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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673083
• Other study ID #: All4Cure02
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 2025

Study information

• Verified date: June 2024
• Source: All4Cure
• Contact: Carl A Blau, MD
• Phone: 206-412-1787
• Email: tony[@]all4cure.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma in Relapse
• Multiple Myeloma With Failed Remission
• Multiple Myeloma, Refractory
• Neoplasms, Plasma Cell

Locations

Country	Name	City	State
United States	Misson Cancer + Blood	Des Moines	Iowa
United States	Hematology-Oncology Associates of Central New York	East Syracuse	New York
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Northwest Medical Specialties PLLC	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
All4Cure	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate associations between Patient Activation and symptom burden	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
Secondary	Evaluate the feasibility and acceptability of participation in All4Cure's digital platform for survivors with multiple myeloma	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