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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer

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Trial Information

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


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

1. Describe the demographic and disease characteristics of the sample.

2. 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).

3. 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.

4. 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.

5. 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Quality of Life

Outcome Description:

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.

Outcome 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)

Safety Issue:

No

Principal Investigator

Jeanne M Robison, MN, ARNP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington State University, College of Nursing

Authority:

United States: Institutional Review Board

Study ID:

DSCN-11-194-01

NCT ID:

NCT01775254

Start Date:

January 2013

Completion Date:

June 2015

Related Keywords:

  • Colon Cancer
  • Colon Cancer
  • FOLFOX
  • Laparoscopic Colectomy
  • Open Colectomy
  • Robotic Colectomy
  • Quality of Life
  • Sexual Function
  • Peripheral Neuropathy
  • Demands of Illness
  • Cancer Survivor
  • Colonic Neoplasms
  • Peripheral Nervous System Diseases

Name

Location

Sacred Heart Medical CenterSpokane, Washington  99204
Holy Family HospitalSpokane, Washington  99207
Deaconess HospitalSpokane, Washington  99204
Valley HospitalSpokane, Washington  99216