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Completed

NCT Number: NCT01741636

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

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

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Key information

Conditions

Stage I Colon Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms 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 Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Undergo Survivorship Care Planning

Other names: intervention, educational

Questionnaire Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Primary outcomes

  1. Percentage of attrition based on number of patients who failed to complete the two-month study

    Time frame: 2 months

    Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.

  2. Total retention across the two month follow-up

    Time frame: 2 months

    Descriptive statistics will be presented on those who agree to participate and the proportion of those approached who agree to participate.

  3. Percentage of those who are qualified and agree to participate

    Time frame: 2 months

  4. Data collection protocols including who will administer the survey, timing of surveys, telephone interviews vs. face to face administration

    Time frame: 2 months

  5. 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

  6. Satisfaction with the timing, content, and delivery of the intervention

    Time frame: 2 months

    Quantitative and qualitative descriptive statistics will be analyzed.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2012
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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