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

IMPACT: Improving Access to Cancer Survivorship Via Telehealth

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lymphoma; Breast Carcinoma; Lung Carcinoma; Colorectal Carcinoma; Prostate Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Survivorship Care Plan; Other: Educational Intervention

Detailed Description

OUTLINE:

Patients complete a questionnaire at baseline (paper, online, or telephone-based) and medical records are reviewed.

Patients are then 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.

PRIMARY CARE PROVIDERS: Primary care providers complete a questionnaire about perceptions of the SCP and self-efficacy in providing survivorship care.

ONCOLOGY CLINIC STAFF: Administrators and medical providers will be asked to complete the adapted Organizational Readiness to Change Assessment (ORCA) instrument (that measures Evidence and Context only) 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (patient-generated SCP); Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).	Other: Questionnaire Administration; Ancillary studies; Other: Survivorship Care Plan; Receive patient-generated SCP
Experimental: Arm II (patient-generated SCP, educational 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.	Other: Questionnaire Administration; Ancillary studies; Other: Survivorship Care Plan; Receive patient-generated SCP; Other: Educational Intervention; Receive telephone-based educational counseling session; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial participation rate of cancer survivors identified from community-based practices		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 Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eric Chow, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Estimated): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: primary care; Cancer survivors; survivorship care plans
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Breast Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Breast Neoplasms; Carcinoma; Colorectal Neoplasms
• Other Study ID Numbers: RG1005815; P30CA015704 (U.S. NIH Grant/Contract); NCI-2019-05726 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 10267 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); R21CA258105 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No