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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01741636
First received: December 3, 2012
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
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
Other: educational intervention
Other: questionnaire administration
Procedure: quality-of-life assessment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Survivorship Care Planning in Colorectal and Lung Cancer: A Feasibility Study

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Percentage of attrition based on number of patients who failed to complete the two-month study [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Satisfaction with the timing, content, and delivery of the intervention [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Quantitative and qualitative descriptive statistics will be analyzed.


Enrollment: 30
Study Start Date: January 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: intervention, educational
Other: questionnaire administration
Ancillary studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741636

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Principal Investigator: Virginia Sun City of Hope Medical Center
  More Information

No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT01741636     History of Changes
Other Study ID Numbers: 12342, NCI-2012-02783
Study First Received: December 3, 2012
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014