Computerized Questionnaires in Assessing Symptoms, Pain, Depression, and Physical Function in Patients With Metastatic and/or Advanced Locoregional Cancer

Norwegian University of Science and Technology

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Cachexia; Depression; Pain

Treatments: Other: questionnaire administration; Procedure: assessment of therapy complications; Procedure: quality-of-life assessment; Other: computer-assisted intervention

Study type: Observational

Funder types: Other

Identifiers

NCT00972634

EU-20962

CDR0000648077

NUST-EPCRC-CSA

Details and patient eligibility

About

RATIONALE: A computer-based system for assessing symptoms may be effective for patients with metastatic or advanced cancer.

PURPOSE: This clinical trial is studying how well computerized questionnaires work in assessing symptoms, pain, depression, and physical function in patients with metastatic and/or advanced local/regional cancer.

Full description

OBJECTIVES:

• Determine the feasibility of applying a computer-based system for symptom assessment and classification in palliative cancer care in patients with metastatic and/or advanced cancer.
• Examine hypothesized differences across groups related to acceptance of computers (i.e., age, culture, stage of disease, cognitive and physical function, etc.).
• Examine the general user-friendliness of the tool.
• Test and validate the performance of selected domains and items for classification and assessment of pain and cachexia.
• Explore the validity of domains and items for depression.

OUTLINE: This is a multicenter study.

All patients undergo computer-based assessments of general symptoms by the Edmonton Symptom Assessment System (ESAS) and the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ C30) questionnaires and assessment of physical function, appetite/weight loss, and depression by the Brief Patient Health Questionnaire 9 (PRIME-MD PHQ9). Patients who score ≥ 1 (on a 0-10 numerical rating score) on the pain screening question with or without occurrence of breakthrough pain (BTP), undergo the Alberta BTP Assessment tool assessing precipitating factors for pain, time to pain relief after intake of medication, and satisfaction with medication. Patients complete questions regarding user-friendliness and feasibility of using the computer at the end of their session.

Enrollment: 1,051 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of incurable cancer, including patients receiving life-prolonging treatment
• Metastatic and/or advanced locoregional disease

PATIENT CHARACTERISTICS:

• Able to provide written informed consent
• Fluent in the language used at the study site

PRIOR CONCURRENT THERAPY:

• No prior inclusion in this study