NCT01741636

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

December 3, 2012

Last Update Submit

December 16, 2013

Conditions

Stage I Colon CancerStage I Rectal CancerStage IA Non-small Cell Lung CancerStage IB Non-small Cell Lung CancerStage IIA Colon CancerStage IIA Non-small Cell Lung CancerStage IIA Rectal CancerStage IIB Colon CancerStage IIB Non-small Cell Lung CancerStage IIB Rectal CancerStage IIC Colon CancerStage IIC Rectal CancerStage IIIA Colon CancerStage IIIA Non-small Cell Lung CancerStage IIIA Rectal CancerStage IIIB Colon CancerStage IIIB Non-small Cell Lung CancerStage IIIB Rectal CancerStage IIIC Colon CancerStage IIIC Rectal Cancer

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (1)

Supportive care (survivorship plan)

EXPERIMENTAL

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 interventionOther: questionnaire administrationProcedure: quality-of-life assessment

Interventions

educational interventionOTHER

Undergo Survivorship Care Planning

Also known as: intervention, educational
Supportive care (survivorship plan)
questionnaire administrationOTHER

Ancillary studies

Supportive care (survivorship plan)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Supportive care (survivorship plan)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Early Intervention, EducationalMethods

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesInvestigative Techniques

Study Officials

  • Virginia Sun

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 5, 2012

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

US(1)