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The Inland Northwest Colon Cancer Survivor's Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date January 23, 2013
First Posted Date January 24, 2013
Last Update Posted Date December 6, 2018
Study Start Date January 2013
Actual Primary Completion Date October 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2018)
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
Original Primary Outcome Measures
 (submitted: January 23, 2013)
Quality of Life [ Time Frame: Four measurements occasions over 38 weeks (Before surgery, 4-6 weeks after surgery, 20-22 weeks after surgery and 32-36 weeks after surgery) ]
The European Organization for Research and Treatment Quality of Life Questionnaire (EORTC-QLQ-C-30) and colon cancer specific module (QLQ-CR-29)will be utilized to measure changes in quality of life. The interaction between time (four measurement occasions) and surgical type (open resection, laparoscopic resection, robotic resection) by mean values of quality of life will be examined.
Change History Complete list of historical versions of study NCT01775254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 4, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: January 23, 2013)
  • Peripheral Neuropathy [ Time Frame: Four measurements occasions over 38 weeks (Before surgery, 4-6 weeks after surgery, 20-22 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 surgical type (open resection, laparoscopic resection, robotic resection) by mean values of peripheral neuropathy will be examined.
  • Change in Sexual Function [ Time Frame: Four measurements occasions over 38 weeks (Before surgery, 4-6 weeks after surgery, 20-22 weeks after surgery and 32-36 weeks after surgery) ]
    The Changes 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 surgical type (open resection, laparoscopic resection, robotic resection) by mean values of changes in sexual function will be examined.
  • Demands of Illness [ Time Frame: Four measurements occasions over 38 weeks (Before surgery, 4-6 weeks after surgery, 20-22 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 surgical type (open resection, laparoscopic resection, robotic resection) by mean values from the demands of illness inventory will be examined.
  • Patient Education and Support [ Time Frame: Four measurements occasions over 38 weeks (Before surgery, 4-6 weeks after surgery, 20-22 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 58 weeks after diagnosis.
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2013)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Inland Northwest Colon Cancer Survivor's Study
Official Title Self Reported Changes in Quality of Life, Demands of Illness, and Sexual Function in Colon Cancer Survivors.
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?
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Colon Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 4, 2018)
25
Original Estimated Enrollment
 (submitted: January 23, 2013)
60
Actual Study Completion Date December 4, 2018
Actual Primary Completion Date October 15, 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01775254
Other Study ID Numbers DSCN-11-194-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Washington State University
Study Sponsor Washington State University
Collaborators American Cancer Society, Inc.
Investigators
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
PRS Account Washington State University
Verification Date December 2018