Trial Outcomes & Findings for Myeloproliferative Neoplasms: an In-depth Case-control Study (NCT NCT01831635)
NCT ID: NCT01831635
Last Updated: 2024-01-08
Results Overview
* Difference in participation rates in those receiving: * vs. not receiving a pen at initial contact. * vs. not receiving a trolley token at initial contact. * vs. not receiving a monetary incentive at initial contact. * a MOSAICC pen vs. a non-branded pen following second contact. * vs. not receiving a trolley token following second contact. * a MOSAICC branded Pen +/or trolley token alone vs no non-monetary incentive following a second invite. * a MOSAICC branded Pen +/or trolley token alone vs no incentive following a second invite. * a MOSAICC branded Pen +/or trolley token alone vs pen/no pen \&/or money following a second invite (branded vs unbranded incentive) * 0/1 of these incentives vs. receiving 2/3 incentives following a second invite. * Difference in proportion of patients completing study elements comparing: * 0/1 vs 2/3 incentives. * those receiving pre vs post invitation incentives.
Recruitment status
COMPLETED
Target enrollment
234 participants
Primary outcome timeframe
average 2 weeks
Results posted on
2024-01-08
Participant Flow
Patients were invited to participate in the study by letter given to them at their clinic appointment by their clinician.
Participant milestones
| Measure |
Myeloproliferative Neoplasm Case
Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.
Exclusion Criteria
* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
Methodological trolley tokens: Trolley tokens to be randomly assigned to half of cases and General Practice controls.
|
General Practice Control
For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.
The following patient groups will be excluded. Those:
* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
Methodological trolley tokens: Trolley tokens to be randomly assigned to half
|
Non-blood Relative or Family Control
Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
|
|---|---|---|---|
|
Overall Study
STARTED
|
106
|
47
|
81
|
|
Overall Study
Methodological Pens
|
69
|
29
|
54
|
|
Overall Study
Methodological Trolley Token
|
51
|
16
|
0
|
|
Overall Study
Methodological - £10 Cheque
|
57
|
23
|
42
|
|
Overall Study
Initial Contact - Consent
|
84
|
35
|
81
|
|
Overall Study
Second Invite - Consent
|
22
|
11
|
0
|
|
Overall Study
COMPLETED
|
106
|
45
|
81
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Myeloproliferative Neoplasm Case
Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.
Exclusion Criteria
* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
Methodological trolley tokens: Trolley tokens to be randomly assigned to half of cases and General Practice controls.
|
General Practice Control
For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.
The following patient groups will be excluded. Those:
* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
Methodological trolley tokens: Trolley tokens to be randomly assigned to half
|
Non-blood Relative or Family Control
Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Myeloproliferative Neoplasms: an In-depth Case-control Study
Baseline characteristics by cohort
| Measure |
Myeloproliferative Neoplasm Case
n=106 Participants
The letters inviting participants to participate in the study were randomised to contain:
* a branded pen, an unbranded pen or no pen
* a trolley token
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.
|
General Practice Control
n=45 Participants
The letters inviting participants to participate in the study were randomised to contain:
* a branded pen, an unbranded pen or no pen
* a trolley token
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.
|
Non-blood Relative Family Control
n=81 Participants
The letters inviting participants to participate in the study were randomised to contain:
* a branded pen, an unbranded pen or no pen
* Information in the study information leaflet that £10 compensation cheque would be provided upon completion and details in the letter that compensation would be provided vs no mention of compensation in the information booklet or invitation letter.
