Survivorship Care Plans and Telehealth Education for the Improvement of Access to Cancer Survivorship, the IMPACT Study

NCT04081779 | Completed

• 5 other identifiers: RG1005815NCI-2019-0572610267P30CA015704R21CA258105
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma; Prostate Carcinoma; Lung Carcinoma; Breast Carcinoma; Colorectal Carcinoma

Keywords

Cancer survivors; survivorship care plans; primary care

Outcome Measures

Primary Outcomes (5)

• Initial participation rate of cancer survivors identified from community-based or partner practices, and Cancer Surveillance System of Western Washington

  Up to 8 weeks

• Accuracy of survivors' self-generated survivorship care plans (SCPs) in relation to those based on medical record abstraction

  Will measure the accuracy of participants' SCPs by comparing their self-reported medical history collected via questionnaire, with data abstracted from medical records. Accuracy will be reported by percentage of missing data in the self-generated SCP compared to medical records, and percentage of incorrect data in the self-generated SCP compared to medical records.

  Up to 8 weeks

• Proportion of survivors who receive the phone-based education session within the study time period

  Up to 8 weeks

• Proportion of survivors who complete the follow-up questionnaire within the study time period

  Up to 8 weeks

• Response rate among primary care providers (PCPs) to the PCP survey

  Up to 8 weeks

Secondary Outcomes (4)

• Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales

  Up to 8 weeks

• Survivorship knowledge

  Up to 8 weeks

• PCP self-efficacy towards survivorship care

  Up to 8 weeks

• Local oncology clinics' attitudes towards survivorship care implementation

  Up to 8 weeks

Study Arms (5)

Arm I (patient-generated SCP)

ACTIVE COMPARATOR

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

Other: Survivorship Care Plan; Other: Questionnaire Administration

Arm II (patient-generated SCP, counseling)

EXPERIMENTAL

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.

Other: Survivorship Care Plan; Other: Educational Intervention; Other: Questionnaire Administration

Arm III (generic information)

ACTIVE COMPARATOR

Patients receive generic information on survivorship care on study.

Other: Questionnaire Administration; Other: Supportive Care

Arm IV (generic information, patient-generated SCP)

ACTIVE COMPARATOR

Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.

Other: Survivorship Care Plan; Other: Questionnaire Administration; Other: Supportive Care

Arm V (generic information, patient-generated SCP, counseling)

EXPERIMENTAL

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.

Other: Survivorship Care Plan; Other: Educational Intervention; Other: Questionnaire Administration; Other: Supportive Care

Interventions

Survivorship Care Plan OTHER

Receive patient-generated SCP

Arm I (patient-generated SCP); Arm II (patient-generated SCP, counseling); Arm IV (generic information, patient-generated SCP); Arm V (generic information, patient-generated SCP, counseling)

Educational Intervention OTHER

Receive telephone-based educational counseling session

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm II (patient-generated SCP, counseling); Arm V (generic information, patient-generated SCP, counseling)

Questionnaire Administration OTHER

Ancillary studies

Arm I (patient-generated SCP); Arm II (patient-generated SCP, counseling); Arm III (generic information); Arm IV (generic information, patient-generated SCP); Arm V (generic information, patient-generated SCP, counseling)

Supportive Care OTHER

Receive generic information on survivorship care

Also known as: Supportive Therapy, Symptom Management

Arm III (generic information); Arm IV (generic information, patient-generated SCP); Arm V (generic information, patient-generated SCP, counseling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (3)

• 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.

  PMID: 41087806 DERIVED

• 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.

  PMID: 39955465 DERIVED

• 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.

  PMID: 36593127 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Lymphoma; Prostatic Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Patient Care; Therapeutics

Study Officials

• Eric Chow

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Personnel other than the statisticians and lay health educators
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 9, 2019
• Study Start: February 19, 2020
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)