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

Study 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 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.

Official Title
-----------------
IMPACT: Improving Access to Cancer Survivorship Via Telehealth

Conditions
-----------------
Lung Carcinoma, Breast Carcinoma, Colorectal Carcinoma, Lymphoma, Prostate Carcinoma

Intervention / Treatment
-----------------
* Other: Survivorship Care Plan
* Other: Educational Intervention
* Other: Questionnaire Administration


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer survivors, survivorship care plans, primary care