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

• 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 ]
  

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.

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