The Inland Northwest Colon Cancer Survivor's Study

Sponsor

Washington State University (Other)

Overall Status

Completed

CT.gov ID

NCT01775254

Collaborator

American Cancer Society, Inc. (Other)

Enrollment

Locations

71.1

Duration (Months)

6.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Examine the relationships among quality of life, demands of illness, sexual functioning, and peripheral neuropathy, for the total sample and by chemotherapy group.
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 Design

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 :

Jan 1, 2013

Actual Primary Completion Date :

Oct 15, 2015

Actual Study Completion Date :

Dec 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Change in Quality of Life [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

Change in Peripheral Neuropathy [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 [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 [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 [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

Psychometric analysis of a modified version of the Neurotoxicity Sub-scale. [At the completion of the study]
Psychometric analysis to evaluate the reliability and validity of the modified Neurotoxicity Sub-Scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Deaconess Hospital	Spokane	Washington	United States	99204
2	Sacred Heart Medical Center	Spokane	Washington	United States	99204
3	Holy Family Hospital	Spokane	Washington	United States	99208
4	Valley Hospital	Spokane	Washington	United States	99216

Sponsors and Collaborators

Washington State University
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