## Protocol Section
### Identification Module
**NCT ID:** NCT04268979

**Brief Title:** Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator

**Official Title:** Electronic Social Network Assessment Program (eSNAP) + Caregiver Navigator Intervention for Neuro-Oncology Couples

#### Organization Study ID Info
**ID:** MCC 19731
#### Organization
**Class:** OTHER
**Full Name:** H. Lee Moffitt Cancer Center and Research Institute
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-02

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-01

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-02-13

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2020-02-13
**Type:** ACTUAL
**Study First Submit Date:** 2020-02-11
**Study First Submit QC Date:** 2020-02-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** H. Lee Moffitt Cancer Center and Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of the study is to determine if family caregivers of neuro-oncology patients feel less burdened by utilizing the Electronic Social Network Assessment Program (eSNAP) + the Caregiver Navigator.

### Conditions Module

**Conditions:**

- Brain Cancer

**Keywords:**

- Neuro Oncology

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 225

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** eSNAP intervention plus questionnaires

**Intervention Names:**

- Behavioral: eSNAP

- Behavioral: Caregiver Navigator

**Label:** eSNAP & Caregiver Navigator

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants randomly assigned to the waitlist control condition will only complete questionnaires during the 8-week study period. After the 8 weeks, they will then have access to the eSNAP, including completion of questionnaires and 8 weeks of Caregiver Navigator sessions as needed.

**Label:** Waitlist Control Condition

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- eSNAP & Caregiver Navigator

**Description:** eSNAP is a web based tool that quickly collects and organizes social support information entered by Family Caregivers (FCGs) into visualizations of the size, quality, and function of support networks. Visualizations can help FCGs catalogue support resources and present them in a new way, which may make them more salient and remind FCGs of their availability.

**Name:** eSNAP

**Other Names:**

- Electronic Social Network Assessment Program

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- eSNAP & Caregiver Navigator

**Description:** The Caregiver Navigator will have social work training and will help Family Caregivers (FCGs) identify and leverage informal and formal social support, including enrolling or directing FCGs to services.

**Name:** Caregiver Navigator

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Caregiver well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7). The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety.

**Measure:** Family Caregiver Well-Being Using GAD-7 Scale

**Time Frame:** 8 weeks per participant

**Description:** Caregiver well being will be measured using the Personal Health Questionnaire Depression 8 Item Scale Scale (PHQ 8). The PHQ 8 measures depression scoring 0-3 points per item, with a total score range of 0-24, with the higher score meaning more depression.

**Measure:** Family Caregiver Well-Being using PHQ-8 Scale

**Time Frame:** 8 weeks per participant

**Description:** Caregiver well being will be measured using the Zarit Burden Interview. The Zarit Burden Interview measures burden scoring 0-4 points per item, with a total score range of 0-48, with the higher score meaning more burden.

**Measure:** Family Caregiver Well-Being Using Zarit Burden Interview

**Time Frame:** 8 weeks per participant

**Description:** Neuro patients well being will be measured using the Generalized Anxiety Disorder 7 Item Scale (GAD-7). The GAD-7 measures anxiety scoring 0-3 points per item, with a total score range 0-21,with a higher score meaning more anxiety.

**Measure:** Neuro Patients Well-Being Using GAD-7 Scale

**Time Frame:** 8 weeks per participant

**Description:** Neuro patients well being will be measured using the Personal Health Questionnaire Depression 8 Item Scale Scale (PHQ 8). The PHQ 8 measures depression scoring 0-3 points per item, with a total score range of 0-24, with the higher score meaning more depression.

**Measure:** Neuro Patients Well-Being using PHQ-8 Scale

**Time Frame:** 8 weeks per participant

**Description:** Neuro patients well being will be measured using Neuro-Qol (Neuro Quality of Life) which will be using T scores where the lower values represent worse outcomes.

**Measure:** Neuro Patients Well-Being using NeuroQol

**Time Frame:** 8 weeks per participant

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* English-speaking/reading/writing
* Able to complete questionnaires (including by proxy)
* Family Caregivers (FCGs) must self-identify as being a primary FCG of a patient with a primary brain tumor, secondary (metastatic) brain tumor, or leptomeningeal disease diagnosis. A primary caregiver is a family member, friend, or other unpaid person who provides at least some care for a patient at home.
* Patients must be diagnosed with new or recurrent primary brain tumor, a secondary (metastatic) brain tumor or leptominingeal disease within the last 9 months, receiving at least some evaluation and/or care at Moffitt (i.e. at least one appointment), have a prognosis of at least 9 months

Exclusion Criteria:

* Patients may not participate without a consenting FCG, but FCGs may participate without a consenting patient
* Patients and FCGs who are experiencing acute distress will be excluded from enrollment and referred directly to social work, per Moffitt policy.

**Healthy Volunteers:** True

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Deanna.Witte@moffitt.org

**Name:** Deanna Witte

**Phone:** 813-745-2875

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tampa

**Contacts:**

***Contact 1:***

- **Email:** Margaret.Byrne@moffitt.org

- **Name:** Margaret Byrne, PhD

- **Phone:** 813-745-5569

- **Role:** CONTACT

***Contact 2:***

- **Name:** Margaret Byrne, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Peter Forsyth, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Moffitt Cancer Center

**State:** Florida

**Status:** RECRUITING

**Zip:** 33612

#### Overall Officials

**Official 1:**

**Affiliation:** Moffitt Cancer Center

**Name:** Margaret Byrne, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Reblin M, Ketcher D, McCormick R, Barrios-Monroy V, Sutton SK, Zebrack B, Wells KJ, Sahebjam S, Forsyth P, Byrne MM. A randomized wait-list controlled trial of a social support intervention for caregivers of patients with primary malignant brain tumor. BMC Health Serv Res. 2021 Apr 17;21(1):360. doi: 10.1186/s12913-021-06372-w.

**PMID:** 33865382

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000016543

- Term: Central Nervous System Neoplasms

- ID: D000009423

- Term: Nervous System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5209

- Name: Brain Neoplasms

- Relevance: HIGH

- As Found: Brain Cancer

- ID: M18937

- Name: Central Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12367

- Name: Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001932

- Term: Brain Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
