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

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04081779

Collaborator

National Cancer Institute (NCI) (NIH)

100

Enrollment

Location

Arms

42.3

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma Colorectal Carcinoma Lung Carcinoma Lymphoma Prostate Carcinoma	Other: Survivorship Care Plan Other: Educational Intervention Other: Questionnaire Administration	N/A

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.

After completion of study, patients are followed up at approximately 8 weeks.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Masking Description:

Personnel other than the statisticians and lay health educators

Primary Purpose:

Supportive Care

Official Title:

IMPACT: Improving Access to Cancer Survivorship Via Telehealth

Actual Study Start Date :

Feb 19, 2020

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm I (patient-generated SCP) Patients receive a self-generated SCP (i.e., generated from baseline questionnaire responses).	Other: Survivorship Care Plan Receive patient-generated SCP Other: Questionnaire Administration Ancillary studies
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: 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 Other: Questionnaire Administration Ancillary studies

Arm

Intervention/Treatment

Active Comparator: Arm I (patient-generated SCP)

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

Other: Survivorship Care Plan

Receive patient-generated SCP

Other: Questionnaire Administration

Ancillary studies

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: 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

Other: Questionnaire Administration

Ancillary studies

Outcome Measures

Primary Outcome Measures

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 [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

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 at Washington, Wyoming, Alaska, Montana and Idaho-region Practice and Research Network (WPRN) clinics will be contacted about participating in the study after participant enrollment into the 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)