Symptom Clusters in Cancer Patients and Their Caregivers-... | NCT00769301

Studies
Symptom Clusters in Cancer Patients and Their Caregivers- a Longitudinal Study

NCT00769301

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Aug 7, 2018Actual

Enrollment

570Actual

Phase

Not provided

Conditions

Cancer
Pain
Fatigue
Depression
Sleeping Problems

Interventions

Not provided

Countries

Norway

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

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008Actual

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Oct 8, 2008

First Submission Date that Met QC Criteria

Oct 8, 2008

First Posted Date

Oct 9, 2008Estimated

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

Aug 5, 2018

Last Update Posted Date

Aug 7, 2018Actual

Name	Class
University of California, San Francisco	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 complexity of cancer patients' symptoms and health problems constitutes considerable distress and burden for patients and their family caregivers. To help them manage the illness effectively, there is a need to better understand the complexity of symptoms and symptom clusters in patients and caregivers. Therefore, the purpose of this research is to explore a set of important fundamental research questions to advance the scientific knowledge of cancer patients' and caregivers' symptoms, symptom clusters and health-related quality of life. The investigators will follow 500 cancer patients and their caregivers with repeated measures over 6 months to assess their symptoms, symptom clusters, and quality of life over time. Caregiver burden will also be examined in the caregivers.

Detailed Description

The specific aims of the study, where we will follow 500 cancer patients and their caregivers with repeated measures over 6 months, are to:

Explore cancer patients' symptoms, symptom clusters and symptom changes over time; and identify subgroups of patients with different symptom clusters.
Identify genomic markers for the different patient subgroups.
Explore symptoms, symptom clusters and burden in caregivers of cancer patients.
Explore relationships between patients' and caregivers' symptoms, symptom clusters, quality of life and caregiver burden.

Patients will be asked to complete questionnaires to collect demographic characteristics and self-reported medical history information, a general symptom inventory, specific measures of the symptoms of pain, sleep disturbance, fatigue, depression, functional status and quality of life. The patients' medical record will be reviewed for disease and treatment information.

The caregivers will also be asked to complete questionnaires about a general symptom inventory, specific measures of the symptoms of pain, sleep disturbance, fatigue, depression, functional status, quality of life and caregiver burden.

Data Analyses will be done to identify symptom clusters of the different symptoms, and to identify patient subgroups based on their symptom experience and quality of life. Variations in symptom clusters and quality of life over time will also be evaluated. Genetic analyses will also be done in the patients.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

570Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Not hospitalized cancer patients under active treatment
2		Caregivers of these cancer patients

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical functioning and quality of life		5 to 8 times during 6 months

Secondary Outcomes

Measure	Description	Time Frame
Symptoms will be measured both in patients and caregivers. Caregiver burden will be measured in the caregivers. A blood sample for genetic testing will be taken from the patients once		5 to 8 times during 6 months for patients. Three times during 6 months for caregivers.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria for patients are:

diagnosed with breast, colon, head and neck or ovarian cancer
receiving active treatment for their cancer (chemo- or radiation therapy)
above 18 years of age
able to read / write /speak Norwegian.

Inclusion criteria for caregivers:

above 18 years
read and speak Norwegian
and written informed consent.

Exclusion Criteria:

patients who had received radiation on the brain as this may affect their abilities to reliably complete questionnaires.

Accepts Healthy Volunteers

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

500 cancer outpatients (125 with breast cancer and 125 with head and neck cancer receiving radiation therapy and 125 ovarian cancer patients and 125 colon cancer patients receiving chemotherapy)

and their caregivers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tone Rustøen, PhD	Oslo University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset Østfold		Fredrikstad		1603	Norway
Oslo University Hopsital, Rikshospitalet

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D010146	Pain
D005221	Fatigue
D003863	Depression
D020447	Parasomnias
D007319	Sleep Initiation and Maintenance Disorders
D000084802	Caregiver Burden

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Description

DNA analyses for genotyping subgroups of patients based on their experience with pain, fatigue, sleep disturbance and depression will test the hypothesis that gene polymorphisms within the selected candidate genes will exhibit significant differences in frequency distribution among the different patient subgroups that are identified through cluster analysis.