Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma

October 11, 2023 updated by: All4Cure

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Recruiting
        • Highlands Oncology Group
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32003
        • Recruiting
        • Cancer Specialists of North Florida
        • Contact:
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Misson Cancer + Blood
        • Contact:
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties PLLC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Activation
Time Frame: 24 months
Patient activation emphasizes patients' willingness and ability to take independent actions to manage their health and care. A widely used definition equates patient activation with understanding one's role in the care process and having the knowledge, skill, and confidence to manage one's health and health care. A growing body of evidence shows that patients who are more activated have better health outcomes and care experiences. This will be assessed through the PAM-13 survey which has a scale of 1-4, with 4 being the highest level of patient activation and associated with the best patient outcomes and 1 being the lowest level of patient activation.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate associations between Patient Activation and symptom burden
Time Frame: 24 months
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).
24 months
Evaluate the feasibility and acceptability of participation in All4Cure's digital platform for survivors with multiple myeloma
Time Frame: 24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All4Cure

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • All4Cure02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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