Survivorship Care Plans and Telehealth Education for the Improvement of Access to Cancer Survivorship, the IMPACT Study
- Conditions
- Colorectal CarcinomaLung CarcinomaLymphomaProstate CarcinomaBreast Carcinoma
- Interventions
- Other: Survivorship Care PlanOther: Questionnaire AdministrationOther: Educational Intervention
- Registration Number
- NCT04081779
- Lead Sponsor
- Fred Hutchinson Cancer Center
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 250
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I (patient-generated SCP) Survivorship Care Plan Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses). Arm I (patient-generated SCP) Questionnaire Administration Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses). Arm II (patient-generated SCP, educational counseling) Survivorship Care Plan 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 II (patient-generated SCP, educational counseling) Educational Intervention 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 II (patient-generated SCP, educational counseling) Questionnaire Administration 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.
- Primary Outcome Measures
Name Time Method 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 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 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
Name Time Method PCP self-efficacy towards survivorship care Up to 8 weeks 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.
Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales Up to 8 weeks 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.
Survivorship knowledge Up to 8 weeks 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.
Local oncology clinics' attitudes towards survivorship care implementation Up to 8 weeks 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
Trial Locations
- Locations (1)
Fred Hutch/University of Washington Cancer Consortium
🇺🇸Seattle, Washington, United States