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Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01741636
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : December 18, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE December 3, 2012
First Posted Date  ICMJE December 5, 2012
Last Update Posted Date December 18, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2012)
  • Percentage of attrition based on number of patients who failed to complete the two-month study [ Time Frame: 2 months ]
    Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.
  • Total retention across the two month follow-up [ Time Frame: 2 months ]
    Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.
  • Percentage of those who are qualified and agree to participate [ Time Frame: 2 months ]
  • Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration [ Time Frame: 2 months ]
  • Cost implications including hiring and training of the research staff, development of study manuals and patient education materials, research staff time, intervention supplies, and other miscellaneous costs [ Time Frame: 2 months ]
  • Satisfaction with the timing, content, and delivery of the intervention [ Time Frame: 2 months ]
    Quantitative and qualitative descriptive statistics will be analyzed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer
Official Title  ICMJE Survivorship Care Planning in Colorectal and Lung Cancer: A Feasibility Study
Brief Summary Survivorship Care Planning may improve overall well-being and quality of life of colorectal and lung cancer survivors
Detailed Description

PRIMARY OBJECTIVES:

I. To test the feasibility and acceptability of an Advanced Practice Nurse (APN) driven Survivorship Care Planning (SCP) intervention for colorectal cancer (CRC) and non-small cell lung cancer (NSCLC) survivors.

SECONDARY OBJECTIVES:

I. Development of the infrastructure and strategy for a larger comparative intervention study.

OUTLINE:

Patients undergo Survivorship Care Planning comprising disease surveillance, management of potential long-term and late effects, psycho-social-spiritual issues, and healthy living recommendations.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Stage I Colon Cancer
  • Stage I Rectal Cancer
  • Stage IA Non-small Cell Lung Cancer
  • Stage IB Non-small Cell Lung Cancer
  • Stage IIA Colon Cancer
  • Stage IIA Non-small Cell Lung Cancer
  • Stage IIA Rectal Cancer
  • Stage IIB Colon Cancer
  • Stage IIB Non-small Cell Lung Cancer
  • Stage IIB Rectal Cancer
  • Stage IIC Colon Cancer
  • Stage IIC Rectal Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Non-small Cell Lung Cancer
  • Stage IIIA Rectal Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Non-small Cell Lung Cancer
  • Stage IIIB Rectal Cancer
  • Stage IIIC Colon Cancer
  • Stage IIIC Rectal Cancer
Intervention  ICMJE
  • Other: educational intervention
    Undergo Survivorship Care Planning
    Other Name: intervention, educational
  • Other: questionnaire administration
    Ancillary studies
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
Study Arms  ICMJE Experimental: Supportive care (survivorship plan)
Patients undergo Survivorship Care Planning comprising disease surveillance, management of potential long-term and late effects, psycho-social-spiritual issues, and healthy living recommendations.
Interventions:
  • Other: educational intervention
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically confirmed diagnosis of stage I, II, or III CRC or NSCLC
  • Able to read and understand English
  • Able to read and/or understand the study protocol requirements, and provide written informed consent
  • Diagnosis of CRC or NSCLC
  • Within three months of completing primary treatment (surgery, chemotherapy, radiation, or chemoradiation)
  • Without recurrent or new primary cancers
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01741636
Other Study ID Numbers  ICMJE 12342
NCI-2012-02783 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Virginia Sun City of Hope Medical Center
PRS Account City of Hope Medical Center
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP