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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-19

Study Completion Date

2026-03-31

Brief Summary

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This trial studies how well self-generated survivorship care plans and telehealth education works in improving knowledge and self-efficacy in cancer survivors living in rural areas. Patients living in rural areas often face barriers to survivorship care and report unmet needs. A survivorship care plan created by the patient (self-generated) may help them to better transition from oncology to primary care and improve communication between care teams in order to meet these needs and create better health outcomes. Telehealth is a way of delivering health care services from a distance, including patient education. Combining a self-generated survivorship care plan with telehealth education may help to improve knowledge and self-efficacy in cancer survivors.

Detailed Description

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OUTLINE:

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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Breast Carcinoma Colorectal Carcinoma Lung Carcinoma Lymphoma Prostate Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators
Personnel other than the statisticians and lay health educators

Study Groups

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Arm I (patient-generated SCP)

Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).

Group Type ACTIVE_COMPARATOR

Survivorship Care Plan

Intervention Type OTHER

Receive patient-generated SCP

Questionnaire Administration

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Survivorship Care Plan

Intervention Type OTHER

Receive patient-generated SCP

Educational Intervention

Intervention Type OTHER

Receive telephone-based educational counseling session

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Arm III (generic information)

Patients receive generic information on survivorship care on study.

Group Type ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Supportive Care

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Survivorship Care Plan

Intervention Type OTHER

Receive patient-generated SCP

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Supportive Care

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Survivorship Care Plan

Intervention Type OTHER

Receive patient-generated SCP

Educational Intervention

Intervention Type OTHER

Receive telephone-based educational counseling session

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Supportive Care

Intervention Type OTHER

Receive generic information on survivorship care

Interventions

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Survivorship Care Plan

Receive patient-generated SCP

Intervention Type OTHER

Educational Intervention

Receive telephone-based educational counseling session

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Supportive Care

Receive generic information on survivorship care

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Supportive Therapy Symptom Management

Eligibility Criteria

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Inclusion Criteria

* Cancer survivors who have completed curative therapy within the past 5 years (may still currently be on long-term/targeted non-cytotoxic agent maintenance therapy, e.g., tamoxifen or aromatase inhibitors for breast cancer survivors; androgen deprivation therapy for prostate cancer survivors)
* 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

* Currently on palliative or hospice care, or considering transferring to such care within the next 3 months
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 41087806 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39955465 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36593127 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2019-05726

Identifier Type: REGISTRY

Identifier Source: secondary_id

10267

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21CA258105

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RG1005815

Identifier Type: -

Identifier Source: org_study_id

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