Back to results

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

Primary Purpose

Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Survivorship Care Plan

Educational Intervention

Questionnaire Administration

About this trial

This is an interventional supportive care trial for Breast Carcinoma focused on measuring Cancer survivors, survivorship care plans, primary care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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 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.
LOCAL ONCOLOGY CLINIC STAFF: Oncologists, nurse practitioners, physician's assistants, and 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)

Sites / Locations

Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (patient-generated SCP)

Arm II (patient-generated SCP, educational counseling)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Initial participation rate of cancer survivors identified from community-based practices

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.

Proportion of survivors who receive the phone-based education session within the study time period

Proportion of survivors who complete the follow-up questionnaire within the study time period

Response rate among primary care providers (PCPs) to the PCP survey

Secondary Outcome Measures

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.

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.

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.

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

Full Information

NCT ID

NCT04081779

First Posted

August 29, 2019

Last Updated

September 1, 2023

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT04081779

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

February 19, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Carcinoma, Colorectal Carcinoma, Lung Carcinoma, Lymphoma, Prostate Carcinoma

Keywords

Cancer survivors, survivorship care plans, primary care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigator

Masking Description

Personnel other than the statisticians and lay health educators

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm I (patient-generated SCP)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm II (patient-generated SCP, educational counseling)

Arm Type

Experimental

Arm 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.

Intervention Type

Other

Intervention Name(s)

Survivorship Care Plan

Intervention Description

Receive patient-generated SCP

Intervention Type

Other

Intervention Name(s)

Educational Intervention

Other Intervention Name(s)

Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Intervention Description

Receive telephone-based educational counseling session

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Initial participation rate of cancer survivors identified from community-based practices

Time Frame

Up to 8 weeks

Title

Accuracy of survivors' self-generated survivorship care plans (SCPs) in relation to those based on medical record abstraction

Description

Time Frame

Up to 8 weeks

Title

Proportion of survivors who receive the phone-based education session within the study time period

Time Frame

Up to 8 weeks

Title

Proportion of survivors who complete the follow-up questionnaire within the study time period

Time Frame

Up to 8 weeks

Title

Response rate among primary care providers (PCPs) to the PCP survey

Time Frame

Up to 8 weeks

Secondary Outcome Measure Information:

Title

Participant perceived self-efficacy: questionnaire using the PROMIS Global 10 and health related self-efficacy scales

Description

Time Frame

Up to 8 weeks

Title

Survivorship knowledge

Description

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.

Time Frame

Up to 8 weeks

Title

PCP self-efficacy towards survivorship care

Description

Time Frame

Up to 8 weeks

Title

Local oncology clinics' attitudes towards survivorship care implementation

Description

Time Frame

Up to 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Chow

Organizational Affiliation

Fred Hutch/University of Washington Cancer Consortium

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fred Hutch/University of Washington Cancer Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs