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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02237 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC12107 | Other Identifier | University of Rochester | |
| URCC-12107 | Other Identifier | DCP | |
| U10CA037420 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized clinical trial compares multimedia psychoeducation to print education in preparing patients with cancer for decision making about clinical trial participation. Multimedia psychoeducation includes a digital video disc (DVD) and written materials with a combined focus on knowledge and attitude change, and may be an effective method to help patients prepare for decision making about clinical trial participation. It is not yet known whether a multimedia psychoeducation is more effective than print education in preparing patients for decision making about clinical trials.
PRIMARY OBJECTIVES:
I. To determine the effect of intervention assignment on patients' preparedness for decision making about clinical trial participation.
SECONDARY OBJECTIVES:
I. To determine the effect of intervention assignment on indicators of the quality of patients' decision making about clinical trial participation.
II. To examine mechanisms by which multimedia psychoeducation (MP) exerts its expected positive effects on preparedness for decision making.
TERTIARY OBJECTIVES:
I. To explore the effects of intervention assignment on clinical trial participation.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the National Cancer Institute (NCI) booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
ARM II: Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a digital video disk (DVD) and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
After completion of study, patients are followed up at 3-7 and 49-56 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (print educational) | Experimental | Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials. |
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| Arm II (multimedia psychoeducational) | Experimental | Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| print educational intervention | Behavioral | print educational intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale | Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision. Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal. Larger number is better. All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared). | Day 3 to 7 |
| Measure | Description | Time Frame |
|---|---|---|
| The Decision Regret Scale (DRS) | The Decision Regret Scale (DRS) is a five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). A mean score for the DRS is calculated by reverse scoring the two negatively phrased items and dividing by five. The mean scores are converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25 and higher scores represent increases in the severity of decision regret. Higher scores are worse. |
| Measure | Description | Time Frame |
|---|---|---|
| To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | Given the ethical perspective that patients have a right to make autonomous decisions about clinical trial participation, no hypothesis is offered about the effect of intervention assignment on clinical trial participation rates. To conduct the exploratory analysis regarding the effects of intervention assignment on clinical trial participation, data for all patients offered participation in a therapeutic clinical trial will be entered into a 2 (Intervention: MP or PE) x 2 (Clinical Trial Participation: Yes or No/Still Deciding) contingency table and analyzed using either a Fisher exact test or chi-square test as appropriate. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Jacobsen | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego State University | San Diego | California | 92182 | United States | ||
| H. Lee Moffitt Cancer Center and Research Institute |
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| Label | URL |
|---|---|
| Description: Clinical trial summary from the National Cancer Institute's PDQ® database | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Print Educational) | Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials. print educational intervention: print educational intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Baseline/Follow-up 1 |
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| multimedia psychoeducational intervention | Behavioral | multimedia psychoeducational intervention |
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| Day 49-56 |
| The Decisional Conflict Scale (DCS) | The Decisional Conflict Scale (DCS) is a valid and reliable 16-item self-report measure that assesses the extent to which respondents experience certainty, satisfaction, and confidence following a health care decision. In the present study, it will be keyed to the decision about therapeutic clinical trial participation. Instructions given to respondents include asking them to reflect on the decisions have just made or are about to make and to respond to statements in the DCS using a five-point Likert scale. Responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. | Day 49-56 |
| Day 49-56 |
| Tampa |
| Florida |
| 33612 |
| United States |
| Hawaii MU-NCORP | Honolulu | Hawaii | 96813 | United States |
| Heartland NCORP | Decatur | Illinois | 62526 | United States |
| Kansas City Clinical Oncology Program | Prairie Village | Kansas | 66208 | United States |
| Gulf South MU-NCORP | New Orleans | Louisiana | 70112 | United States |
| Cancer Research Consortium of West Michigan | Grand Rapids | Michigan | 49503 | United States |
| Metro MN NCORP | Minneapolis | Minnesota | 55426 | United States |
| Nevada Cancer Research Foundation NCORP | Las Vegas | Nevada | 89106 | United States |
| Nevada NCORP | Las Vegas | Nevada | 89106 | United States |
| URCC / University of Rochester NCORP Research Base | Rochester | New York | 14642 | United States |
| Southeast Clinical Oncology Research Consortium | Winston-Salem | North Carolina | 27104 | United States |
| Columbus NCORP | Columbus | Ohio | 43215 | United States |
| Dayton Community Oncology Program | Dayton | Ohio | 45420 | United States |
| Geisinger Cancer Institute NCORP | Danville | Pennsylvania | 17822 | United States |
| Greenville Health System Cancer Instutite/Greenville NCORP | Greenville | South Carolina | 29615 | United States |
| Wisconsin NCORP | Marshfield | Wisconsin | 54449 | United States |
| Aurora NCORP | Milwaukee | Wisconsin | 53226 | United States |
| FG001 | Arm II (Multimedia Psychoeducational) | Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home. multimedia psychoeducational intervention: multimedia psychoeducational intervention |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Print Educational) | Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials. print educational intervention: print educational intervention |
| BG001 | Arm II (Multimedia Psychoeducational) | Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home. multimedia psychoeducational intervention: multimedia psychoeducational intervention |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale | Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision. Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal. Larger number is better. All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared). | There were 219 (PE) + 199 (MP) = 418 at Baseline. The population for this outcome is 211 (PE) + 192 (MP) = 403 This is defined as follow-up 1 (Day 3-7). | Posted | Mean | Standard Error | percentage of PDMS (0 - 100) | Day 3 to 7 |
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| Secondary | The Decision Regret Scale (DRS) | The Decision Regret Scale (DRS) is a five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). A mean score for the DRS is calculated by reverse scoring the two negatively phrased items and dividing by five. The mean scores are converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25 and higher scores represent increases in the severity of decision regret. Higher scores are worse. | The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56). | Posted | Mean | Standard Error | percentage of DRS (0 - 100) | Day 49-56 |
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| Secondary | The Decisional Conflict Scale (DCS) | The Decisional Conflict Scale (DCS) is a valid and reliable 16-item self-report measure that assesses the extent to which respondents experience certainty, satisfaction, and confidence following a health care decision. In the present study, it will be keyed to the decision about therapeutic clinical trial participation. Instructions given to respondents include asking them to reflect on the decisions have just made or are about to make and to respond to statements in the DCS using a five-point Likert scale. Responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict. | The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56). | Posted | Mean | Standard Error | Percentage of DCS (0 - 100) | Day 49-56 |
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| Other Pre-specified | To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | Given the ethical perspective that patients have a right to make autonomous decisions about clinical trial participation, no hypothesis is offered about the effect of intervention assignment on clinical trial participation rates. To conduct the exploratory analysis regarding the effects of intervention assignment on clinical trial participation, data for all patients offered participation in a therapeutic clinical trial will be entered into a 2 (Intervention: MP or PE) x 2 (Clinical Trial Participation: Yes or No/Still Deciding) contingency table and analyzed using either a Fisher exact test or chi-square test as appropriate. | The population for this outcome is 192 (PE) + 170 (MP) = 362 Note: There were 3 individuals (MP) who did not answer this question. This is defined as follow-up 2 (Day 49-56). | Posted | Count of Participants | Participants | Day 49-56 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Print Educational) | Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials. print educational intervention: print educational intervention | 3 | 219 | 4 | 219 | 1 | 219 |
| EG001 | Arm II (Multimedia Psychoeducational) | Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home. multimedia psychoeducational intervention: multimedia psychoeducational intervention | 3 | 199 | 3 | 199 | 0 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatremia, decreased WBC, post chemo | Blood and lymphatic system disorders | Systematic Assessment |
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| metastatic hepatocellular carcinoma | Hepatobiliary disorders | Systematic Assessment | Death |
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| Perirectal abscess, large tumor with post obstructive atelectasis | Gastrointestinal disorders | Systematic Assessment | Death |
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| Extensive metastatic melanoma (to skeletal system, liver, lungs, adrenal glands, mesentery, heart) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Death |
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| Metastatic melanoma to liver/ sepsis | Hepatobiliary disorders | Systematic Assessment | Death |
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| Stage IV lung cancer with widespread mets | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Death |
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| Death | General disorders | Systematic Assessment | Death |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever post chemo | Infections and infestations | Systematic Assessment |
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Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary R. Morrow, PhD, MS; Deans Professor of Oncology | University of Rochester Medical Center | 585-275-9961 | Gary_Morrow@urmc.rochester.edu |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Followup Not Completed |
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| Ineligible |
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| Death |
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| Hospitalization |
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| Changed MD/Facility |
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| Changed Mind |
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| No Reason |
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| Treatment Change or Delay |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Currently Married |
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| Separated |
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| Divorced |
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| Widowed |
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| Unknown |
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