Trial Outcomes & Findings for Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials (NCT NCT02054715)
NCT ID: NCT02054715
Last Updated: 2021-01-27
Results Overview
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).
COMPLETED
NA
418 participants
Day 3 to 7
2021-01-27
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Baseline/Follow-up 1
STARTED
|
219
|
199
|
|
Baseline/Follow-up 1
COMPLETED
|
211
|
192
|
|
Baseline/Follow-up 1
NOT COMPLETED
|
8
|
7
|
|
Follow-up 2
STARTED
|
211
|
192
|
|
Follow-up 2
COMPLETED
|
192
|
173
|
|
Follow-up 2
NOT COMPLETED
|
19
|
19
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Baseline/Follow-up 1
Refused
|
1
|
3
|
|
Baseline/Follow-up 1
Medical
|
0
|
1
|
|
Baseline/Follow-up 1
Changed MD/Facility
|
0
|
1
|
|
Baseline/Follow-up 1
Disliked Procedure
|
0
|
1
|
|
Baseline/Follow-up 1
No Reason
|
0
|
1
|
|
Baseline/Follow-up 1
Overwhelmed
|
2
|
0
|
|
Baseline/Follow-up 1
Ineligible
|
3
|
0
|
|
Baseline/Follow-up 1
Hospitalization
|
1
|
0
|
|
Baseline/Follow-up 1
Changed Mind
|
1
|
0
|
|
Follow-up 2
Lost to Followup
|
3
|
1
|
|
Follow-up 2
Refused
|
3
|
2
|
|
Follow-up 2
Followup Not Completed
|
3
|
4
|
|
Follow-up 2
Ineligible
|
4
|
5
|
|
Follow-up 2
Death
|
3
|
3
|
|
Follow-up 2
Hospitalization
|
0
|
2
|
|
Follow-up 2
Changed MD/Facility
|
0
|
1
|
|
Follow-up 2
Changed Mind
|
0
|
1
|
|
Follow-up 2
No Reason
|
2
|
0
|
|
Follow-up 2
Treatment Change or Delay
|
1
|
0
|
Baseline Characteristics
Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
Baseline characteristics by cohort
| Measure |
Arm I (Print Educational)
n=219 Participants
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
|
Arm II (Multimedia Psychoeducational)
n=199 Participants
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
|
Total
n=418 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
61.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
214 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
195 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Marital Status
Never Married
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Marital Status
Currently Married
|
133 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
246 Participants
n=5 Participants
|
|
Marital Status
Separated
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Marital Status
Divorced
|
38 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Marital Status
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 3 to 7Population: 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).
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).
Outcome measures
| Measure |
Arm I (Print Educational)
n=211 Participants
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
|
Arm II (Multimedia Psychoeducational)
n=192 Participants
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
|
|---|---|---|
|
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
|
71.2 percentage of PDMS (0 - 100)
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Day 49-56Population: The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (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.
Outcome measures
| Measure |
Arm I (Print Educational)
n=192 Participants
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
|
Arm II (Multimedia Psychoeducational)
n=173 Participants
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
|
|---|---|---|
|
The Decision Regret Scale (DRS)
|
18.1 percentage of DRS (0 - 100)
Standard Error 1.1
|
18.3 percentage of DRS (0 - 100)
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Day 49-56Population: The population for this outcome is 192 (PE) + 173 (MP) = 365 This is defined as follow-up 2 (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.
Outcome measures
| Measure |
Arm I (Print Educational)
n=192 Participants
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
|
Arm II (Multimedia Psychoeducational)
n=173 Participants
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
|
|---|---|---|
|
The Decisional Conflict Scale (DCS)
|
18.0 Percentage of DCS (0 - 100)
Standard Error 0.9
|
17.9 Percentage of DCS (0 - 100)
Standard Error 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 49-56Population: 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).
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.
Outcome measures
| Measure |
Arm I (Print Educational)
n=192 Participants
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
|
Arm II (Multimedia Psychoeducational)
n=170 Participants
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
|
|---|---|---|
|
To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
Yes
|
119 Participants
|
117 Participants
|
|
To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
No
|
69 Participants
|
42 Participants
|
|
To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
Still Deciding
|
4 Participants
|
11 Participants
|
Adverse Events
Arm I (Print Educational)
Arm II (Multimedia Psychoeducational)
Serious adverse events
| Measure |
Arm I (Print Educational)
n=219 participants at risk
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
|
Arm II (Multimedia Psychoeducational)
n=199 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Hyponatremia, decreased WBC, post chemo
|
0.46%
1/219 • Number of events 1
|
0.00%
0/199
|
|
Hepatobiliary disorders
metastatic hepatocellular carcinoma
|
0.46%
1/219 • Number of events 1
|
0.00%
0/199
|
|
Gastrointestinal disorders
Perirectal abscess, large tumor with post obstructive atelectasis
|
0.46%
1/219 • Number of events 1
|
0.00%
0/199
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extensive metastatic melanoma (to skeletal system, liver, lungs, adrenal glands, mesentery, heart)
|
0.46%
1/219 • Number of events 1
|
0.00%
0/199
|
|
Hepatobiliary disorders
Metastatic melanoma to liver/ sepsis
|
0.00%
0/219
|
0.50%
1/199 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Stage IV lung cancer with widespread mets
|
0.00%
0/219
|
0.50%
1/199 • Number of events 1
|
|
General disorders
Death
|
0.00%
0/219
|
0.50%
1/199 • Number of events 1
|
Other adverse events
| Measure |
Arm I (Print Educational)
n=219 participants at risk
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
|
Arm II (Multimedia Psychoeducational)
n=199 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Fever post chemo
|
0.46%
1/219 • Number of events 1
|
0.00%
0/199
|
Additional Information
Gary R. Morrow, PhD, MS; Deans Professor of Oncology
University of Rochester Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive https://nctn-data-archive.nci.nih.gov/
- Publication restrictions are in place
Restriction type: OTHER