Evaluating Factors In Study Experiences of Lymphedema Patients

NCT05948345 | Not Yet Recruiting

• 1 other identifier: 83474689
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphedema

Keywords

Lymphedema

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to enroll in a lymphedema clinical trial

  3 months

• Rate of patients who remain in lymphedema clinical trial to trial completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• Quere I, Presles E, Coupe M, Vignes S, Vaillant L, Eveno D, Laporte S, Leizorovicz A; POLIT Study investigators. Prospective multicentre observational study of lymphedema therapy: POLIT study. J Mal Vasc. 2014 Jul;39(4):256-63. doi: 10.1016/j.jmv.2014.05.004. Epub 2014 Jun 12.

  PMID: 24931830 BACKGROUND

• Boccardo F, Santori G, Villa G, Accogli S, Dessalvi S. Long-term patency of multiple lymphatic-venous anastomoses in cancer-related lymphedema: A single center observational study. Microsurgery. 2022 Oct;42(7):668-676. doi: 10.1002/micr.30944. Epub 2022 Aug 2.

  PMID: 35916247 BACKGROUND

• Johansson K, Blom K, Nilsson-Wikmar L, Brogardh C. Early Intervention with a Compression Sleeve in Mild Breast Cancer-Related Arm Lymphedema: A 12-Month Prospective Observational Study. Cancers (Basel). 2023 May 9;15(10):2674. doi: 10.3390/cancers15102674.

  PMID: 37345010 BACKGROUND

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 17, 2023
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

US (1)