Survivorship Care Plans and Telehealth Education for the Improvement of Access to Cancer Survivorship, the IMPACT Study
NCT ID: NCT04081779
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
261 participants
INTERVENTIONAL
2020-02-19
2026-03-31
Brief Summary
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Detailed Description
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Patients complete a questionnaire at baseline (paper, online, or telephone-based) and have medical records reviewed and are assigned to 1 of 3 cohorts.
COHORTS A AND B: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).
ARM II: Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.
COHORT C: Patients are randomized to 1 of 3 arms.
ARM III: Patients receive generic information on survivorship care on study.
ARM IV: Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.
ARM V: Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.
PRIMARY CARE PROVIDERS: Primary care providers complete a questionnaire about perceptions of the SCP and self-efficacy in providing survivorship care.
ONCOLOGY CLINICS: Participants complete Organizational Readiness to Change Assessment (ORCA) questionnaire and participate in a qualitative interview about perceptions of implementation of survivorship care.
After completion of study, patients are followed up at approximately 8 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Arm I (patient-generated SCP)
Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).
Survivorship Care Plan
Receive patient-generated SCP
Questionnaire Administration
Ancillary studies
Arm II (patient-generated SCP, counseling)
Patients receive a self-generated SCP as in Arm I. Patients also receive a 30-minute telephone-based educational counseling session on survivorship care administered by trained lay health counselors.
Survivorship Care Plan
Receive patient-generated SCP
Educational Intervention
Receive telephone-based educational counseling session
Questionnaire Administration
Ancillary studies
Arm III (generic information)
Patients receive generic information on survivorship care on study.
Questionnaire Administration
Ancillary studies
Supportive Care
Receive generic information on survivorship care
Arm IV (generic information, patient-generated SCP)
Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.
Survivorship Care Plan
Receive patient-generated SCP
Questionnaire Administration
Ancillary studies
Supportive Care
Receive generic information on survivorship care
Arm V (generic information, patient-generated SCP, counseling)
Patients receive generic information on survivorship care as well as a self-generated SCP as in Arm I and a telephone-based educational counseling session as in Arm II on study.
Survivorship Care Plan
Receive patient-generated SCP
Educational Intervention
Receive telephone-based educational counseling session
Questionnaire Administration
Ancillary studies
Supportive Care
Receive generic information on survivorship care
Interventions
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Survivorship Care Plan
Receive patient-generated SCP
Educational Intervention
Receive telephone-based educational counseling session
Questionnaire Administration
Ancillary studies
Supportive Care
Receive generic information on survivorship care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of either adult-onset (age \>= 18) lymphoma, breast, colorectal, lung, or prostate cancer
* Able to perform all study requirements, including responding to questionnaires
* Willing to be randomized
* Capable of providing informed consent
* Consent to release oncology and primary care medical records
* English or Spanish speakers
* PRIMARY CARE PROVIDERS: PCPs responsible for delivering primary care to IMPACT study participants will be contacted about participating in the study after participant enrollment into the study.
* ONCOLOGY STAFF: Oncology Staff (Oncologists, Nurse Practitioners, Physician's assistants) will be recruited from sites involved in the IMPACT study
* CLINIC ADMINISTRATORS: Clinic administrators will be recruited from sites involved in the IMPACT study
Exclusion Criteria
* Lacks telephone access
* Lacks mailing address or ability to receive study materials electronically
* Currently being followed in a pediatric clinical setting (either for primary care or for cancer care)
* History of having had \> 1 cancer type diagnosed and treated (exception is for skin cancers treated with surgical excision alone; also, individuals who only have had relapse of their initial cancer remain eligible so long as they have completed curative therapy and meet all other eligibility criteria)
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eric Chow
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Yi JC, Lee E, Duggan C, Baker KS, Blythe N, Cole AM, Cushing-Haugen KL, Gutierrez AI, Linden H, Mendoza JA, Ohlsen TJD, Ortblad KF, Schwartz SM, Yung R, Ceballos R, Chow EJ. Perspective of Hispanic Cancer Survivors on Survivorship Care Plans: A Qualitative Study. J Immigr Minor Health. 2025 Oct 14. doi: 10.1007/s10903-025-01794-8. Online ahead of print.
Chow EJ, Blythe NA, Cushing-Haugen KL, Duggan C, Baker KS, Cole AM, Green S, Guiterrez AI, Lee E, Linden HM, Mendoza JA, Ohlsen TJD, Ortblad KF, Schwartz SM, Yung RL, Ceballos RM. Enhancing survivorship care among Hispanic/Latino cancer survivors via lay health educators: results of a pilot randomized trial. J Cancer Surviv. 2025 Feb 15:10.1007/s11764-025-01758-9. doi: 10.1007/s11764-025-01758-9. Online ahead of print.
Duggan C, Cushing-Haugen KL, Cole AM, Allen J, Gilles R, Hornecker JR, Gutierrez AI, Warner J, Baker KS, Ceballos RM, Chow EJ. Feasibility of delivering survivorship care via lay health educators: A pilot randomized controlled trial among rural cancer survivors. J Rural Health. 2023 Jun;39(3):666-675. doi: 10.1111/jrh.12736. Epub 2023 Jan 2.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2019-05726
Identifier Type: REGISTRY
Identifier Source: secondary_id
10267
Identifier Type: OTHER
Identifier Source: secondary_id
RG1005815
Identifier Type: -
Identifier Source: org_study_id
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