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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-05726 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 10267 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source | |
| R21CA258105 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (patient-generated SCP) | Active Comparator | Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses). |
|
| 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. |
|
| Arm III (generic information) | Active Comparator | Patients receive generic information on survivorship care on study. |
|
| 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. |
|
| Arm V (generic information, patient-generated SCP, counseling) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survivorship Care Plan | Other | Receive patient-generated SCP |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales | The effects of the intervention versus (vs.) control on participant perceived self-efficacy will be measured at baseline and at the end of the study via a questionnaire using the PROMIS Global 10 and health related self-efficacy scales. | Up to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Chow | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41087806 | Derived | 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. 2026 Apr;28(2):384-392. doi: 10.1007/s10903-025-01794-8. Epub 2025 Oct 14. | |
| 39955465 | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2023 | Jul 10, 2025 |
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Personnel other than the statisticians and lay health educators
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. |
|
| Educational Intervention | Other | Receive telephone-based educational counseling session |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Supportive Care | Other | Receive generic information on survivorship care |
|
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| Survivorship knowledge | The effects of the intervention vs. control on survivorship knowledge will be measured at baseline and at the end of the study via a questionnaire. | Up to 8 weeks |
| PCP self-efficacy towards survivorship care | The effects of the intervention vs. control on PCP self-efficacy towards survivorship care will be measured at baseline and at the end of the study via a questionnaire using the PROMIS Global 10 and health related self-efficacy scales. | Up to 8 weeks |
| Local oncology clinics' attitudes towards survivorship care implementation | Assess oncology practitioners' and clinic administrators' views on utility and feasibility of implementing SCPs in target clinics, using the ORCA (Organizational Readiness to Change Assessment) instrument and qualitative interviewing | Up to 8 weeks |
| 36593127 | 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. |
| ICF_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D008175 | Lung Neoplasms |
| D008223 | Lymphoma |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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