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

NCT05673083 | Active Not Recruiting

• 1 other identifier: All4Cure02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 7

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.

Conditions

Multiple Myeloma in Relapse; Multiple Myeloma; Multiple Myeloma, Refractory; Multiple Myeloma With Failed Remission

Keywords

Multiple Myeloma; All4Cure; Patient Activation; PAM-13

Outcome Measures

Primary Outcomes (1)

• Patient Activation

  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 Outcomes (2)

• Evaluate associations between Patient Activation and symptom burden

  24 months

• Evaluate the feasibility and acceptability of participation in All4Cure's digital platform for survivors with multiple myeloma

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• have a diagnosis of multiple myeloma.
• are aged 18 years and older.
• can read and e-consent to participate in the study.
• can speak English.
• can complete surveys at pre-specified intervals.
• 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).
• are cared for by a physician who is enrolled in All4Cure.

You may not qualify if:

• \. Patients will be excluded who are unable to engage with All4Cure or are already participants in All4Cure.

Sponsors & Collaborators

• All4Cure: lead
• GlaxoSmithKline: collaborator

Study Sites (7)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32003, United States

Location

Misson Cancer + Blood

Des Moines, Iowa, 50314, United States

Location

Hematology-Oncology Associates of Central New York

East Syracuse, New York, 13057, United States

Location

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 74146, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

Northwest Medical Specialties PLLC

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 6, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)