CancerNCT00769301
Symptom Clusters in Cancer Patients and Their Caregivers- a Longitudinal Study
An observational study of Cancer and Pain, run by Oslo University Hospital at 3 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 570 participants
- Where
- 3 sitesNorway
- Study dates
- Nov 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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.
- above 18 years
- read and speak Norwegian
- and written informed consent.
Who cannot join
- patients who had received radiation on the brain as this may affect their abilities to reliably complete questionnaires.
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Sykehuset Østfold
Fredrikstad, 1603
Oslo University Hopsital, Rikshospitalet
Oslo, 0027
Rikshospitalet
Oslo, 0027
About this study
Official title: Advancing the Science of Symptom Management and Support for Cancer Patients and Their Caregivers
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.
Read the 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.
- Conditions
- Cancer, Pain, Fatigue, Depression, Sleeping Problems
- Keywords
- Symptoms, pain, fatigue, depression, sleeplessness, genetic markers, caregiver burden.
- Medical subject headings
- Neoplasms, Pain, Fatigue, Depression, Parasomnias, Sleep Initiation and Maintenance Disorders, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not hospitalized cancer patients under active treatment | |
| 2 | Caregivers of these cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning and quality of life
Measured: 5 to 8 times during 6 months
Secondary outcomes (1)
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
Measured: 5 to 8 times during 6 months for patients. Three times during 6 months for caregivers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Principal investigator, Tone Rustøen, Oslo University Hospital
- Investigators
- Tone Rustøen, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769301
- Sponsor's protocol ID
- 154-08158d
- Status last verified
- Jun 2011
- First submitted
- 8 Oct 2008
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing the Science of Symptom Management and Support for Cancer Patients and Their Caregivers
- ClinicalTrials.gov ID
- NCT00769301
- Acronym / sponsor ID
- 154-08158d
- Conditions
- Cancer, Pain, Fatigue, Depression, Sleeping Problems
- Keywords
- Symptoms, pain, fatigue, depression, sleeplessness, genetic markers, caregiver burden.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Nov 2008 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Not hospitalized cancer patients under active treatment |
| 2 | – | –Caregivers of these cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (7 listed)
- 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.
- above 18 years
Key exclusion criteria (1 listed)
- patients who had received radiation on the brain as this may affect their abilities to reliably complete questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical functioning and quality of life
Time frame: 5 to 8 times during 6 months
1 secondary outcome
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
Time frame: 5 to 8 times during 6 months for patients. Three times during 6 months for caregivers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tone Rustøen, PhD principal investigator
Oslo University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Pain, run by Oslo University Hospital at 3 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning and quality of life (time frame: 5 to 8 times during 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.