ACTIVE_NOT_RECRUITING

RCT Evaluating Standardized Counseling on Early Discontinuation for Irregular Bleeding in Nexplanon Users

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Clinician counseling for implant users should involve an explanation of the likelihood of irregular bleeding and the possibility of continued or frequent bleeding throughout three years of use. If that counseling does not provide specifics of the actual distribution of bleeding patterns described in published literature, there remains the real possibility of biased or directed counseling, leading to an inaccurate and exaggerated expectation of potential bleeding changes. This study aims to evaluate if a standardized script accompanied by a visual aid regarding expected bleeding profiles, with intention to remove any possibility of negative or positive framing, could change users' expectations and satisfaction with their method, leading to lower discontinuation rates.

Official Title

Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant

Quick Facts

Study Start:2020-11-24
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04558229

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.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Presenting at the health center to receive an etonogestrel-releasing subdermal implant (Nexplanon) for primarily contraceptive benefits
  2. * Ability to consent in English
  1. * Have used an etonogestrel-releasing subdermal implant (Nexplanon) within the 12 weeks prior to enrollment

Contacts and Locations

Principal Investigator

Colleen P McNicholas, DO, MSCI
PRINCIPAL_INVESTIGATOR
Planned Parenthood of the St. Louis Region and Southwest Missouri

Study Locations (Sites)

Planned Parenthood of the St. Louis Region and Southwest Missouri
St. Louis, Missouri, 63108
United States

Collaborators and Investigators

Sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri

  • Colleen P McNicholas, DO, MSCI, PRINCIPAL_INVESTIGATOR, Planned Parenthood of the St. Louis Region and Southwest Missouri

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 Registration Dates

Study Start Date2020-11-24
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2020-11-24
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • Contraceptive implant
  • Birth control
  • Nexplanon

Additional Relevant MeSH Terms

  • Birth Control
  • Contraception
  • Contraceptive Usage
  • Family Planning