Survivorship Care Planning in Patients With Colorectal or Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified January 2013 by City of Hope Medical Center
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01741636
First received: December 3, 2012
Last updated: January 30, 2013
Last verified: January 2013
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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.
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | January 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741636
Locations
| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Virginia Sun 800-826-4673 vsun@coh.org | |
| Principal Investigator: Virginia Sun | |
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: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Colonic Neoplasms Rectal Neoplasms Lung Neoplasms 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 May 16, 2013