Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05673083
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2022-12-22
Brief Title:
Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma
Sponsor:
All4Cure
Organization:
All4Cure
Study Overview
Official Title:
Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma The main question it aims to answer are
Does All4Cure effect patient activation as assessed by the PAM-13 survey
Participants will be asked to
fill out quarterly PAM-13 surveys through the All4Cure website to assess patient activation
fill out monthly Patient Reported Outcome PRO surveys through the All4Cure website
fill out a baseline and exit All4Cure surveys through the All4Cure website to assess patient perceptions of All4Cure at the beginning and the end of the study
Does All4Cure effect patient activation as assessed by the PAM-13 survey
Participants will be asked to
fill out quarterly PAM-13 surveys through the All4Cure website to assess patient activation
fill out monthly Patient Reported Outcome PRO surveys through the All4Cure website
fill out a baseline and exit All4Cure surveys through the All4Cure website to assess patient perceptions of All4Cure at the beginning and the end of the study
Detailed Description:
The goal of this pilot study is to evaluate the impact of All4Cure enrollment on patients with multiple myeloma
This study uses surveys to assess attitudes and perceptions of patients with myeloma at baseline and following their enrollment into All4Cure The PAM-13 surveys will be administered at baseline and at 3-month intervals for a total of 5 surveys over 12 months Patient attitudes and perceptions about the All4Cure platform will be assessed at baseline and at 12 months Physicians caring for patients enrolled in this study will be surveyed twice -- at baseline and when all their patients have completed the study Additionally all patients will receive monthly surveys to assess symptoms associated with myeloma and its treatment using 36 survey items obtained from Patient Reported Outcomes PRO-Common Terminology Criteria for Adverse Events CTCAE
The study has the following objectives
Primary objective To evaluate the impact of All4Cure enrollment on patients with multiple myeloma The primary endpoint is the effect of All4Cure on patient activation as assessed by the PAM-13 survey change in results from baseline survey to the last completed survey
Secondary objectives
To evaluate the feasibility ie 50 approach-to-enrollment rate of eligible participants and 70 completion of at least two PAM-13 surveys over a 12-month period and acceptability ie 20 withdrawing from the study and 20 withdrawing from All4Cure of participation in All4Cures digital platform for survivors with multiple myeloma
To evaluate associations between participant activation levels as assessed by PAM-13 and symptom burden as measured by the Patient Reported Outcomes PRO-Common Terminology Criteria for Adverse Events CTCAE
To evaluate patient expectations and perceptions of the utility of All4Cure in their care and their association with PAM-13 results
To evaluate associations between patient participation in the All4Cure platform eg patient visits to the platform patient posts on the platform All4Cure posts on patient dashboards and provision of MyelomaMap reports and PAM-13 results
To evaluate physician expectations and perceptions of the utility of All4Cure in their care of patients with multiple myeloma and their association with the PAM-13 results of their patients
This study uses surveys to assess attitudes and perceptions of patients with myeloma at baseline and following their enrollment into All4Cure The PAM-13 surveys will be administered at baseline and at 3-month intervals for a total of 5 surveys over 12 months Patient attitudes and perceptions about the All4Cure platform will be assessed at baseline and at 12 months Physicians caring for patients enrolled in this study will be surveyed twice -- at baseline and when all their patients have completed the study Additionally all patients will receive monthly surveys to assess symptoms associated with myeloma and its treatment using 36 survey items obtained from Patient Reported Outcomes PRO-Common Terminology Criteria for Adverse Events CTCAE
The study has the following objectives
Primary objective To evaluate the impact of All4Cure enrollment on patients with multiple myeloma The primary endpoint is the effect of All4Cure on patient activation as assessed by the PAM-13 survey change in results from baseline survey to the last completed survey
Secondary objectives
To evaluate the feasibility ie 50 approach-to-enrollment rate of eligible participants and 70 completion of at least two PAM-13 surveys over a 12-month period and acceptability ie 20 withdrawing from the study and 20 withdrawing from All4Cure of participation in All4Cures digital platform for survivors with multiple myeloma
To evaluate associations between participant activation levels as assessed by PAM-13 and symptom burden as measured by the Patient Reported Outcomes PRO-Common Terminology Criteria for Adverse Events CTCAE
To evaluate patient expectations and perceptions of the utility of All4Cure in their care and their association with PAM-13 results
To evaluate associations between patient participation in the All4Cure platform eg patient visits to the platform patient posts on the platform All4Cure posts on patient dashboards and provision of MyelomaMap reports and PAM-13 results
To evaluate physician expectations and perceptions of the utility of All4Cure in their care of patients with multiple myeloma and their association with the PAM-13 results of their patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None