Personalized Information or Basic Information in Helping Patients Make Decisions About Participating in a Clinical Trial

Lymphoma Clinical Trial

Official title:

Preparatory Aid to Improve Decision Making About Cancer Clinical Trials (PRE-ACT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750009
• Other study ID #: CASE18Z09
• Secondary ID: R01CA127655FCCC-
• Status: Completed
• Phase: Phase 3
• Start date: April 2008
• Est. completion date: December 2012

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Providing information that is tailored to answer patients' questions about clinical trials may help patients with cancer decide to enroll in a clinical trial. It is not known whether providing personalized information is more effective than basic information in helping patients make decisions about clinical trials.

PURPOSE: This randomized phase III trial is studying personalized information to see how well it works compared with basic information in helping patients make decisions about participating in a clinical trial.

Description:

OBJECTIVES:

Primary

• To improve preparation for consideration of clinical trials by providing tailored information to address barriers related to knowledge, goals and values, and beliefs and expectancies before their physician visit in patients with advanced metastatic or early stage cancer.

Secondary

• To develop and pilot test a tailored interactive preparatory aid (PRE-ACT) to promote informed cancer treatment decision making by addressing barriers to considering clinical trials as a treatment option.

• To evaluate the efficacy of PRE-ACT in improving preparation for considering participation in clinical trials by conducting a randomized clinical trial to compare PRE-ACT vs generic clinical trial information with text (control condition).

• To investigate relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes.

• To investigate the impact of PRE-ACT on patient decisional conflict, satisfaction with information received, satisfaction with discussion about clinical trials with the physician, satisfaction with the treatment decision, clinical trials discussion, clinical trials participation, and quality of informed consent.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I (PRE-ACT): Patients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.

• Arm II (control): Patients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.

All patients complete a baseline assessment to assess demographics, personal characteristics, preparedness, and barriers to clinical trials. All patients also undergo a post-intervention assessment and complete a survey to measure preparedness for consideration of clinical trials, and impact of the intervention on clinical trials barriers. A brief patient post-consultation assessment is completed by patients within two weeks of the physician consultation to determine whether clinical trials were discussed, patient satisfaction with discussion about clinical trials, treatment options, treatment selection, decisional conflict, and satisfaction with treatment decision. Quality of informed consent is also assessed for patients participating in a clinical trial and completing the consent process during their initial physician consultation. Each patient's physician completes a brief Physician Post-Consultation Assessment to define cancer stage, treatment goal, and to determine whether clinical trials were offered and accepted and if not, why not. For patients who have not made a treatment decision after consultation, a brief follow-up phone survey or medical chart review is used to identify the patient's treatment choice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

• Advanced (metastatic) disease

• Early stage (i.e., appropriate for adjuvant therapy) disease

• Scheduled for first outpatient consultation with a medical oncologist at the Clinical Centers

PATIENT CHARACTERISTICS:

• Able to read and verbally communicate in English

• Patients who choose to complete the intervention at home rather than at the Clinical Center before their visit must have high-speed (i.e., DSL or cable) Internet access

PRIOR CONCURRENT THERAPY:

• Not specified

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Chronic Myeloproliferative Disorders
• Disease
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Nervous System Neoplasms
• Preleukemia
• Syndrome
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Other:
• educational intervention
Patients receive a tailored intervention or generic information

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in preparation for consideration of clinical trials		after pts.complete all survey measures
Secondary	Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT)		after pts.complete all survey measures
Secondary	Efficacy of PRE-ACT		after pts.complete all survey measures
Secondary	Comparison of PRE-ACT and genomic clinical trial information with text		after pts.complete all survey measures
Secondary	Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes		after pts.complete all survey measures
Secondary	Impact of PRE-ACT on patient	To investigate the impact of PRE-ACT on patient decisional conflict, satisfaction with information received, satisfaction with discussion about clinical trials with the physician, satisfaction with the treatment decision, clinical trials discussion, clinical trials participation, and quality of informed consent. (Exploratory Aim)	after pts.complete all survey measures