Clinical trial NCT01741636: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Percentage of attrition based on number of patients who failed to complete the two-month study
timeFrame: 2 months
measure: Total retention across the two month follow-up
timeFrame: 2 months
measure: Percentage of those who are qualified and agree to participate
timeFrame: 2 months
measure: Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration
timeFrame: 2 months
measure: 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
timeFrame: 2 months
measure: Satisfaction with the timing, content, and delivery of the intervention
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Virginia Sun
role: PRINCIPAL_INVESTIGATOR
References: