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Advancing the Science of Symptom Management and Support for Cancer Patients and Their Caregivers


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer, Pain, Fatigue, Depression, Sleeping Problems

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Trial Information

Advancing the Science of Symptom Management and Support for Cancer Patients and Their Caregivers


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

1. Explore cancer patients' symptoms, symptom clusters and symptom changes over time; and
identify subgroups of patients with different symptom clusters.

2. Identify genomic markers for the different patient subgroups.

3. Explore symptoms, symptom clusters and burden in caregivers of cancer patients.

4. 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.

Inclusion 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Physical functioning and quality of life

Outcome Time Frame:

5 to 8 times during 6 months

Safety Issue:

No

Principal Investigator

Tone Rust√łen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital

Authority:

Norway: Data Protection Authority

Study ID:

154-08158d

NCT ID:

NCT00769301

Start Date:

November 2008

Completion Date:

December 2014

Related Keywords:

  • Cancer
  • Pain
  • Fatigue
  • Depression
  • Sleeping Problems
  • Symptoms
  • pain
  • fatigue
  • depression
  • sleeplessness
  • genetic markers
  • caregiver burden.
  • Depression
  • Depressive Disorder
  • Fatigue
  • Syndrome

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