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

Last updated: November 21, 2024
Sponsor: All4Cure
Overall Status: Active - Recruiting

Phase

N/A

Condition

Red Blood Cell Disorders

Multiple Myeloma

Bone Neoplasm

Treatment

N/A

Clinical Study ID

NCT05673083
All4Cure02
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 athome, at work, at the oncologist's office or elsewhere).

  7. are cared for by a physician who is enrolled in All4Cure.

Exclusion

Exclusion Criteria:

  1. Patients will be excluded who are unable to engage with All4Cure or are alreadyparticipants in All4Cure.

Study Design

Total Participants: 200
Study Start date:
March 01, 2023
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • Highlands Oncology Group

    Fayetteville, Arkansas 72703
    United States

    Site Not Available

  • Cancer Specialists of North Florida

    Jacksonville, Florida 32003
    United States

    Site Not Available

  • Misson Cancer + Blood

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Hematology-Oncology Associates of Central New York

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Oklahoma Cancer Specialists and Research Institute

    Tulsa, Oklahoma 74146
    United States

    Active - Recruiting

  • Oncology Consultants

    Houston, Texas 77030
    United States

    Site Not Available

  • Northwest Medical Specialties PLLC

    Tacoma, Washington 98405
    United States

    Site Not Available

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