Brief Summary

This pilot clinical trial studies how well using the internet to collect symptoms and the ability to carry out daily activities works in patients with enrolled on Cancer and Leukemia Group B (CALGB) studies. A study that evaluates a patient's ability to use a clinic waiting room computer to report their symptoms and their ability to carry out daily activities may help doctors understand a patient's use of a computer to report symptoms.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

325

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline

Completed

Started Dec 2006

Longer than P75 for not_applicable prostate-cancer

Geographic Reach

1 country

95 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.5 years study duration

Study Start

First participant enrolled

December 1, 2006

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 28, 2006

Completed

6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed

4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed

Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

6.3 years

First QC Date

December 27, 2006

Last Update Submit

June 26, 2017

Conditions

Prostate Cancer Breast Cancer Lung Cancer Colorectal Cancer Leukemia Multiple Myeloma

Keywords

adenocarcinoma of the prostaterecurrent prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (3)

Willingness of approached patients to participate in this study this study
Up to 6 years
Proportion of enrolled patients who submit an online questionnaire at any given follow-up visit any given follow-up visit
Up to 16 weeks
Proportion of total attended visits during the study period at which a questionnaire was completed (completers:visits) which a questionnaire was completed (completers:visits)
Up to 15 weeks

Secondary Outcomes (3)

Patient-reported CTCAE symptoms using symptom severity data
At baseline (day 22)
Clinician-reported CTCAE symptoms using symptom severity data clinician reporting at day 43 (when patients report before clinicians; clinicians view those reports) vs at day 22 (patients report symptoms after the clinical encounter)
At baseline (day 22)
Mean severity scores for patient reporting at day 43
Up to day 43

Study Arms (1)

(Internet-based STAR database)

OTHER

Patients are registered into the STAR database, obtain a password, undergo STAR training, and complete a patient-STAR questionnaire after seeing their clinician (baseline self-report) on day 1 of course 2\* of chemotherapy. Patients are reminded to complete online STAR questionnaire before seeing their clinician on day 1 of courses 3, 4, 5, and 6\* of chemotherapy. Clinicians review these patient reports before creating their own assessment. Patients also complete a patient feedback survey on day 1 of course 4\* of chemotherapy. Clinicians complete feedback survey at study completion. NOTE: \*All time points are based on scheduled therapy with clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-70604, CALGB-80405, or CALGB-40503.

Other: internet-based interventionOther: assessment of therapy complicationsOther: Questionnaire Administration

Interventions

internet-based interventionOTHER

Use the STAR database system

(Internet-based STAR database)

assessment of therapy complicationsOTHER

Use the STAR database system

(Internet-based STAR database)

Questionnaire AdministrationOTHER

Ancillary studies

(Internet-based STAR database)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Enrolled on clinical trial CALGB-90401, CALGB-30607, CALGB-30704, CALGB-40601, CALGB-40603, CALGB-40502, CALGB-40503, CALGB-70604, or CALGB-80405 PATIENT CHARACTERISTICS: * Able to read and comprehend English language text * Able to see a computer screen (i.e., no visual impairments) or be accompanied at visits by someone who can read the screen for the patient PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (95)

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus