Malignant Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALprint educational intervention
print educational intervention
multimedia psychoeducational intervention
Sponsors
National Cancer Institute (NCI)
Gary Morrow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be able to speak and read English * Be diagnosed with cancer * Have been informed of their eligibility for a specific phase II or III therapeutic clinical trial open for enrollment at the participating NCI Community Oncology Research Program (NCORP) site * Have already met one or more eligibility criteria and have a reasonable expectation of meeting any remaining eligibility criteria for the therapeutic clinical trial * Be capable of providing written informed consent for study participation
Exclusion criteria
* Participants must not have been asked previously to participate in another therapeutic cancer clinical trial * Participants must not have already made a decision to participate in the phase II or III therapeutic clinical trial for which they were informed of their eligibility * Participants must not have documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation (e.g., blindness, deafness, psychosis, or dementia) * Participants must not be eligible only for phase I trial; these patients are excluded because few of these trials are offered at NCORP sites and because their design and goals differ considerably from those of phase II and III trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale | Day 3 to 7 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Decision Regret Scale (DRS) | Day 49-56 | 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 Decisional Conflict Scale (DCS) | Day 49-56 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | Day 49-56 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 219 |
| 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 | 199 |
| Total | 418 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Baseline/Follow-up 1 | Changed MD/Facility | 0 | 1 |
| Baseline/Follow-up 1 | Changed Mind | 1 | 0 |
| Baseline/Follow-up 1 | Disliked Procedure | 0 | 1 |
| Baseline/Follow-up 1 | Hospitalization | 1 | 0 |
| Baseline/Follow-up 1 | Ineligible | 3 | 0 |
| Baseline/Follow-up 1 | Medical | 0 | 1 |
| Baseline/Follow-up 1 | No Reason | 0 | 1 |
| Baseline/Follow-up 1 | Overwhelmed | 2 | 0 |
| Baseline/Follow-up 1 | Refused | 1 | 3 |
| Follow-up 2 | Changed MD/Facility | 0 | 1 |
| Follow-up 2 | Changed Mind | 0 | 1 |
| Follow-up 2 | Death | 3 | 3 |
| Follow-up 2 | Followup Not Completed | 3 | 4 |
| Follow-up 2 | Hospitalization | 0 | 2 |
| Follow-up 2 | Ineligible | 4 | 5 |
| Follow-up 2 | Lost to Followup | 3 | 1 |
| Follow-up 2 | No Reason | 2 | 0 |
| Follow-up 2 | Refused | 3 | 2 |
| Follow-up 2 | Treatment Change or Delay | 1 | 0 |
Baseline characteristics
| Characteristic | Arm I (Print Educational) | Arm II (Multimedia Psychoeducational) | Total |
|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 11.2 | 61.5 years STANDARD_DEVIATION 12.6 | 61.5 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 214 Participants | 192 Participants | 406 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Marital Status Currently Married | 133 Participants | 113 Participants | 246 Participants |
| Marital Status Divorced | 38 Participants | 34 Participants | 72 Participants |
| Marital Status Never Married | 19 Participants | 20 Participants | 39 Participants |
| Marital Status Separated | 9 Participants | 4 Participants | 13 Participants |
| Marital Status Unknown | 2 Participants | 0 Participants | 2 Participants |
| Marital Status Widowed | 18 Participants | 28 Participants | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 19 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 195 Participants | 177 Participants | 372 Participants |
| Sex: Female, Male Female | 134 Participants | 121 Participants | 255 Participants |
| Sex: Female, Male Male | 85 Participants | 78 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 219 | 3 / 199 |
| other Total, other adverse events | 1 / 219 | 0 / 199 |
| serious Total, serious adverse events | 4 / 219 | 3 / 199 |
Outcome results
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).
Time frame: Day 3 to 7
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Print Educational) | Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale | 71.3 percentage of PDMS (0 - 100) | Standard Error 1.4 |
| Arm II (Multimedia Psychoeducational) | Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale | 71.2 percentage of PDMS (0 - 100) | Standard Error 1.5 |
Comparison: Two-sided F-Test as a statistical comparing MP and PE means.p-value: 0.962195% CI: [-4.1, 3.9]F-Test
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.
Time frame: Day 49-56
Population: The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Print Educational) | The Decisional Conflict Scale (DCS) | 18.0 Percentage of DCS (0 - 100) | Standard Error 0.9 |
| Arm II (Multimedia Psychoeducational) | The Decisional Conflict Scale (DCS) | 17.9 Percentage of DCS (0 - 100) | Standard Error 1.1 |
Comparison: Two-sided F-Test comparing the MP and PE means.p-value: 0.970995% CI: [-2.79, 2.69]F-Test
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.
Time frame: Day 49-56
Population: The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (Day 49-56).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Print Educational) | The Decision Regret Scale (DRS) | 18.1 percentage of DRS (0 - 100) | Standard Error 1.1 |
| Arm II (Multimedia Psychoeducational) | The Decision Regret Scale (DRS) | 18.3 percentage of DRS (0 - 100) | Standard Error 1.1 |
Comparison: Two-sided F-Test comparing the MP and PE means.p-value: 0.906595% CI: [-2.89, 3.26]F-test
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.
Time frame: Day 49-56
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (Print Educational) | To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | Yes | 119 Participants |
| Arm I (Print Educational) | To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | No | 69 Participants |
| Arm I (Print Educational) | To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | Still Deciding | 4 Participants |
| Arm II (Multimedia Psychoeducational) | To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | Yes | 117 Participants |
| Arm II (Multimedia Psychoeducational) | To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | No | 42 Participants |
| Arm II (Multimedia Psychoeducational) | To Explore the Effects of Intervention Assignment on Clinical Trial Participation. | Still Deciding | 11 Participants |
Comparison: Chi-square test between MP and PE. 69% of subjects that got the Multimedia Psychoeducation intervention chose to participate in a clinical trial, compared with 62% in the Print Education groupp-value: 0.014Chi-squared