Chemoradiation-Induced Nausea and Emesis: Quality of Life | NCT00394602

Studies
Chemoradiation-Induced Nausea and Emesis: Quality of Life

NCT00394602

Sponsor

M.D. Anderson Cancer Center

Status

Terminated

Last Update Posted

Jan 2, 2020Actual

Enrollment

207Actual

Phase

Not provided

Conditions

Gastric Cancer
Pancreatic Cancer
Cervical Cancer
Vulvar Cancer
Endometrial Cancer
Anal Cancer

Interventions

Interview
Questionnaire

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Requested by PI during yearly Continuing Review

Expanded Access Info

Start Date

Apr 7, 2004Actual

Primary Completion Date

May 8, 2019Actual

Completion Date

May 8, 2019Actual

First Submitted Date

Oct 30, 2006

First Submission Date that Met QC Criteria

Oct 30, 2006

First Posted Date

Nov 1, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2019

Last Update Posted Date

Jan 2, 2020Actual

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objectives of this study are:

To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
1. To compare preferences of cancer patients to those of healthy individuals.
2. To compare how patients' preferences for side-effects of chemoradiation change over time.
To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
To determine the impact of nausea and vomiting associated with chemoradiation on patients' quality of life and evaluate potential change throughout the duration of chemoradiation treatment.

Detailed Description

You will be interviewed about your perceptions of side effects that are related to your chemoradiation treatment. The interview will take about 20 minutes. You will be interviewed at the beginning of your chemoradiation treatment, 3 weeks after treatment starts, and at the first follow-up appointment after chemoradiation treatment ends.

Chemoradiation is a type of cancer treatment that involves both chemotherapy and radiation therapy.

You will also receive a packet of 3 questionnaires to complete at different times during and after treatment. The questionnaires include a quality of life survey that asks about physical, social, and emotional well-being, a self-report symptom evaluation that will ask whether you are experiencing any particular side effects and if so how much it bothers you, and a brief survey to asks questions about anxiety and distress.

The questionnaires should take about 20 minutes each to complete. The questionnaire packet will be given to patients at the beginning of chemoradiation treatment, 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends. If the you do not have time to complete the questionnaires, a stamped, addressed envelop will be given so that you can mail the completed packet back to the research team.

Your participation in this research study will be over about 4-6 weeks after chemoradiation treatment ends.

This is an investigational study. Up to 208 individuals (104 patients and 104 caregivers) will take part in this study. All will be enrolled at M. D. Anderson.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Patients receiving chemoradiation for abdominal-pelvic tumors.	Behavioral: Interview Other: Questionnaire
Caregiver Controls		Healthy controls with no prior cancer diagnosis.	Behavioral: Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interview	Behavioral	Interview regarding perceptions of side effects that are related to chemoradiation treatment.	Caregiver Controls Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Longitudinal Quality of Life + Symptom Assessment Data	Quality of life survey instruments scored according to EORTC QLQ-C30 scoring manual. Patients and controls compared with respect to preference data. The control group preference data collected at only 1 time point, but patient preference data from each time point will be compared to these control group preference data.	Survey(s) & Interview(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients receiving 5 to 6-week course of chemoradiation for abdominal-pelvic tumors (gastric cancers, gastro-esophageal (GE) junction, pancreatic, cervix, vulvar, endometrial, or anal) using conventional fractionation [(180cGy-200cGy per day)]
Patients receiving concurrent abdominal-pelvic radiation and single agent or combination of cisplatin, paclitaxel, CPT-11, oxaliplatin or 5-FU, capecitabine, gemcitabine, or bevacizumab (Avastin).
Patients must be least 18 years of age
Controls must be individuals with no prior cancer diagnosis
Controls must be at least 18 years of age
Controls must be the caregivers of patients on this study

Exclusion Criteria:

Patients who do not have a diagnosis of cervix, endometrial, vulvar or anal cancer
Patients who are not scheduled to receive chemoradiation treatment
Patients who are not at least 18 years of age
Controls - individuals who have a prior diagnosis of cancer (with the exception of non-melanoma skin cancer)
Controls - individuals who are not at least 18 years of age

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving chemoradiation for abdominal-pelvic tumors and healthy controls.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlotte C. Sun, MD	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas MD Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
University of Texas MD Anderson Cancer Center Website	View source

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D010190	Pancreatic Neoplasms
D002583	Uterine Cervical Neoplasms
D014846	Vulvar Neoplasms
D016889	Endometrial Neoplasms
D001005	Anus Neoplasms
D014839	Vomiting
D009325	Nausea

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007407	Interviews as Topic
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided