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

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

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

Study Overview

• Status: Completed
• Conditions: Stage IIA Rectal Cancer; Stage IIB Rectal Cancer; Stage IIC Rectal Cancer; Stage IIIA Rectal Cancer; Stage IIIB Rectal Cancer; Stage IIIC Rectal Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IIIA Colon Cancer; Stage IIIB Colon Cancer; Stage IIIC Colon Cancer; Stage I Colon Cancer; Stage I Rectal Cancer; Stage IIA Colon Cancer; Stage IIB Colon Cancer; Stage IIC Colon Cancer; Stage IA Non-small Cell Lung Cancer; Stage IB Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: educational intervention

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: educational intervention; Undergo Survivorship Care Planning; Other Names: intervention, educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Percentage of those who are qualified and agree to participate		2 months
Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration		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		2 months
Satisfaction with the timing, content, and delivery of the intervention	Quantitative and qualitative descriptive statistics will be analyzed.	2 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 18, 2013
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: 12342; NCI-2012-02783 (Registry Identifier: CTRP (Clinical Trial Reporting Program))