NCT01775254

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2015

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

December 6, 2018

Status Verified

December 1, 2018

Enrollment Period

2.8 years

First QC Date

January 23, 2013

Last Update Submit

December 4, 2018

Conditions

Colon Cancer

Keywords

Colon CancerFOLFOXLaparoscopic ColectomyOpen ColectomyRobotic ColectomyQuality of LifeSexual FunctionPeripheral NeuropathyDemands of IllnessCancer Survivor

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (4)

  • 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)

  • 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 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)

  • 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)

Other Outcomes (1)

  • Psychometric analysis of a modified version of the Neurotoxicity Sub-scale.

    At the completion of the study

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons newly diagnosed with colon cancer anticipated to undergo curative resection. To include those who will receive adjuvant FOLFOX chemotherapy.

You may qualify if:

  • Male or Female at least 18 years of age
  • Biopsy Proven Colon Cancer
  • Plan to undergo open, laparoscopic or robotic surgical colectomy.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Deaconess Hospital

Spokane, Washington, 99204, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Holy Family Hospital

Spokane, Washington, 99208, United States

Location

Valley Hospital

Spokane, Washington, 99216, United States

Location

MeSH Terms

Conditions

Colonic NeoplasmsPeripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2013

First Posted

January 24, 2013

Study Start

January 1, 2013

Primary Completion

October 15, 2015

Study Completion

December 4, 2018

Last Updated

December 6, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(4)