Electronic Tool to Record Cancer Symptoms in Patients With Advanced Cancer Receiving Palliative Care - Full Text View

Sponsor:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00477919

Purpose

RATIONALE: A hand held electronic tool used to monitor symptoms and assess quality of life may improve communication between patients and their doctors and improve the ability to plan treatment for patients with advanced cancer receiving palliative care. It is not yet known whether symptoms are better controlled with or without use of this electronic tool.

PURPOSE: This randomized phase III trial is studying an electronic tool to see how well it records cancer symptoms in patients with advanced cancer receiving palliative care.

Condition	Intervention	Phase
Cancer	Other: counseling intervention Procedure: cognitive assessment Procedure: fatigue assessment and management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment	Phase III

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Active Control
Official Title:	E-MOSAIC: A Multicenter Randomized Controlled Phase III Study of Longitudinal Electronic Monitoring of Symptoms and Syndromes Associated With Advanced Cancer in Patients Receiving Anticancer Treatment in Palliative Intention

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer breast cancer

MedlinePlus related topics: Cancer Lung Cancer Palliative Care Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Change in global quality of life (G-QOL) as measured at baseline and after study completion [ Designated as safety issue: No ]

Secondary Outcome Measures:

G-QOL after study completion [ Designated as safety issue: No ]
Communication as measured by patients' estimation of physicians' compassion and attribute and physicians' satisfaction with patient-physician communication [ Designated as safety issue: No ]
Change in symptoms and syndromes as measured by difference in Edmonton Symptom Assessment Scale Score, Karnofsky performance status, weight, shortness of breath, nutritional intake, and 3 patient chosen symptoms at baseline and after study completion [ Designated as safety issue: No ]
Symptom management performance as measured by number of visits with a symptom load above a defined threshold of 5 symptoms without immediate intervention and number of accompanying persons in weeks 3-6 [ Designated as safety issue: No ]
Factors influencing the change in G-QOL (i.e., tumor response [complete and partial response, stable or progressive disease], tumor type, predominant symptom, anxiety, complexity, education, hospitalization) [ Designated as safety issue: No ]
Change in burden of illness and treatment over time [ Designated as safety issue: No ]
Comparison of the number of mismatched decision-making preferences between weeks 3-6 [ Designated as safety issue: No ]

Estimated Enrollment:	192
Study Start Date:	February 2007
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the effect of an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC) and a Longitudinal Monitoring Sheet (LoMoS) on global quality of life (G-QOL) of patients with advanced incurable cancer receiving palliative anticancer treatment.

Secondary

Determine if this tool affects communication between these patients and their treating physicians.
Determine if this tool affects the symptoms and syndromes reported by these patients.
Determine if this tool impacts symptom management performance.

Tertiary

Identify factors influencing changes in G-QOL.
Determine how patients adapt to illness and burden of treatment.
Describe patients' decision-making preference.

OUTLINE: This is a controlled, randomized, longitudinal, multicenter study. Physicians are stratified according to participating center. Physicians are randomized to 1 of 2 arms. All patients allocated to a physician undergo the same intervention.

Arm I: Patients complete a weekly symptom assessment and nutritional intake using a Palm-based monitoring tool. Nurses record weight and Karnofsky performance status (KPS) scores weekly. A proof of electronic transfer sheet is printed and stored.
Arm II: Patients complete a weekly assessment comprising visual analogue scales (VAS) of pain, fatigue, drowsiness, nausea, anxiety, depression, shortness of breath, loss of appetite, and overall well-being; up to 3 optional symptoms selected by the patient; and an estimated nutritional intake using an electronic tool for monitoring symptoms and syndromes associated with advanced cancer (E-MOSAIC). Nurses record the patient's weight, KPS score, body mass index, and assessment of current medication for pain (i.e., morphine-equivalent daily dose), fatigue, and anorexia/cachexia syndromes weekly. A Longitudinal Monitoring Sheet (LoMoS) is printed (comprising VAS of pain, pain medication, fatigue, KPS, medication for fatigue [i.e., methylphenidate hydrochloride or epoetin alfa], anorexia, weight change, nutritional intake, medication, supplements, counseling for anorexia, VAS of individually selected symptoms) and stored.

In both arms, patients are assessed for outcome criteria at baseline and at weeks 3 and 6 (end of study).

