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Brain CancerNCT03026699

Refining and Testing the Electronic Social Network Assessment Program (eSNAP)

An observational study of Brain Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Brain Cancer
What is being tested?
eSNAP and Questionnaires
How many people
62 participants
Where
1 siteUnited States
Study dates
5 May 2017to 17 Oct 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Does not meet the Inclusion Criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

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.

Read the detailed description

Former Aim 1: Refine eSNAP data-gathering and visualization prototypes based on evaluations of user experience, including usability, satisfaction and applicability. The refining process was completed at the University of Utah.

Aim 2: Test the feasibility of implementing eSNAP in a neuro-oncology clinical setting and collect preliminary effectiveness data of eSNAP on Family Caregiver outcomes, including quality of life and stress, and mediators (Family Caregiver social support utilization and burden). The feasibility process will take place at Moffitt Cancer Center.

This study will be a 2x2 longitudinal design. Caregivers of primary brain tumor patients will be compared to caregivers of patients with secondary brain tumors (brain metastases) to determine if there is something unique about the cancer-specific duties of primary versus secondary brain tumors that could impact the effectiveness of the eSNAP application. An intervention group will be compared to a control group for both types of caregivers. Participants will be randomized 2:1 for the intervention and control. All caregivers will be followed for 6 weeks and will be asked to complete questionnaires at 3 time points; caregivers in the intervention group will also be asked to use the eSNAP application at time 1, which will be available to them for the duration of the study.

Conditions
Brain Cancer
Being tested
eSNAP, Questionnaires
Keywords
Brain, Nervous system, Neuro-oncology, Caregivers, Cancer patient, Family caregivers, Brain tumors, Quality of life, Stress, Social support, Feasibility, Electronic Social Network Assessment Program (eSNAP)
Medical subject headings
Brain Neoplasms, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eSNAPBehavioural

    Also called Electronic Social Network Assessment Program

    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.

  • QuestionnairesBehavioural

    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.

Study groups in NCT03026699
Study groupRoleWhat they receive
Intervention - Primary Brain TumoreSNAP Intervention Plus Questionnaires: Family caregivers of primary brain tumor patients.
Receives: Behavioral: eSNAP; Behavioral: Questionnaires
Intervention - Secondary Brain TumoreSNAP Intervention Plus Questionnaires: Family caregivers of secondary brain tumor patients.
Receives: Behavioral: eSNAP; Behavioral: Questionnaires
Control - Primary Brain TumorQuestionnaires Only Control: Family caregivers of primary brain tumor patients.
Receives: Behavioral: Questionnaires
Control - Secondary Brain TumorQuestionnaires Only Control: Family caregivers of secondary brain tumor patients.
Receives: Behavioral: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Questionnaire Participation Among Participant Groups

    Feasibility 1: Recruitment rates per group.

    Measured: 6 weeks per participant

  2. Retention of Participants Among Participant Groups

    Feasibility 2: Retention rates per group.

    Measured: 6 weeks per participant

Secondary outcomes (4)

  1. Stress and Coping - Quality of Life Among Participant Groups

    Although not reaching adequate power to detect differences, planned analysis will allow investigators to estimate effect size of eSNAP at baseline as well as the effect of cancer type. (Power analysis conducted in G*Power for ANOVA using effect size 0.2 a=.05 for 3 groups for power of 0.80 requires a sample of 246.) ANOVA will be conducted to determine if groups vary on stress and quality of life at baseline. Growth-curve analysis will be used to identify potential preliminary differences in the eSNAP group over time.

    Measured: 6 weeks per participant

  2. Perceived Social Support - Quality of Life Among Participant Groups

    Chi square and generalized linear model (GLM) will be used to analyze utilization of support services differences.

    Measured: 6 weeks per participant

  3. Incidence of Clinic Disruption

    Incidence of clinic disruption per participant group.

    Measured: 6 weeks per participant

  4. Incidence of Problems with eSNAP implementation

    Chi square and generalized linear model (GLM) will be used to analyze trends in satisfaction or time spent on ecomapping/eSNAP.

    Measured: 6 weeks per participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2017 (estimated)
  2. Study start5 May 2017
  3. Primary completion17 Oct 2017
  4. Study completion17 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03026699
Sponsor's protocol ID
MCC-18378
Other IDs
R03CA201684-01
Status last verified
Dec 2020
First submitted
12 Jan 2017
Last updated
2 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29948397

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaire Participation Among Participant Groups (time frame: 6 weeks per participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03026699, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.

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