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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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)

Outcome Time Frame:

Until trial ends

Safety Issue:

No

Principal Investigator

Florian Strasser, MD, ABHPM

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital St. Gallen

Authority:

Switzerland: Ethical Committee

Study ID:

SAKK 95/06

NCT ID:

NCT00477919

Start Date:

February 2007

Completion Date:

January 2012

Related Keywords:

  • Cancer
  • 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
  • recurrent small cell lung cancer
  • recurrent bladder cancer
  • recurrent breast cancer
  • recurrent colon cancer
  • recurrent esophageal cancer
  • recurrent gastric cancer
  • recurrent melanoma
  • recurrent non-small cell lung cancer
  • recurrent ovarian epithelial cancer
  • recurrent ovarian germ cell tumor
  • stage IV pancreatic cancer
  • recurrent prostate cancer
  • recurrent renal cell cancer
  • recurrent pancreatic cancer
  • stage IV rectal cancer
  • recurrent rectal cancer
  • recurrent malignant mesothelioma
  • recurrent carcinoma of unknown primary
  • stage IV adult soft tissue sarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • recurrent extrahepatic bile duct cancer
  • unresectable gallbladder cancer
  • recurrent gallbladder cancer
  • adult glioblastoma

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