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

Primary Purpose

Stage I Colon Cancer, Stage I Rectal Cancer, Stage IA Non-small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
educational intervention
questionnaire administration
quality-of-life assessment
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stage I Colon Cancer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (survivorship plan)

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 3, 2012
Last Updated
December 16, 2013
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01741636
Brief Title
Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer
Official Title
Survivorship Care Planning in Colorectal and Lung Cancer: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (survivorship plan)
Arm Type
Experimental
Arm Description
Patients undergo Survivorship Care Planning comprising disease surveillance, management of potential long-term and late effects, psycho-social-spiritual issues, and healthy living recommendations.
Intervention Type
Other
Intervention Name(s)
educational intervention
Other Intervention Name(s)
intervention, educational
Intervention Description
Undergo Survivorship Care Planning
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Percentage of attrition based on number of patients who failed to complete the two-month study
Description
Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.
Time Frame
2 months
Title
Total retention across the two month follow-up
Description
Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.
Time Frame
2 months
Title
Percentage of those who are qualified and agree to participate
Time Frame
2 months
Title
Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration
Time Frame
2 months
Title
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
Title
Satisfaction with the timing, content, and delivery of the intervention
Description
Quantitative and qualitative descriptive statistics will be analyzed.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Sun
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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