CancerNCT00709813
Study to Test a Computer-assisted Support System to Improve Patient-centered Care and Symptom Relief in Cancer Patients
A study testing Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA)) in people with Cancer and Lymphoma, run by Oslo University Hospital.
Trial summary
Patient-provider shared decision making and the inclusion of patients' illness experiences and preferences in patient care are prioritized areas in health care. CHOICE is a computer-based support system for patient-centered symptom management of cancer patients developed for this purpose. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 2005
- Phase
- Interventional
- 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
Who may be able to join
- Starting treatment for a newly diagnosed acute myelogenous leukemia (AML), lymphatic leukemia (ALL), Hodgkin or non-Hodgkin lymphoma, or
- starting treatment for a recurrence of the disease;
- starting treatment with allogenous or autologous Stem Cell Transplantation (SCT).
- above 18 years of age.
Who cannot join
- having received radiation on the brain
About this study
Official title: Including Patient Preferences in Symptom Management of Cancer Patients: A Randomized Clinical Trial
Patient-provider shared decision making and the inclusion of patients' illness experiences and preferences in patient care are prioritized areas in health care. CHOICE is a computer-based support system for patient-centered symptom management of cancer patients developed for this purpose. In this randomized clinical trial at Rikshospitalet- Radiumhospitalet HF 145 adult stem-cell transplantation and newly diagnosed lymphoma and leukemia patients used CHOICE for assessments of their symptoms, problems and priorities for care at in-and outpatient visits during treatment and rehabilitation. In the experimental group this information was shared with physicians an nurses for subsequent care planning, but not in the control group.
This study tested effects of CHOICE on symptom- related patient care and outcomes of symptom relief, patients' needs for care over time and patient satisfaction;(2) analyzed how patients' symptoms, needs for care varied during illness/treatment stages; and (3) evaluated CHOICE' ease of use and user satisfaction. Controlling for gender, age, diagnosis, and type/stage of treatment, education, depression, health related quality of life, and social support, repeated measurement models were used to test differences and variations in outcome variables within and between groups and over time.
Read the detailed description
as above
- Conditions
- Cancer, Lymphoma, Leukemia, Stem Cell Transplantation
- Being tested
- Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))
- Keywords
- Symptom management, Cancer, Patient-centered care
- Medical subject headings
- Neoplasms, Lymphoma, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))Behavioural
Both groups used CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA)for symptom assessments at in- and outpatient visits during and up-to nine months after treatment. In the intervention group physicians and nurses had assessment summaries available for care planning, displaying patients' symptoms, problems and concerns in rank-order of their needs for care. In the control group assessments were not available to care providers at any time.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Not described Receives: Behavioral: Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physicians' and nurses' symptom-related chart entries in patients' records
Measured: In-patient episodes of care
Symptom distress over time
Measured: Repeated episodes of care
Patients' prioritized needs for care over time
Measured: Repeated episodes of care
Secondary outcomes (3)
Patient satisfaction
Measured: End of study
Care providers' satisfaction
Measured: End of study
Preferences for participation in decision making- and changes over time
Measured: Baseline, and at completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startDec 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Investigators
- Cornelia M Ruland, PhD, Principal investigator, Rikshospitalet-Radiumhospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709813
- Sponsor's protocol ID
- RCN 154739/320
- Status last verified
- Mar 2009
- First submitted
- 2 Jul 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruland CM. Clinicians' perceived usefulness of a support system for patient-centered cancer care. Stud Health Technol Inform. 2006;124:624-30.
PubMed 17108586Ruland CM, Bakken S, Roislien J. Reliability and validity issues related to interactive tailored patient assessments: a case study. J Med Internet Res. 2007 Aug 1;9(3):e22. doi: 10.2196/jmir.9.3.e22.
PubMed 17942384
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Including Patient Preferences in Symptom Management of Cancer Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00709813
- Acronym / sponsor ID
- RCN 154739/320
- Conditions
- Cancer, Lymphoma, Leukemia, Stem Cell Transplantation
- Keywords
- Symptom management, Cancer, Patient-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- Dec 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 3 Jul 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.
