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

Fred Hutchinson Cancer Center (FHCC)

Status: Active, not recruiting

Conditions: Colorectal Carcinoma; Prostate Carcinoma; Lymphoma; Lung Carcinoma; Breast Carcinoma

Treatments: Other: Survivorship Care Plan; Other: Supportive Care; Other: Educational Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04081779

RG1005815

NCI-2019-05726 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

R21CA258105 (U.S. NIH Grant/Contract)

10267 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 261 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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261 participants in 5 patient groups

Arm I (patient-generated SCP)

Active Comparator group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Survivorship Care Plan

Arm II (patient-generated SCP, counseling)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Educational Intervention

Other: Survivorship Care Plan

Arm III (generic information)

Active Comparator group

Description:

Patients receive generic information on survivorship care on study.

Treatment:

Other: Questionnaire Administration

Other: Supportive Care

Arm IV (generic information, patient-generated SCP)

Active Comparator group

Description:

Patients receive generic information on survivorship care and a self-generated SCP as in Arm I on study.

Treatment:

Other: Questionnaire Administration

Other: Supportive Care

Other: Survivorship Care Plan

Arm V (generic information, patient-generated SCP, counseling)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Educational Intervention

Other: Supportive Care

Other: Survivorship Care Plan