The Inland Northwest Colon Cancer Survivor's Study

Colon Cancer Clinical Trial

Official title:

Self Reported Changes in Quality of Life, Demands of Illness, and Sexual Function in Colon Cancer Survivors.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775254
• Other study ID #: DSCN-11-194-01
• Status: Completed
• Start date: January 2013
• Est. completion date: December 4, 2018

Study information

• Verified date: December 2018
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 4, 2018
• Est. primary completion date: October 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Locations

Country	Name	City	State
United States	Deaconess Hospital	Spokane	Washington
United States	Holy Family Hospital	Spokane	Washington
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Valley Hospital	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychometric analysis of a modified version of the Neurotoxicity Sub-scale.	Psychometric analysis to evaluate the reliability and validity of the modified Neurotoxicity Sub-Scale.	At the completion of the study
Primary	Change in Quality of Life	The European Organization for Research and Treatment Quality of Life Questionnaire	Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
Secondary	Change in Peripheral Neuropathy	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.	Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
Secondary	Change in Sexual Function	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.	Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
Secondary	Change in Patient Education and Support Utilized	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.	Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
Secondary	Change in Demands of Illness	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.	Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)