Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Cancer Society, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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?
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Persons newly diagnosed with colon cancer anticipated to undergo curative resection. To include those who will receive adjuvant FOLFOX chemotherapy.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeanne M Robison, PhD, ARNP | Washington State University, College of Nursing | Principal Investigator |
| Mel Haberman, PhD, FAAN | Washington State University, College of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deaconess Hospital | Spokane | Washington | 99204 | United States | ||
| Sacred Heart Medical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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) |
| 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) |
| 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) |
| Spokane |
| Washington |
| 99204 |
| United States |
| Holy Family Hospital | Spokane | Washington | 99208 | United States |
| Valley Hospital | Spokane | Washington | 99216 | United States |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |