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

Stage IIIB Non-small Cell Lung Cancer Clinical Trial

Official title:

Survivorship Care Planning in Colorectal and Lung Cancer: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741636
• Other study ID #: 12342
• Secondary ID: NCI-2012-02783
• Status: Completed
• Phase: N/A
• First received: December 3, 2012
• Last updated: December 16, 2013
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Rectal Neoplasms
• 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

Other:
• educational intervention
Undergo Survivorship Care Planning
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of attrition based on number of patients who failed to complete the two-month study	Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.	2 months	No
Primary	Total retention across the two month follow-up	Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.	2 months	No
Primary	Percentage of those who are qualified and agree to participate		2 months	No
Primary	Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration		2 months	No
Primary	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	No
Primary	Satisfaction with the timing, content, and delivery of the intervention	Quantitative and qualitative descriptive statistics will be analyzed.	2 months	No