NCT03026699

Brief Summary

The purpose of the study is to learn more about neuro-oncology caregivers' quality of life and how friends and families help neuro-oncology cancer caregivers at different times during treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 5, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

6 months

First QC Date

January 12, 2017

Last Update Submit

December 1, 2020

Conditions

Brain Cancer

Keywords

BrainNervous systemNeuro-oncologyCaregiversCancer patientFamily caregiversBrain tumorsQuality of lifeStressSocial supportFeasibilityElectronic Social Network Assessment Program (eSNAP)

Outcome Measures

Primary Outcomes (2)

  • Questionnaire Participation Among Participant Groups

    Feasibility 1: Recruitment rates per group.

    6 weeks per participant

  • Retention of Participants Among Participant Groups

    Feasibility 2: Retention rates per group.

    6 weeks per participant

Secondary Outcomes (4)

  • Stress and Coping - Quality of Life Among Participant Groups

    6 weeks per participant

  • Perceived Social Support - Quality of Life Among Participant Groups

    6 weeks per participant

  • Incidence of Clinic Disruption

    6 weeks per participant

  • Incidence of Problems with eSNAP implementation

    6 weeks per participant

Study Arms (4)

Intervention - Primary Brain Tumor

eSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients.

Behavioral: eSNAPBehavioral: Questionnaires

Intervention - Secondary Brain Tumor

eSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients.

Behavioral: eSNAPBehavioral: Questionnaires

Control - Primary Brain Tumor

Questionnaires Only Control: Family caregivers of primary brain tumor patients.

Behavioral: Questionnaires

Control - Secondary Brain Tumor

Questionnaires Only Control: Family caregivers of secondary brain tumor patients.

Behavioral: Questionnaires

Interventions

eSNAPBEHAVIORAL

Participants in the intervention group will then be given a tablet loaded with the eSNAP application and asked to create a visualization of their social networks. Upon completion, participants will be asked to review their ecomaps and complete the user experience questionnaire.

Also known as: Electronic Social Network Assessment Program
Intervention - Primary Brain TumorIntervention - Secondary Brain Tumor
QuestionnairesBEHAVIORAL

Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.

Control - Primary Brain TumorControl - Secondary Brain TumorIntervention - Primary Brain TumorIntervention - Secondary Brain Tumor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be family caregivers recruited from the Moffitt Cancer Center Radiation Oncology Clinic.

You may qualify if:

  • Family caregiver of a patient with primary or secondary brain tumor
  • Age 18 years or older
  • Able to speak and write English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • Reblin M, Ketcher D, Forsyth P, Mendivil E, Kane L, Pok J, Meyer M, Wu YP, Agutter J. Feasibility of implementing an electronic social support and resource visualization tool for caregivers in a neuro-oncology clinic. Support Care Cancer. 2018 Dec;26(12):4199-4206. doi: 10.1007/s00520-018-4293-z. Epub 2018 Jun 12.

    PMID: 29948397DERIVED

Related Links

MeSH Terms

Conditions

Brain NeoplasmsNeurologic Manifestations

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Maija Reblin, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 20, 2017

Study Start

May 5, 2017

Primary Completion

October 17, 2017

Study Completion

October 17, 2017

Last Updated

December 2, 2020

Record last verified: 2020-12

Locations

US(1)