Clinical trial NCT04081779: Survivorship Care Plans and Telehealth Education for the Improvement of Access to Cancer Survivorship, the IMPACT Study
Official title: IMPACT: Improving Access to Cancer Survivorship Via Telehealth
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Carcinoma
Colorectal Carcinoma
Lung Carcinoma
Lymphoma
Prostate Carcinoma
Keywords: Cancer survivors
survivorship care plans
primary care
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-09-09
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Initial participation rate of cancer survivors identified from community-based or partner practices, and Cancer Surveillance System of Western Washington
timeFrame: Up to 8 weeks
measure: Accuracy of survivors' self-generated survivorship care plans (SCPs) in relation to those based on medical record abstraction
timeFrame: Up to 8 weeks
measure: Proportion of survivors who receive the phone-based education session within the study time period
timeFrame: Up to 8 weeks
measure: Proportion of survivors who complete the follow-up questionnaire within the study time period
timeFrame: Up to 8 weeks
measure: Response rate among primary care providers (PCPs) to the PCP survey
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales
timeFrame: Up to 8 weeks
measure: Survivorship knowledge
timeFrame: Up to 8 weeks
measure: PCP self-efficacy towards survivorship care
timeFrame: Up to 8 weeks
measure: Local oncology clinics' attitudes towards survivorship care implementation
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Eric Chow
role: PRINCIPAL_INVESTIGATOR
References: