Clinical Trial Finder

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

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.

Arms

: Weekly assessment by E-MOSAIC

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.

: Palm-based monitoring tool

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.

Interventions