Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Facilitating Decision Making in Advanced Cancer Patients
RATIONALE: A computer-based survey and communication aid may help physicians and patients to
communicate better and help make treatment decisions easier.
PURPOSE: This phase III randomized clinical trial is studying how well giving a
computer-based survey together with a communication aid works compared to a computer-based
survey alone in improving physician-patient communication and treatment decision making in
patients with metastatic cancer.
OBJECTIVES:
- Compare satisfaction with physician-patient communication and decisional conflict in
patients with metastatic cancer undergoing a computer-based survey with vs without a
communication aid.
- Compare patient expectations regarding potential benefits and adverse reactions
associated with treatment options in patients undergoing the computer-based survey and
communication aid.
- Compare the content of physician-patient consultations in patients undergoing the
computer-based survey and communication aid.
OUTLINE: This is a randomized, controlled, multicenter study.
Patients are randomized to 1 of 3 study arms.
- Arm I (generic computer-based survey): Patients complete a 45- to 60-minute generic
computer-based survey that assesses demographics, familiarity and comfort with
computers, treatment history, and affective elements.
- Arm II (targeted computer-based survey and communication aid with physician summary
report): Patients complete a 45- to 60-minute targeted computer-based survey assessing
patient values, information needs, and distress. Patients then complete a targeted
computer-based communication aid that addresses cognitive and affective components of
cancer treatment education and provides communication skills training. After completion
of the survey and communication aid, a summary report of the survey results is
generated and provided to the patient's physician.
- Arm III (targeted computer-based survey and communication aid): Patients complete a
targeted computer-based survey and communication aid as in arm II. No summary report is
provided to the physician.
After completion of a computer-based survey and communication aid, all patients undergo a
consultation with their physician. A randomized subset of 25% of physician consultations*
are audiotaped and later analyzed. Patients complete a 15-minute written survey after
completion of the physician consultation and then at 3 months.
NOTE: *Patients are stratified according to study arm (I vs II vs III) and consulting
physician gender for this randomization.
PROJECTED ACCRUAL: A total of 720 patients will be accrued for this study.
;
Allocation: Randomized
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01828775 -
Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment
|
N/A | |
| Terminated |
NCT01642342 -
Recombinant Albumin Fusion Protein sEphB4-HSA in Treating Patients With Metastatic or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00002950 -
Topotecan Plus Sargramostim in Treating Patients With Advanced Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01705548 -
Hypofractionated Stereotactic Radiosurgery in Treating Patients With Large Brain Metastasis
|
N/A | |
| Completed |
NCT02146222 -
VEGFR/PDGFR Dual Kinase Inhibitor X-82 and Docetaxel in Treating Patients With Solid Tumors
|
Phase 1 | |
| Terminated |
NCT01602627 -
Hsp90 Inhibitor AUY922 in Treating Older Patients With Advanced Solid Malignancies
|
Phase 1 | |
| Completed |
NCT01191216 -
1-Methyl-D-Tryptophan and Docetaxel in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Recruiting |
NCT00992303 -
Collecting Tissue Samples From Patients With Cancer Undergoing Radiation Therapy and Healthy Participants
|
||
| Recruiting |
NCT01137825 -
Registry of Older Patients With Cancer
|
||
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00924651 -
Exercise in Lessening Fatigue Caused by Cancer in Patients Undergoing Chemotherapy
|
Phase 3 | |
| Withdrawn |
NCT00937417 -
S0716 Vandetanib and Docetaxel in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT00710632 -
Screening to Predict Weight Loss in Patients With Cancer
|
N/A | |
| Completed |
NCT00573690 -
Sorafenib Combined With Cisplatin and Etoposide or Carboplatin and Pemetrexed in Treating Patients With Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00544596 -
R-(-)-Gossypol Acetic Acid, Cisplatin, and Etoposide in Treating Patients With Advanced Solid Tumors or Extensive Stage Small Cell Lung Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT00436735 -
Nelfinavir in Treating Patients With Metastatic, Refractory, or Recurrent Solid Tumors
|
Phase 1 | |
| Completed |
NCT00352443 -
S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00126620 -
Sorafenib and Erlotinib in Treating Patients With Metastatic or Unresectable Solid Tumors
|
Phase 1 | |
| Completed |
NCT00128622 -
Denileukin Diftitox Followed by Vaccine Therapy in Treating Patients With Metastatic Cancer
|
Phase 1 |