AzTrials
AzTrials

Brain and Central Nervous System TumorsPhase 3NCT00750009

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

A Phase 3 study testing educational intervention in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Case Comprehensive Cancer Center at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
583 participants
Where
4 sitesUnited States
Study dates
Apr 2008to Dec 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
educational intervention
Keywords
unspecified adult solid tumor, protocol specific, accelerated phase chronic myelogenous leukemia, acute undifferentiated leukemia, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), atypical chronic myeloid leukemia, BCR-ABL1 negative, blastic phase chronic myelogenous leukemia, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood chronic myelogenous leukemia, chronic myelomonocytic leukemia, chronic phase chronic myelogenous leukemia, juvenile myelomonocytic leukemia, mast cell leukemia, meningeal chronic myelogenous leukemia
Medical subject headings
Central Nervous System Neoplasms, Myeloproliferative Disorders, Leukemia, Lymphoma, Lymphoproliferative Disorders, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • educational interventionOther

    Patients receive a tailored intervention or generic information

Study groups in NCT00750009
Study groupRoleWhat they receive
Arm I (PRE-ACT)ExperimentalPatients receive tailored feedback and video content to address clinical trial barriers following baseline assessment.
Receives: Other: educational intervention
Arm II (control)Active comparatorPatients receive generic clinical trials educational feedback taken from NCI publications following baseline assessment.
Receives: Other: educational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvement in preparation for consideration of clinical trials

    Measured: after pts.complete all survey measures

Secondary outcomes (5)

  1. Development and pilot testing of a tailored interactive preparatory aid (PRE-ACT)

    Measured: after pts.complete all survey measures

  2. Efficacy of PRE-ACT

    Measured: after pts.complete all survey measures

  3. Comparison of PRE-ACT and genomic clinical trial information with text

    Measured: after pts.complete all survey measures

  4. Relevant background and psychosocial variables that are associated with preparedness, barriers, and treatment outcomes

    Measured: after pts.complete all survey measures

  5. 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)

    Measured: after pts.complete all survey measures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
583 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00750009
Sponsor's protocol ID
CASE18Z09
Other IDs
R01CA127655, FCCC-08808
Status last verified
Jul 2020
First submitted
9 Sep 2008
Last updated
27 Jul 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Meropol NJ, Wong YN, Albrecht T, Manne S, Miller SM, Flamm AL, Benson AB 3rd, Buzaglo J, Collins M, Egleston B, Fleisher L, Katz M, Kinzy TG, Liu TM, Margevicius S, Miller DM, Poole D, Roach N, Ross E, Schluchter MD. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials. J Clin Oncol. 2016 Feb 10;34(5):469-78. doi: 10.1200/JCO.2015.63.2257. Epub 2015 Dec 23.

    PubMed 26700123

  • Wong YN, Schluchter MD, Albrecht TL, Benson AB 3rd, Buzaglo J, Collins M, Flamm AL, Fleisher L, Katz M, Kinzy TG, Liu TM, Manne S, Margevicius S, Miller DM, Miller SM, Poole D, Raivitch S, Roach N, Ross E, Meropol NJ. Financial Concerns About Participation in Clinical Trials Among Patients With Cancer. J Clin Oncol. 2016 Feb 10;34(5):479-87. doi: 10.1200/JCO.2015.63.2463. Epub 2015 Dec 23.

    PubMed 26700120

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing educational intervention in people with Brain and Central Nervous System Tumors and Chronic Myeloproliferative Disorders, run by Case Comprehensive Cancer Center at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in preparation for consideration of clinical trials (time frame: after pts.complete all survey measures). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00750009, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.

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