Clinical trial NCT05673083: Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma
Official title: Impact of a Health Technology Intervention on Patient Activation in Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma in Relapse
Multiple Myeloma
Multiple Myeloma, Refractory
Multiple Myeloma with Failed Remission
Keywords: Multiple Myeloma
All4Cure
Patient Activation
PAM-13
Lead sponsor: All4Cure
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2023-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility 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.

Primary outcomes:
measure: Patient Activation
timeFrame: 24 months
Secondary outcomes:
measure: Evaluate associations between Patient Activation and symptom burden
timeFrame: 24 months
measure: Evaluate the feasibility and acceptability of participation in All4Cure's digital platform for survivors with multiple myeloma
timeFrame: 24 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Des Moines
country: United States
facility: Misson Cancer + Blood
state: Iowa
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of Central New York
state: New York
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute
state: Oklahoma
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Tacoma
country: United States
facility: Northwest Medical Specialties PLLC
state: Washington
Study officials:
References: