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

Sponsor
City of Hope Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01741636
Collaborator
National Cancer Institute (NCI) (NIH)
30
Enrollment
1
Location
1
Arm
11
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Survivorship Care Planning may improve overall well-being and quality of life of colorectal and lung cancer survivors

Condition or Disease Intervention/Treatment Phase
  • Other: educational intervention
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Survivorship Care Planning in Colorectal and Lung Cancer: A Feasibility Study
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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.

Other: educational intervention
Undergo Survivorship Care Planning
Other Names:
  • intervention, educational

    • Other: questionnaire administration
    Ancillary studies

    Procedure: quality-of-life assessment
    Ancillary studies
    Other Names:
  • quality of life assessment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of attrition based on number of patients who failed to complete the two-month study [2 months]

      Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.

    2. Total retention across the two month follow-up [2 months]

      Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.

    3. Percentage of those who are qualified and agree to participate [2 months]

    4. Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration [2 months]

    5. 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 [2 months]

    6. Satisfaction with the timing, content, and delivery of the intervention [2 months]

      Quantitative and qualitative descriptive statistics will be analyzed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City of Hope Medical Center Duarte California United States 91010

    Sponsors and Collaborators

    • City of Hope Medical Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Virginia Sun, City of Hope Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    City of Hope Medical Center
    ClinicalTrials.gov Identifier:
    NCT01741636
    Other Study ID Numbers:
    • 12342
    • NCI-2012-02783
    First Posted:
    Dec 5, 2012
    Last Update Posted:
    Dec 18, 2013
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Rectal Neoplasms
    Colonic Neoplasms

    Study Results

    No Results Posted as of Dec 18, 2013