The Inland Northwest Colon Cancer Survivor's Study - Full Text View

Purpose

The overall purpose of this study is to describe the trajectory of early survivorship in individuals with colon cancer who undergo both surgical and medical management of colon cancer. The primary question is whether or not there is an interaction between type of surgery and changes in quality of life, sexual function, peripheral neuropathy, and demands of illness following curative resection and adjuvant chemotherapy.

Condition
Colon Cancer

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Self Reported Changes in Quality of Life, Sexual Function, Peripheral Neuropathy, and Demands of Illness, Following Curative Resection and Adjuvant FOLFOX Chemotherapy in Colon Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Peripheral Nerve Disorders

U.S. FDA Resources

Further study details as provided by Washington State University:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
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.
Changes 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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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.

Other Outcome Measures:

Psychometric analysis of a modified version of the Neurotoxicity Sub-scale. [ Time Frame: At the completion of the study ] [ Designated as safety issue: No ]
Psychometric analysis to evaluate the reliability and validity of the modified Neurotoxicity Sub-Scale.

Estimated Enrollment:	60
Study Start Date:	January 2013
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts
Open Resection Group Colon cancer survivors who undergo open surgical resection of their colon cancers.
Laparoscopic Resection Group Colon cancer survivors who undergo laparoscopic resection of their colon cancer
Robotic Resection Group Colon cancer survivors who undergo robotic resection of their colon cancer.

Detailed Description:

The prospective design with three cohorts of participants will describe the changes in quality of life, sexual function, peripheral neuropathy and demands of illness following curative resection and adjuvant chemotherapy (Aims 1-4). An analysis of the interaction between time (four measurement occasions) and surgical type (open resection, laparoscopic resection, robotic resection) by mean values of quality of life, sexual function, peripheral neuropathy, and demands of illness will examine the central thesis question (Aim 5).

Specific Aims

Describe the demographic and disease characteristics of the sample.
Examine the relationships among quality of life, sexual functioning, peripheral neuropathy, and demands of illness for the sample-as-a-whole and by type of surgical resection (open, laparoscopic, robotic).
Examine within-subject changes in the mean values of scores for quality of life, sexual functioning, peripheral neuropathy, and demands of illness across four measurement occasions.
Examine between-group differences in mean values of scores for quality of life, sexual function, peripheral neuropathy, and demands of illness at four discrete measurement occasions.
Examine the interaction between time (four measurement occasions) and surgical type (open resection, laparoscopic resection, robotic resection) by mean values of quality of life, sexual function, peripheral neuropathy, and demands of illness.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01775254

Contacts

Contact: Jeanne M Robison, MN, ARNP	509-475-6502	jeanne.robison@email.wsu.edu
Contact: Mel Haberman, PhD, FAAN	509-324-7358	mel.haberman@wsu.edu

Locations

United States, Washington
Sacred Heart Medical Center	Recruiting
Spokane, Washington, United States, 99204
Contact: Jeanne M Robison, ARNP 509-475-6502 jeanne.robison@email.wsu.edu
Sub-Investigator: Jeanne M Robison, ARNP
Deaconess Hospital	Recruiting
Spokane, Washington, United States, 99204
Contact: Jeanne M Robison, ARNP 509-475-6502 jeanne.robison@email.wsu.edu
Sub-Investigator: Jeanne M Robison, ARNP
Holy Family Hospital	Recruiting
Spokane, Washington, United States, 99208
Contact: Jeanne M Robison, ARNP 509-476-6502 jeanne.robison@email.wsu.edu
Sub-Investigator: Jeanne M Robison, ARNP
Valley Hospital	Recruiting
Spokane, Washington, United States, 99216
Contact: Jeanne M Robison, ARNP 509-475-6502 jeanne.robison@email.wsu.edu
Principal Investigator: Jeanne M Robison, ARNP

Sponsors and Collaborators

Washington State University

American Cancer Society, Inc.

Investigators

Principal Investigator:	Jeanne M Robison, MN, ARNP	Washington State University, College of Nursing
Principal Investigator:	Mel Haberman, PhD, FAAN	Washington State University, College of Nursing

More Information

No publications provided

Responsible Party:	Washington State University
ClinicalTrials.gov Identifier:	NCT01775254 History of Changes
Other Study ID Numbers:	DSCN-11-194-01
Study First Received:	January 23, 2013
Last Updated:	January 31, 2013
Health Authority:	United States: Institutional Review Board

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:

Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

Colonic Diseases
Peripheral Nervous System Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013