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Glioblastoma Psychosocial Support Program

Study Purpose

The goal of the study is to conduct a pilot test of the psychosocial support intervention with family caregivers and/or patients coping with glioblastoma.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

For patients:

Inclusion Criteria:

  • - Patients who self-report a diagnosis of glioblastoma.
  • - Age >18 years.
  • - English Speaking.

Exclusion Criteria:

  • - Lacks capacity for interview or is unable to provide informed consent.
  • - Visual or hearing impairments or severe behavioral problems that preclude participation.
  • - Too sick to participate.
For caregivers:

Inclusion Criteria:

  • - Age >18 years.
  • - English Speaking.

Exclusion Criteria:

  • - Lacks capacity for interview or is unable to provide informed consent.
  • - Visual or hearing impairments or severe behavioral problems that preclude participation.
- Too sick to participate

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06038604
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Duke University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Laura S. Porter, PhD
Principal Investigator Affiliation Duke University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

The specific aims of this study is to pilot test the psychosocial support program for patients with glioblastoma and/or their family caregivers. The investigators will recruit patient-caregiver dyads for the psychosocial support intervention; participants will have the choice whether to take part in the intervention as a dyad or individually given the variability of symptoms and progression of glioblastoma. The investigators will examine acceptability and feasibility of the intervention and examine whether participation in the program can help reduce distress and improve quality of life.

Arms & Interventions

Arms

Experimental: Psychosocial Support Intervention

The psychosocial support intervention includes components such as logistical and practical support and self-care, strategies to manage cognitive changes, as well as strategies for effective communication when coping with glioblastoma.

Interventions

Behavioral: - Psychosocial Support Intervention

Participants will receive six weekly 60-minute sessions conducted by videoconference.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Duke University Medical Center, Durham, North Carolina

Status

Recruiting

Address

Duke University Medical Center

Durham, North Carolina, 27710

Site Contact

Laura S. Porter, PhD

laura.porter@duke.edu

919-416-3436