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OpenTrials
Active, Not Recruiting

NCT Number: NCT04765072

Expanding Rural Health Cancer Control Capacity

Through this pilot study, investigators will test an innovative approach to implement survivorship care planning at three sites located in or adjacent to rural counties. The pilot data will inform a subsequent multi-site Hybrid Type 3 Implementation-Effectiveness study that will assess both implementation and clinical effectiveness outcomes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Cancer Center- Golden Triangle Columbus, Columbus, Mississippi, United States

Loading trial locations.

About this study

Study Aims:

  • Pilot test the implementation of guideline-based survivorship care planning in a rural setting using patient navigation plus telehealth among underserved rural cancer survivors. Investigators will collect feasibility data on patient recruitment rates and the ability to measure clinical effectiveness outcomes using the electronic health record and patient reports (survivor adherence to recommended disease surveillance, health assessment and cancer prevention/early detection practices).
  • Identify the facilitators and barriers to future larger scale implementation of guideline-based survivorship care planning in rural settings to optimize the implementation strategies. Through a mixed methods approach, investigators will address implementation research questions focused on "real world" implementation of the guideline-based intervention in rural areas, including barriers/facilitators and translation to other rural settings. This will allow us to optimize the implementation strategies that will be further evaluated in the future large-scale implementation trial

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Cancer patient at least 18 years of age at time of cancer therapy
  • English-speaking with the ability to provide informed consent
  • Received treatment for Stage 0 - III cancer with curative intent
  • Completed cancer therapy within the previous 12 months (i.e., 12 months prior to consenting) and in complete remission

Treatment and study plan

Survivorship Patient Navigation Intervention

Behavioral

Patient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources

Telehealth Survivorship Visit Intervention

Behavioral

Individualized survivorship care plan

Primary outcomes

  1. Rate of improvement in adherence to survivorship plan (Survivorship Care Planning Experience Satisfaction Survey (1-5 Excellent - Poor)

    Time frame: Approximately 12 months

  2. Measure effectiveness of Telehealth on survivorship care

    Time frame: Approximately 12 months

  3. Estimate the facilitators to a future larger-scale implementation of guideline-based survivorship care planning in rural settings

    Time frame: Approximately 1 year

  4. Estimate the barriers to a future larger-scale implementation of guideline-based survivorship care planning in rural settings

    Time frame: Approximately 1 year

Sponsors and collaborators

Lead sponsor

Debra Friedman

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Expanding Rural Health Cancer Control Capacity: Focus on Cancer Survivorship

Important dates

Study start
2021
Primary completion
2028
Study completion
2029
First posted
Feb 21, 2021
Registry last updated
Nov 15, 2024

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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