Clinical trial NCT01775254: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: Colon Cancer
FOLFOX
Laparoscopic Colectomy
Open Colectomy
Robotic Colectomy
Quality of Life
Sexual Function
Peripheral Neuropathy
Demands of Illness
Cancer Survivor
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2013-01-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Change in Quality of Life
timeFrame: 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 outcomes:
measure: Change in Peripheral Neuropathy
timeFrame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
measure: Change in Sexual Function
timeFrame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
measure: Change in Patient Education and Support Utilized
timeFrame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
measure: Change in Demands of Illness
timeFrame: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
Other outcomes:
measure: Psychometric analysis of a modified version of the Neurotoxicity Sub-scale.
timeFrame: At the completion of the study
Locations:
city: Spokane
country: United States
facility: Deaconess Hospital
state: Washington
city: Spokane
country: United States
facility: Sacred Heart Medical Center
state: Washington
city: Spokane
country: United States
facility: Holy Family Hospital
state: Washington
city: Spokane
country: United States
facility: Valley Hospital
state: Washington
Study officials:
affiliation: Washington State University, College of Nursing
name: Jeanne M Robison, PhD, ARNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington State University, College of Nursing
name: Mel Haberman, PhD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: