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OpenTrials
Completed

NCT Number: NCT00709813

Study to Test a Computer-assisted Support System to Improve Patient-centered Care and Symptom Relief in Cancer Patients

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.

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Key information

About this study

as above

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • having received radiation on the brain

Treatment and study plan

Tailored assessments provided to physicians and nurses (CHOICE, the Computer-assisted Interactive Tailored Patient Assessment Tool (ITPA))

Behavioral

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.

Primary outcomes

  1. Physicians' and nurses' symptom-related chart entries in patients' records

    Time frame: In-patient episodes of care

  2. Symptom distress over time

    Time frame: Repeated episodes of care

  3. Patients' prioritized needs for care over time

    Time frame: Repeated episodes of care

Secondary outcomes

  1. Patient satisfaction

    Time frame: End of study

  2. Care providers' satisfaction

    Time frame: End of study

  3. Preferences for participation in decision making- and changes over time

    Time frame: Baseline, and at completion of treatment

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

Including Patient Preferences in Symptom Management of Cancer Patients: A Randomized Clinical Trial

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jul 3, 2008
Registry last updated
Jul 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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