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The Inland Northwest Colon Cancer Survivor's Study

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ClinicalTrials.gov Identifier: NCT01775254
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Washington State University

Brief Summary:
The overall purpose of this study was to address the following questions by describing the trajectory of early survivorship in individuals who undergo both surgical and medical management of colon cancer. What are the changes in quality of life, demands of illness, sexual function, and peripheral neuropathy, following curative resection during the first year of treatment and recovery? Is there an interaction between exposures to chemotherapy and changes over time in these outcomes?

Condition or disease
Colon Cancer

Detailed Description:

The population of interest included colon cancer survivors of both sexes, 18 to 90 years of age, who underwent one of two types of surgical resection and who may receive adjuvant chemotherapy. The prospective design with two cohorts representing exposure to chemotherapy (chemotherapy vs. no-chemotherapy) described the changes in quality of life, demands of illness, sexual function, and peripheral neuropathy, which occurred following curative resection. An analysis of the interaction between time (four measurement occasions) and the independent variable of chemotherapy group by mean values of quality of life, sexual function, peripheral neuropathy, and demands of illness addressed the central thesis question.

Specific Aims

  1. Examine the relationships among quality of life, demands of illness, sexual functioning, and peripheral neuropathy, for the total sample and by chemotherapy group.
  2. Examine changes within-subjects (four measurement occasions), between-group (chemotherapy, no-chemotherapy) differences, and the interaction between time and chemotherapy group for quality of life, demands of illness, sexual functioning, and peripheral neuropathy across four measurement occasions.

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Self Reported Changes in Quality of Life, Demands of Illness, and Sexual Function in Colon Cancer Survivors.
Study Start Date : January 2013
Actual Primary Completion Date : October 15, 2015
Actual Study Completion Date : December 4, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Chemotherapy Group
Colon cancer survivors who undergo open or laparoscopic resection of their colon cancers followed by adjuvant chemotherapy.
No Chemotherapy Group
Colon cancer survivors who undergo open or laparoscopic resection of their colon cancer and who do not receive chemotherapy.



Primary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery) ]
    The European Organization for Research and Treatment Quality of Life Questionnaire


Secondary Outcome Measures :
  1. Change in Peripheral Neuropathy [ Time Frame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery) ]
    The Neurotoxicity Sub-scale (Ntx-13); a questionnaire about symptoms of nerve damage in persons receiving chemotherapy, will be utilized to assess symptoms of neurologic toxicities in persons receiving the chemotherapy drug oxaliplatin. The interaction between time (four measurement occasions) and chemotherapy group (chemotherapy, no chemotherapy ) by mean values of peripheral neuropathy will be examined.

  2. Change in Sexual Function [ Time Frame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery) ]
    Change in Sexual Function Questionnaire (CSFQ)will be used to describe the changes in sexual function reported by cancer survivors following surgery and adjuvant chemotherapy. The interaction between time (four measurement occasions) and chemotherapy group (chemotherapy, no chemotherapy ) by mean values of changes in sexual function will be examined.

  3. Change in Patient Education and Support Utilized [ Time Frame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery) ]
    A short questionnaire regarding the use of educational and support materials related to colon cancer will be used to describe which materials persons with colon cancer utilize during the 8 months after diagnosis.

  4. Change in Demands of Illness [ Time Frame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery) ]
    The Demands of Illness Inventory (DOII); a questionnaire about the stressors experienced by cancer survivors will be utilized for this outcome measure. The interaction between time (four measurement occasions) and chemotherapy group (chemotherapy, no chemotherapy ) by mean values from the demands of illness inventory will be examined.


Other Outcome Measures:
  1. Psychometric analysis of a modified version of the Neurotoxicity Sub-scale. [ Time Frame: At the completion of the study ]
    Psychometric analysis to evaluate the reliability and validity of the modified Neurotoxicity Sub-Scale.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons newly diagnosed with colon cancer anticipated to undergo curative resection. To include those who will receive adjuvant FOLFOX chemotherapy.
Criteria

Inclusion Criteria:

  • Male or Female at least 18 years of age
  • Biopsy Proven Colon Cancer
  • Plan to undergo open, laparoscopic or robotic surgical colectomy.

Exclusion Criteria:

  • Persons with rectal cancer
  • Surgical resection below the rectal sigmoid junction
  • Does not speak or read English
  • Scheduled to receive radiation therapy during the data collection period
  • Diagnosis of metastatic colon cancer (Stage IV)
  • A previous history of cancer diagnosed with the past five years with the exception of early basal cell or squamous skin cancer or early stage melanoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775254


Locations
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United States, Washington
Deaconess Hospital
Spokane, Washington, United States, 99204
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Holy Family Hospital
Spokane, Washington, United States, 99208
Valley Hospital
Spokane, Washington, United States, 99216
Sponsors and Collaborators
Washington State University
American Cancer Society, Inc.
Investigators
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Principal Investigator: Jeanne M Robison, PhD, ARNP Washington State University, College of Nursing
Principal Investigator: Mel Haberman, PhD, FAAN Washington State University, College of Nursing

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Responsible Party: Washington State University
ClinicalTrials.gov Identifier: NCT01775254     History of Changes
Other Study ID Numbers: DSCN-11-194-01
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Washington State University:
Colon Cancer
FOLFOX
Laparoscopic Colectomy
Open Colectomy
Robotic Colectomy
Quality of Life
Sexual Function
Peripheral Neuropathy
Demands of Illness
Cancer Survivor

Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases