NCT00684801

Brief Summary

RATIONALE: A disease management program may be more effective than standard therapy in improving quality of life and controlling symptoms in patients with cancer. PURPOSE: This clinical trial is studying a disease management program to see how well it works compared with usual care in patients with stage III or stage IV lung cancer, stage III or stage IV pancreatic cancer, stage III or stage IV ovarian cancer, or stage III or stage IV colorectal cancer, and their caregivers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
605

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

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

August 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

4.3 years

First QC Date

May 23, 2008

Last Update Submit

October 8, 2015

Conditions

Colorectal CancerLung CancerOvarian CancerPancreatic Cancer

Keywords

recurrent non-small cell lung cancerrecurrent small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerextensive stage small cell lung cancerrecurrent pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancerrecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorstage III ovarian epithelial cancerstage III ovarian germ cell tumorstage IV ovarian epithelial cancerstage IV ovarian germ cell tumorrecurrent colon cancerstage III colon cancerstage IV colon cancerrecurrent rectal cancerstage III rectal cancerstage IV rectal cancer

Outcome Measures

Primary Outcomes (9)

  • Patient resource use

    at the end of the patient's participation in the study and via monthly hospital and clinical chart review.

  • Symptoms

    Patients and caregivers are interviewed at baseline, 3, 9, and 15 months

  • Quality of life

    Patients and caregivers are interviewed at baseline, 3, 9, and 15 months

  • Proportion of patients meeting expectations regarding care and treatment

    Patients and caregivers are interviewed at baseline, 3, 9, and 15 months

  • Patient spiritual well-being

    Patients and caregivers are interviewed at baseline, 3, 9, and 15 months

  • Caregiver mood state

    Patients and caregivers are interviewed at baseline, 3, 9, and 15 months

  • Caregiver burden

    Patients and caregivers are interviewed at baseline, 3, 9, and 15 months

  • Proportion of caregivers meeting expectations regarding care and treatment

    Patients and caregivers are interviewed at baseline, 3, 9, and 15 months

  • Caregiver's satisfaction with end-of-life care

    caregiver is interviewed at 2 months after death.

Study Arms (2)

Usual care (control group)

Patients undergo usual care as determined by core cancer team.

Other: questionnaire administrationProcedure: quality-of-life assessment

DMP (experimental group)

Patients undergo a systematic approach regarding specific domains related to their disease focusing on supportive care and symptom management determined by a multidisciplinary team of providers to help patients and caregivers manage.

Other: questionnaire administrationProcedure: quality-of-life assessment

Interventions

questionnaire administrationOTHER

Patients complete questionnaires.

DMP (experimental group)Usual care (control group)
quality-of-life assessmentPROCEDURE

Patients undergo quality-of-life assessments.

DMP (experimental group)Usual care (control group)

Eligibility Criteria

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

primary care clinic

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of 1 of the following: * Lung cancer * Pancreatic cancer * Ovarian cancer * Colorectal cancer * Stage III or IV disease * Receiving care at the Ireland Cancer Center PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Life expectancy ≥ 3 months * No cognitive impairment * May not transfer care out of geographic area * Must have caregiver available to participate PRIOR CONCURRENT THERAPY: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Daly BJ, Douglas SL, Gunzler D, Lipson AR. Clinical trial of a supportive care team for patients with advanced cancer. J Pain Symptom Manage. 2013 Dec;46(6):775-84. doi: 10.1016/j.jpainsymman.2012.12.008. Epub 2013 Mar 22.

    PMID: 23523362DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsLung NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaCarcinoma, Ovarian EpithelialColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Barbara Daly, PhD, RN

    Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 23, 2008

First Posted

May 28, 2008

Study Start

August 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 9, 2015

Record last verified: 2015-10

Locations

US(1)