Evaluating Factors In Study Experiences of Lymphedema Patients

July 7, 2023 updated by: Power Life Sciences Inc.

Exploring the Real-life Stories of Individuals Enrolled in Lymphedema Clinical Trials

The study intends to investigate the personal experiences of lymphedema patients who take part in a separate clinical trial including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.

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

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with lymphedema who are actively considering enrolling in an interventional clinical trial for said condition, but have not yet completed enrollment and randomization phases in said clinical trial.

Description

Inclusion Criteria:

  • Patients diagnosed with lymphedema
  • Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
  • Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

Exclusion Criteria:

  • Refusal of consent
  • Women of childbearing potential without a negative pregnancy test; or women who are lactating.
  • Any serious and/or unstable pre-existing medical disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who decide to enroll in a lymphedema clinical trial
Time Frame: 3 months
3 months
Rate of patients who remain in lymphedema clinical trial to trial completion
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Power Life Sciences Inc.

Investigators

  • Study Director: Michael B Gill, Power Life Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 7, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

July 17, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83474689

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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