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Clinical Trials/NCT04081779
NCT04081779
Active, Not Recruiting
N/A

IMPACT: Improving Access to Cancer Survivorship Via Telehealth

Fred Hutchinson Cancer Center1 site in 1 country261 target enrollmentFebruary 19, 2020

Overview

Phase
N/A
Intervention
Survivorship Care Plan
Conditions
Breast Carcinoma
Sponsor
Fred Hutchinson Cancer Center
Enrollment
261
Locations
1
Primary Endpoint
Initial participation rate of cancer survivors identified from community-based or partner practices, and Cancer Surveillance System of Western Washington
Status
Active, Not Recruiting
Last Updated
3 months ago

Overview

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 19, 2020
End Date
March 31, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Arms & Interventions

Arm I (patient-generated SCP)

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

Intervention: Survivorship Care Plan

Arm I (patient-generated SCP)

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

Intervention: Questionnaire Administration

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.

Intervention: Survivorship Care Plan

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.

Intervention: Educational Intervention

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.

Intervention: Questionnaire Administration

Arm III (generic information)

Patients receive generic information on survivorship care on study.

Intervention: Questionnaire Administration

Arm III (generic information)

Patients receive generic information on survivorship care on study.

Intervention: Supportive 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.

Intervention: Questionnaire Administration

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.

Intervention: Supportive 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.

Intervention: Survivorship Care Plan

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.

Intervention: Survivorship Care Plan

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.

Intervention: Educational Intervention

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.

Intervention: Questionnaire Administration

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.

Intervention: Supportive Care

Outcomes

Primary Outcomes

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

Time Frame: Up to 8 weeks

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

Time Frame: Up to 8 weeks

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.

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

Time Frame: Up to 8 weeks

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

Time Frame: Up to 8 weeks

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

Time Frame: Up to 8 weeks

Secondary Outcomes

  • PCP self-efficacy towards survivorship care(Up to 8 weeks)
  • 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)
  • Local oncology clinics' attitudes towards survivorship care implementation(Up to 8 weeks)

Study Sites (1)

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