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

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

Detailed Description
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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.

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

Conditions
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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 / Treatment
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* Other: educational intervention
* Other: questionnaire administration
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (survivorship plan)<br>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<br>* Undergo Survivorship Care Planning<br>* Other names: intervention, educational;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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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 |