|
Total
n=232 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
128 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
104 Participants
n=7 Participants
|
|
Age, Continuous
|
63.28 years
STANDARD_DEVIATION 12.50 • n=99 Participants
|
62.10 years
STANDARD_DEVIATION 9.77 • n=107 Participants
|
59.90 years
STANDARD_DEVIATION 13.52 • n=206 Participants
|
61.87 years
STANDARD_DEVIATION 12.44 • n=7 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
142 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
90 Participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
106 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
232 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: average 2 weeks* Difference in participation rates in those receiving: * vs. not receiving a pen at initial contact. * vs. not receiving a trolley token at initial contact. * vs. not receiving a monetary incentive at initial contact. * a MOSAICC pen vs. a non-branded pen following second contact. * vs. not receiving a trolley token following second contact. * a MOSAICC branded Pen +/or trolley token alone vs no non-monetary incentive following a second invite. * a MOSAICC branded Pen +/or trolley token alone vs no incentive following a second invite. * a MOSAICC branded Pen +/or trolley token alone vs pen/no pen \&/or money following a second invite (branded vs unbranded incentive) * 0/1 of these incentives vs. receiving 2/3 incentives following a second invite. * Difference in proportion of patients completing study elements comparing: * 0/1 vs 2/3 incentives. * those receiving pre vs post invitation incentives.
Outcome measures
| Measure |
Myeloproliferative Neoplasm Case
n=106 Participants
Patients with Polycythemia vera (PV), essential thrombocythemia (ET) and primary myelofibrosis (PMF) will be recruited based on the WHO diagnostic criteria.
Exclusion Criteria
* younger than 18 years old.
* where the clinician/General Practitioner (GP) does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate.
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
Methodological trolley tokens: Trolley tokens to be randomly assigned to half of cases and General Practice controls.
|
General Practice Control
n=45 Participants
For each MPN case one GP control will be randomly selected and frequency matched to the distribution of cases by 5-year age band, geographic location (Belfast and Southampton) and gender.
The following patient groups will be excluded. Those:
* younger than 18 years old.
* where the clinician/GP does not provide consent.
* incapable of giving informed consent.
* physically or cognitively incapable of completing the questionnaire.
* too ill to participate. The WHO performance evaluation scale will be used at the stage of participant identification. Only those scoring 0-3 will be considered eligible for inclusion in the study. Those scoring 3 are described as "Symptomatic \>50% in bed but not bedbound".
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
Methodological trolley tokens: Trolley tokens to be randomly assigned to half
|
Non-blood Relative or Family Control
n=81 Participants
Recruitment of 100 non-blood relative/friend controls will be undertaken by asking cases to pass on a flyer to up to 2 or 3 non-blood relatives/friends aged 18 years or older.
Methodological pens: Randomisation of branded pen, non-branded pen and no pen
Methodological compensation: Randomisation of a £10 monetary reimbursement for expenses on completion of the study
|
|---|---|---|---|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. of Participants who didn't receive an incentive
|
4 Participants
|
6 Participants
|
15 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. of participants who got pen - INITIAL CONTACT
|
69 Participants
|
28 Participants
|
54 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. participants got TrolleyToken- INITIAL CONTACT
|
51 Participants
|
16 Participants
|
0 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. participants got compensation -INITIAL CONTACT
|
57 Participants
|
22 Participants
|
42 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. who got Mosaicc pen- INITIAL CONTACT
|
32 Participants
|
17 Participants
|
26 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. who got Pre-incentive (pen and/or trolley token) only- INITIAL CONTACT
|
45 Participants
|
17 Participants
|
24 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. who got compensation only- INITIAL CONTACT
|
13 Participants
|
3 Participants
|
12 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. who got pre & post incentive e.g. pen, trolley token and compensation - INITIAL CONTACT
|
44 Participants
|
19 Participants
|
30 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No of participants after second invite who initially received a Normal pen
|
10 Participants
|
2 Participants
|
0 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. who got Normal pen-INITIAL CONTACT
|
37 Participants
|
11 Participants
|
28 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No. of participants who got 0 or 1 incentive- INITIAL CONTACT
|
46 Participants
|
22 Participants
|
51 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No of participants 2or 3 incentives(F/F controls could only receive a max of 2 incentives) - INITIAL
|
60 Participants
|
23 Participants
|
30 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No who participated after the second invite
|
24 Participants
|
10 Participants
|
0 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No of participants after second invite who initially received a MOSAICC pen
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Influence of Pre- and Post- Incentives on Participation Rates.
No of participants after second invite who initially received a Trolley token
|
14 Participants
|
6 Participants
|
0 Participants
|
Adverse Events
Myeloproliferative Neoplasm Case
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Practice Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-blood Relative or Family Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place