PROJECTED ACCRUAL: A total of 24 physicians and 192 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of advanced incurable cancer
Symptomatic disease, defined as meeting ≥ 1 of the following criteria:
- Pain Visual Analogue Scale (VAS) ≥ 3/10 and/or morphine equivalent daily dose of ≥ 10 mg for ≥ 3 days
- Anorexia VAS ≥ 3/10 and/or weight loss of ≥ 2% in 2 months or ≥ 5% in 6 months
- Fatigue VAS ≥ 3/10 and/or Karnofsky performance status < 70%
- Depression or anxiety VAS ≥ 3/10 and/or treatment with antidepressants for ≥ 5 days and planned for ≥ 1 month
Receiving continuously, weekly, or biweekly palliative anticancer treatment meeting 1 of the following criteria:
- At least 1 first-line treatment for any of the following:
  - Metastatic melanoma
  - Renal cell cancer
  - Pancreatic cancer
  - Biliary tract cancer
  - Mesothelioma
  - Prostate cancer (chemotherapy)
  - Advanced glioblastoma
- At least 1 second-line treatment for any of the following:
  - Extensive stage small cell lung cancer
  - Stage IV non-small cell lung cancer
  - Colorectal cancer
  - Gastric cancer
  - Esophageal cancer
  - Bladder cancer
  - Sarcoma
  - Carcinoma of unknown primary
- At least 1 third-line chemotherapy regimen for any of the following:
  - Metastatic breast cancer
  - Ovarian cancer
Anticancer treatment must be given in an outpatient setting, not within a clinical trial, with weekly monitoring, and expected tumor response rate ≤ 20% according to the literature
No testicular cancer
No hematological malignancies
No primary brain tumors other than glioblastoma
Physician characteristics:
- No change to standard of care for symptom assessment or to major communication skills strategies within the past 3 months
- Experienced in medical oncology (i.e., worked ≥ 50% in clinical oncology within the past 24 months)
- Likely to stay in the participating institution for the time required to treat ≥ 5 study patients
- Able to independently communicate with the patient about all aspects of cancer care
- Able to independently perform immediate changes of interventions in patient care without the institutional requirement to counsel another colleague before prescribing (i.e., for symptom control)
- Completed a basic communication skills course or equivalent training (i.e., familiar with communication skills)

PATIENT CHARACTERISTICS:

Able to understand assessment instrument language
Able to understand physician communication without difficulty (i.e., due to culture, language, speech)

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No concurrent participation in another clinical trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477919

Locations

Switzerland
Inselspital Bern	Recruiting
Bern, Switzerland, CH-3010
Contact: Contact Person 41-31-632-2111
Kantonsspital - St. Gallen	Recruiting
St. Gallen, Switzerland, CH-9007
Contact: Florian Strasser, MD, ABHPM 41-71-494-1111 florian.strasser@kssg.ch
Kantonsspital Freiburg	Recruiting
Freiburg, Switzerland, 1708
Contact: Contact Person 41-26-426-7243
Universitaetsspital-Basel	Recruiting
Basel, Switzerland, CH-4031
Contact: Contact Person 41-61-265-5075
Oncology Institute of Southern Switzerland	Recruiting
Bellinzona, Switzerland, CH-6500
Contact: Contact Person 41-91-811-9039
Spital Buelach	Recruiting
Bulach, Switzerland, CH-8180
Contact: Contact Person 41-44-862-7300
Kantonsspital Graubuenden	Recruiting
Chur, Switzerland, CH-7000
Contact: Contact Person 41-81-256-6111

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:

Florian Strasser, MD, ABHPM

Kantonsspital - St. Gallen

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000536483, SWS-SAKK-95/06, EU-20711, SWS-SAKK-E-MOSAIC
Study First Received:	May 23, 2007
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00477919 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
stage IV renal cell cancer
unresectable extrahepatic bile duct cancer
advanced malignant mesothelioma
stage IV prostate cancer
adult giant cell glioblastoma
adult gliosarcoma
extensive stage small cell lung cancer
stage IV non-small cell lung cancer
stage IV colon cancer
stage IV gastric cancer
stage IV esophageal cancer
stage IV bladder cancer
male breast cancer
stage IV breast cancer

stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
ovarian sarcoma
ovarian stromal cancer
fatigue
anorexia
cachexia
pain
weight changes
depression
poor performance status
recurrent adult brain tumor
clear cell sarcoma of the kidney
advanced adult primary liver cancer
recurrent adult primary liver cancer

ClinicalTrials.gov processed this record on November 27, 2009