## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** RG1005815
#### Organization
**Class:** OTHER
**Full Name:** Fred Hutchinson Cancer Center
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2019-05726
**Type:** REGISTRY
**Domain:** Fred Hutch/University of Washington Cancer Consortium
**ID:** 10267
**Type:** OTHER
**ID:** P30CA015704
**Link:** https://reporter.nih.gov/quickSearch/P30CA015704
**Type:** NIH
**ID:** R21CA258105
**Link:** https://reporter.nih.gov/quickSearch/R21CA258105
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-11

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-09

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-02-19

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2019-09-09
**Type:** ACTUAL
**Study First Submit Date:** 2019-08-29
**Study First Submit QC Date:** 2019-09-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Fred Hutchinson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Breast Carcinoma

- Colorectal Carcinoma

- Lung Carcinoma

- Lymphoma

- Prostate Carcinoma

**Keywords:**

- Cancer survivors

- survivorship care plans

- primary care

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** Personnel other than the statisticians and lay health educators

**Who Masked:**

- CARE_PROVIDER

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Survivorship Care Plan

- Other: Questionnaire Administration

**Label:** Arm I (patient-generated SCP)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**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 Names:**

- Other: Survivorship Care Plan

- Other: Educational Intervention

- Other: Questionnaire Administration

**Label:** Arm II (patient-generated SCP, educational counseling)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arm I (patient-generated SCP)

- Arm II (patient-generated SCP, educational counseling)

**Description:** Receive patient-generated SCP

**Name:** Survivorship Care Plan

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Arm II (patient-generated SCP, educational counseling)

**Description:** Receive telephone-based educational counseling session

**Name:** Educational Intervention

**Other Names:**

- Education for Intervention

- Intervention by Education

- Intervention through Education

- Intervention, Educational

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Arm I (patient-generated SCP)

- Arm II (patient-generated SCP, educational counseling)

**Description:** Ancillary studies

**Name:** Questionnaire Administration

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** Up to 8 weeks

**Description:** 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.

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

**Time Frame:** Up to 8 weeks

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

**Time Frame:** Up to 8 weeks

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

**Time Frame:** Up to 8 weeks

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

**Time Frame:** Up to 8 weeks

#### Secondary Outcomes

**Description:** 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.

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

**Time Frame:** Up to 8 weeks

**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.

**Measure:** Survivorship knowledge

**Time Frame:** Up to 8 weeks

**Description:** 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.

**Measure:** PCP self-efficacy towards survivorship care

**Time Frame:** Up to 8 weeks

**Description:** 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

**Measure:** Local oncology clinics' attitudes towards survivorship care implementation

**Time Frame:** Up to 8 weeks

### Eligibility Module

**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)

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Seattle

**Country:** United States

**Facility:** Fred Hutch/University of Washington Cancer Consortium

**State:** Washington

**Zip:** 98109

#### Overall Officials

**Official 1:**

**Affiliation:** Fred Hutch/University of Washington Cancer Consortium

**Name:** Eric Chow

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Carcinoma

- ID: M14335

- Name: Prostatic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000015179

- Term: Colorectal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
