Clinical trial NCT06049485: Assessing the Experience of Patients Undergoing Follicular Lymphoma Clinical Research
Official title: Unveiling Follicular Lymphoma Clinical Trials: Analyzing Patient Engagement Patterns and Participation Trends
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Follicular Lymphoma
Keywords: follicular lymphoma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-09-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with follicular lymphoma who are actively considering enrolling in a medical trial for the said condition, but have not yet completed enrollment and randomization phases.

Brief summary: Historically, participation in medical studies is highly skewed towards particular demographic groups of people.

This research will invite several participants to gather a wide range of information on clinical trial experiences for follicular lymphoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of follicular lymphoma.

The data collected from this study will help improve future outcomes for all follicular lymphoma patients as well as those in under-represented demographic groups.


Eligibility criteria: Inclusion Criteria:

* Participant must be 18 years of age or older
* Patient has been diagnosed with follicular lymphoma
* Patient has access to a home internet connection in order to provide regular updates through the course of the study

Exclusion Criteria:

* Women of childbearing potential without a negative pregnancy test; or women who are lactating.
* Inability to provide written informed consent
* Patients receiving any other investigational agents

Primary outcomes:
measure: Number of patients who decide to enroll in a follicular lymphoma clinical research
timeFrame: 3 months
measure: Rate of patients who remain in a follicular lymphoma medical study to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Gueiderikh A, Ung M, Lazarovici J, Danu A, Ghez D, Saleh K, Dragani M, Noel N, Bigenwald C, Willekens C, Ribrag V, Michot JM, Martin V. Incidence, characteristics, management and outcome of patients with follicular lymphoma with tumor epidural compression, a study on 22 cases. Cancer Radiother. 2023 Sep;27(5):370-375. doi: 10.1016/j.canrad.2023.04.004. Epub 2023 May 6.
citation: Friedberg JW, Taylor MD, Cerhan JR, Flowers CR, Dillon H, Farber CM, Rogers ES, Hainsworth JD, Wong EK, Vose JM, Zelenetz AD, Link BK. Follicular lymphoma in the United States: first report of the national LymphoCare study. J Clin Oncol. 2009 Mar 10;27(8):1202-8. doi: 10.1200/JCO.2008.18.1495. Epub 2009 Feb 9.
citation: Ruella M, Filippi AR, Bruna R, Di Russo A, Magni M, Caracciolo D, Passera R, Matteucci P, Di Nicola M, Corradini P, Parvis G, Gini G, Olivieri A, Ladetto M, Ricardi U, Tarella C, Devizzi L. Addition of Rituximab to Involved-Field Radiation Therapy Prolongs Progression-free Survival in Stage I-II Follicular Lymphoma: Results of a Multicenter Study. Int J Radiat Oncol Biol Phys. 2016 Mar 15;94(4):783-91. doi: 10.1016/j.ijrobp.2015.12.019. Epub 2015 Dec 17.