Patient-provider shared decision making and the inclusion of patients' illness experiences and preferences in patient care are prioritized areas in health care. CHOICE is a computer-based support system for patient-centered symptom management of cancer patients developed for this purpose. In this randomized clinical trial at Rikshospitalet- Radiumhospitalet HF 145 adult stem-cell transplantation and newly diagnosed lymphoma and leukemia patients used CHOICE for assessments of their symptoms, problems and priorities for care at in-and outpatient visits during treatment and rehabilitation. In the experimental group this information was shared with physicians an nurses for subsequent care planning, but not in the control group.
This study tested effects of CHOICE on symptom- related patient care and outcomes of symptom relief, patients' needs for care over time and patient satisfaction;(2) analyzed how patients' symptoms, needs for care varied during illness/treatment stages; and (3) evaluated CHOICE' ease of use and user satisfaction. Controlling for gender, age, diagnosis, and type/stage of treatment, education, depression, health related quality of life, and social support, repeated measurement models were used to test differences and variations in outcome variables within and between groups and over time.
Detailed description
as above
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Behavioral: Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA)) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Starting treatment for a newly diagnosed acute myelogenous leukemia (AML), lymphatic leukemia (ALL), Hodgkin or non-Hodgkin lymphoma, or
- starting treatment for a recurrence of the disease;
- starting treatment with allogenous or autologous Stem Cell Transplantation (SCT).
- above 18 years of age.
Key exclusion criteria (1 listed)
- having received radiation on the brain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))Both groups used CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA)for symptom assessments at in- and outpatient visits during and up-to nine months after treatment. In the intervention group physicians and nurses had assessment summaries available for care planning, displaying patients' symptoms, problems and concerns in rank-order of their needs for care. In the control group assessments were not available to care providers at any time. | Behavioural | 2 |
Primary outcome
Physicians' and nurses' symptom-related chart entries in patients' records
Time frame: In-patient episodes of care
Symptom distress over time
Time frame: Repeated episodes of care
Patients' prioritized needs for care over time
Time frame: Repeated episodes of care
3 secondary outcomes
Patient satisfaction
Time frame: End of study
Care providers' satisfaction
Time frame: End of study
Preferences for participation in decision making- and changes over time
Time frame: Baseline, and at completion of treatment
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 6 Jul 2011.
- Background: PubMed 17108586Ruland CM. Clinicians' perceived usefulness of a support system for patient-centered cancer care. Stud Health Technol Inform. 2006;124:624-30.
- Results publication: PubMed 17942384Ruland CM, Bakken S, Roislien J. Reliability and validity issues related to interactive tailored patient assessments: a case study. J Med Internet Res. 2007 Aug 1;9(3):e22. doi: 10.2196/jmir.9.3.e22.
Related trials for Cancer
Enrolling by invitation
Exercise Intervention for Breast Cancer Patients With Sarcopenia
Sarcopenia, Breast Cancer
RecruitingPhase 3
A Study Comparing TAK-928 With Docetaxel in Adults With Non-Small Cell Lung Cancer
IO Resistant Squamous and Nonsquamous NSCLC
Not yet recruitingPhase 2
Saruparib in HRDsig+ Solid Tumors
Malignant Neoplastic Disease (Disorder)
RecruitingPhase 2
IGFBP-2 Vaccine to Prevent Ovarian Cancer Progression in Patients With Serologic Detection of Recurrence
Fallopian Tube Carcinoma, Ovarian Carcinoma
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
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.
Cornelia M Ruland, PhD principal investigator
Rikshospitalet-Radiumhospitalet
Questions about this trial
What is this clinical trial studying?
A study testing Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA)) in people with Cancer and Lymphoma, run by Oslo University Hospital.
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 4 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 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Physicians' and nurses' symptom-related chart entries in patients' records (time frame: In-patient episodes of care). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00709813, which also lists 2 linked publications.
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 6 Jul 2011.