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Enrolling by Invitation

NCT Number: NCT05400941

Aim 3, Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care

This mixed methods study evaluates the effectiveness of an organizational intervention to enhance implementation of strategies to increase breast cancer survivorship symptom and risk management.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University

New Brunswick, New Jersey, 08901, United States

About this study

Aim 3 is a hybrid type 1 effectiveness-implementation cluster randomized study with a waitlist control in 26 primary care practices. This study uses a tailored combination of practice facilitation, expert consultation, collaborative learning events, and audit and feedback as intervention strategies, and a mixed-methods comparative case study learning evaluation for primary care practices to adapt priority recommendations of evidence-based activities for breast cancer survivorship care. Intervention effectiveness will be assessed in two groups of clinics: 13 cases that will receive the implementation intervention and 13 waitlist controls. Impact of this implementation will be measured using mixed methods to assess Exploration, Preparation, Implementation and Sustainment factors related to how organizational and contextual variables affect adoption, implementation and early sustainability for provision of follow-up care, symptom, and risk management activities at 6 and 12 months post implementation. Aim 3 surveys 20 clinicians and staff members from 26 intervention practices (n=520) and conducts key informant interviews with 5 health care team members (who have participated in the survey; n=130) and 15 breast cancer survivors per practice (n=390; 5 per assessment point at baseline, 6 months and 12 months post intervention). Medical records of 20 patients with a history of breast cancer per practice per assessment point at baseline, 6 months and 12 months post intervention will be randomly selected for review (N=1,560) to assess and compare comprehensive breast cancer follow-up care outcomes. Sustainment will be measured through continued monitoring of the medical records for the 13 initial intervention practices at 18 and 24 months (N=520).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identification as a staff member or patient who has had breast cancer in a participating practice

Exclusion criteria

  • Unable to speak, understand and/or read English
  • Unable to provide informed consent

Treatment and study plan

Practice Led Intervention

Behavioral

This is a quality improvement intervention that includes learning collaboratives, practice facilitation, expert consultation and audit and feedback.

Primary outcomes

  1. Change in Comprehensive Breast Cancer Follow-up Care

    Time frame: Repeated measures at baseline, 6 months, 12 months, 18 months and 24 months

    Percent of eligible recommendations performed per patient to assess the comprehensiveness of the follow up care received

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Adapting and Implementing Evidence-based Breast Cancer Follow-up in Primary Care

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 2, 2022
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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