Trial Title:
Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma
NCT ID:
NCT05673083
Condition:
Multiple Myeloma in Relapse
Multiple Myeloma
Multiple Myeloma, Refractory
Multiple Myeloma With Failed Remission
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
All4Cure
Patient Activation
PAM-13
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
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 (i.e., ≥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 (i.e., ≤20% withdrawing from the study and ≤20% withdrawing from
All4Cure) of participation in All4Cure's 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 (e.g.
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.
Criteria for eligibility:
Study pop:
This study will enroll up to 200 patients with a diagnosis of multiple myeloma who are
receiving treatment at Cancer Specialists of North Florida (CSNF, Florida), Northwest
Medical Specialties (NWMS, Washington state), or Highlands Oncology Group (HOG,
Arkansas).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. have a diagnosis of multiple myeloma.
2. are aged 18 years and older.
3. can read and e-consent to participate in the study.
4. can speak English.
5. can complete surveys at pre-specified intervals.
6. have access to a device that would allow for the completion of surveys (including at
home, at work, at the oncologist's office or elsewhere).
7. are cared for by a physician who is enrolled in All4Cure.
Exclusion Criteria:
1. Patients will be excluded who are unable to engage with All4Cure or are already
participants in All4Cure.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Highlands Oncology Group
Address:
City:
Fayetteville
Zip:
72703
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Wren
Phone:
206-501-8354
Email:
jenniferw@all4cure.com
Facility:
Name:
Cancer Specialists of North Florida
Address:
City:
Jacksonville
Zip:
32003
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Wren
Phone:
206-501-8354
Email:
jenniferw@all4cure.com
Facility:
Name:
Misson Cancer + Blood
Address:
City:
Des Moines
Zip:
50314
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Wren
Phone:
206-501-8354
Email:
jenniferw@all4cure.com
Facility:
Name:
Hematology-Oncology Associates of Central New York
Address:
City:
East Syracuse
Zip:
13057
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Wren
Phone:
206-501-8354
Email:
jenniferw@all4cure.com
Facility:
Name:
Oklahoma Cancer Specialists and Research Institute
Address:
City:
Tulsa
Zip:
74146
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Wren
Phone:
206-501-8354
Email:
jenniferw@all4cure.com
Facility:
Name:
Oncology Consultants
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Wren
Phone:
206-501-8354
Email:
jenniferw@all4cure.com
Facility:
Name:
Northwest Medical Specialties PLLC
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Wren
Phone:
206-501-8354
Email:
jenniferw@all4cure.com
Start date:
March 1, 2023
Completion date:
March 2025
Lead sponsor:
Agency:
All4Cure
Agency class:
Industry
Collaborator:
Agency:
GlaxoSmithKline
Agency class:
Industry
Source:
All4Cure
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673083
