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

Lymphoma Clinical Trial

Official title:

IMPACT: Improving Access to Cancer Survivorship Via Telehealth

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04081779
• Other study ID #: RG1005815
• Secondary ID: NCI-2019-0572610
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 19, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Lung Carcinoma
• Lymphoma
• Prostate Carcinoma

Intervention

Other:
• Survivorship Care Plan
Receive patient-generated SCP
• Educational Intervention
Receive telephone-based educational counseling session
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial participation rate of cancer survivors identified from community-based practices		Up to 8 weeks
Primary	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
Primary	Proportion of survivors who receive the phone-based education session within the study time period		Up to 8 weeks
Primary	Proportion of survivors who complete the follow-up questionnaire within the study time period		Up to 8 weeks
Primary	Response rate among primary care providers (PCPs) to the PCP survey		Up to 8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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