosage per patient (curative and palliative endpoints)
Measured: Observation
Supportive services provided to patients
Measured: Observation
Rate of treatment completion
Measured: Observation
Accrual for clinical research protocols
Measured: Observation
Retention in clinical research protocols
Measured: Observation
Barriers to treatment (perceived and real)
Measured: Observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2006 (estimated)
- Study startOct 2004
- Primary completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial Effects of Cancer and Its TreatmentStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Dwight Heron, University of Pittsburgh
- Investigators
- Dwight E. Heron, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400699
- Sponsor's protocol ID
- PCI-0408108
- Other IDs
- CDR0000513067
- Status last verified
- Jan 2014
- First submitted
- 16 Nov 2006
- Last updated
- 31 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPMC McKeesport/ROCOG Radiation Oncology Minorities Outreach Program
- ClinicalTrials.gov ID
- NCT00400699
- Acronym / sponsor ID
- PCI-0408108
- Conditions
- Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,150 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2004
- Primary completion
- Nov 2009 (actual)
- First posted
- 17 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Develop, over five years, and implement a shared infrastructure that will permit participating community cancer centers to participate in radiation oncology clinical research and dramatically increase their rate of trial accrual above historical patterns.
- Increase access to radiation oncology services and clinical trials for underserved minority and/or low-income patients in the target areas, through community and professional education and outreach activities.
- Assess and ensure the quality of radiation oncology services at participating facilities through the use of a new integrated radiation oncology outcomes database and a quality assurance program, benchmarking daily practice patterns to clinical practice protocol.
- Compare treatment approaches and outcomes for cervical, colorectal, lung, prostate, breast, and head and neck cancers across racial and socioeconomic status groups.
- Conduct community intervention pilot programs that advance the understanding of factors that lead to health disparities.
- Develop and implement clinical treatment studies that attempt to reduce or eliminate health disparities through novel treatment approaches.
- Develop and refine a model program that can be sustained by the community treatment facilities long after study completion, and that the National Cancer Institute or other similarly motivated funders can replicate within other regions.
OUTLINE: This is a multicenter study.
Patients are enrolled in the Patient Navigator program, an initiative to promote equal access and quality of cancer care. Patients undergo an interview with the Patient Navigator, who is an oncology health professional, over approximately 1 hour to identify specific needs, in terms of receiving cancer care. The interview serves as a basis for developing a plan to assist patients through treatment and follow up. The Patient Navigator meets the patient, in person or over the phone, at various times during treatment to help the patient overcome barriers to completion of cancer therapy. The Patient Navigator then provides yearly follow up to facilitate continued medical follow up. Patients complete surveys before and after program participation.
Patients are followed periodically to determine their current status in cancer therapy.
TELESYNERGY®, a portable live-time interactive telemedicine system, is utilized in developing the necessary infrastructure and professional education in the community. It is used for sharing information and approaches for case presentation, treatment planning conferences, and other specialized presentations by invited speakers and expert panels. Activities using the TELESYNERGY® system are videotaped to create a library of topic-centered presentations that can be shared with the larger community. Components and summaries are placed on an Internet site to encourage communication with the larger oncology community.
PROJECTED ACCRUAL: A total of 3,150 patients will be accrued for this study.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REview | Other | Other: counseling intervention, Other: study of socioeconomic and demographic variables, Procedure: psychosocial assessment and care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counseling intervention | Other | REview |
| study of socioeconomic and demographic variables | Other | REview |
| psychosocial assessment and care | Procedure or surgery | REview |
Primary outcome
Clinical stage at time of presentation (indicator of early access to system)
Time frame: Observation
Date and nature of post-diagnosis surgery or biopsy
Time frame: Observation
Proportion of patients compliant with treatment plan
Time frame: Observation
Total radiation dosage per patient (curative and palliative endpoints)
Time frame: Observation
Supportive services provided to patients
Time frame: Observation
Rate of treatment completion
Time frame: Observation
Accrual for clinical research protocols
Time frame: Observation
Retention in clinical research protocols
Time frame: Observation
Barriers to treatment (perceived and real)
Time frame: Observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dwight E. Heron, MD principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention, study of socioeconomic and demographic variables and psychosocial assessment and care in people with Psychosocial Effects of Cancer and Its Treatment and Unspecified Adult Solid Tumor, Protocol Specific, run by University of Pittsburgh at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical stage at time of presentation (indicator of early access to system) (time frame: Observation). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2014.