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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05673083
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

All4Cure
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma in Relapse, Multiple Myeloma, Multiple Myeloma, Refractory, Multiple Myeloma With Failed Remission
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Highlands Oncology Group, Fayetteville, Arkansas

Status

Recruiting

Address

Highlands Oncology Group

Fayetteville, Arkansas, 72703

Site Contact

Cheng Zheng

chengz@all4cure.com

619-436-7716

Cancer Specialists of North Florida, Jacksonville, Florida

Status

Recruiting

Address

Cancer Specialists of North Florida

Jacksonville, Florida, 32003

Site Contact

Cheng Zheng

chengz@all4cure.com

619-436-7716

Misson Cancer + Blood, Des Moines, Iowa

Status

Recruiting

Address

Misson Cancer + Blood

Des Moines, Iowa, 50314

Site Contact

Cheng Zheng

chengz@all4cure.com

619-436-7716

Northwest Medical Specialties PLLC, Tacoma, Washington

Status

Recruiting

Address

Northwest Medical Specialties PLLC

Tacoma, Washington, 98405

Site Contact

Cheng Zheng

chengz@all4cure.com

619-436-7716