Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
- - FCGs (e.g., spouse/partner, parent, adult child) of patients diagnosed with HGG receiving any form of cancer treatment (including palliative intent) at MDACC.
- - Patients must have a Karnofsky Performance Status (KPS) of 100 to 50.
- - Both FCGs and patients must be willing to participate and (1) ≥18 years old and able to (2) read and speak English and (3) provide informed consent.
- - FCGs who regularly participate in psychotherapy with a licensed professional (self-reported).
- - Patients with cognitive impairment that would impede ability to complete self-report surveys as documented in the medical record.
- - Children under the age of 18 will not be included in this trial.
- - Childhood brain tumors tend to be diagnosed in infancy and the caregiving and symptom management needs are vastly different than in the adult patient population.
- - While pregnant caregivers (self-reported) are study eligible, we will also exclude pregnant patients (medical notes).
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|M.D. Anderson Cancer Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Kathryn Milbury, MA,PHD|
|Principal Investigator Affiliation||M.D. Anderson Cancer Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Trial 1 (single-arm study) • Aim 1: Examine the usability of the intervention content and trial assessments in 10 caregiver-patient dyads to refine study procedures as needed. Trial 2 (RCT) Aim 1 (primary aim): Determine the feasibility of implementing a caregiving intervention using a randomized controlled design in 50 caregiver-HGG patient dyads. Aim 2: Evaluate the initial evidence for intervention efficacy relative to a WLC group regarding patient and caregiver psychological symptoms (primary outcome), caregiver caregiving efficacy and role adjustment, and patient cancer-related symptoms and healthcare utilization (secondary outcomes). Aim 3: Understand caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research.
Other: Baseline Assessment
Participants will be asked to complete a baseline assessment of questionnaires that will ask: Demographic information (such as your age, sex, and race) Psychological and physical health
Other: Caregiver Intervention Sessions
Caregiver will take part in 4 caregiver intervention sessions. The first 2 sessions will take place in the Simulation Center at the hospital when you are scheduled for treatment or a follow-up appointment. The remaining 2 sessions will be done remotely using a videoconference platform (such as Zoom) and will focus on discussing your caregiver's role and experiences and suggesting coping and self-care strategies.
Behavioral: - Questionnaires
Participants will be asked to complete this assessment on your own time, and it should take about 40 minutes.
Behavioral: - Caregiver Assessment
These sessions will involve simulation-based, caregiving skill training, and your caregiver will be taught skills to help support you (such as feeding, hygiene, mobility, medication administration, and care coordination).
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.