Clinical trial · Observational
Web-based Patient Reported Outcome Measurement Information System (PROMIS ) to Explore Burden and Stress in Cancer Caregivers (BaSiC2)
Web-Based Patient Reported Outcome Measurement Information System to Explore Burden, and Stress in Cancer Caregivers (BaSiC2)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: \- Caring for a loved one is often stressful. Some studies show it may affect health and emotions. Researchers want to know more about this but do not know the best way to gather data. They want to know if an online survey is a good way to gather data from caregivers of people receiving cancer treatment at the NIH Clinical Center. They want to know if there are differences among caregivers depending on the type of cancer treatment the family member or friend is receiving. They want to use this data to improve support programs for caregivers. Objectives: \- To see if an online study is a good way to get data from caregivers of people with cancer. Eligibility: \- Adults 18 years old and older who are taking care of a cancer patient at the NIHCC. Design: * The study period begins when the family member or friend begins a new cancer treatment and continues for 6 months afterward. * Participants will complete an online survey 3-4 times. This will include questions about caregiving, stress, emotions, and spirituality. The survey can be taken anywhere on a computer. It will take about 30 45 minutes each time. * Participants will also answer general questions about themselves and their health. This will be done over the phone with the study team. It will take 5 minutes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stress | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Adult informal caregivers
- description
- Subjects will be eligible for this protocol if they are adult informal caregivers that are family members or friends of a patient enrolled in a cancer treatment study at the NIH Clinical Center
Primary outcomes (1)
- measure
- feasibility of collecting web-based PROs,
- timeFrame
- 6 months
- description
- To examine the feasibility of collecting web-based patient-reported outcomes (PROs) over time in unpaid informal caregivers of cancer patients during the active treatment period.
Secondary outcomes (1)
- measure
- To explore differences among caregivers across cancer populations,
- timeFrame
- 6 months
- description
- To explore differences among caregivers across cancer populations, caregiver categories (for example, spousal caregivers versus parent or child caregivers; single caregivers versus multiple caregivers), and across different points in time.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Age greater than or equal to 18 years old * Ability to comprehend the investigational nature of the study * Able to read and speak English or Spanish * Agrees to participate in the study * Intends to serve as an active caregiver\* for a patient undergoing cancer treatment at the NIH Clinical Center (inpatient, outpatient or in the day hospital) * Internet access and the ability to complete online surveys (other than on a Smartphone) * If more than one caregiver is planned during the treatment phase, all caregivers will be invited to participate in the study. An active caregiver is defined as someone who reports regularly providing care to the cancer patient. EXCLUSION CRITERIA:\<TAB\> * Age less than or equal to 18 years old * Inability to comprehend investigational nature of study * Inability to provide informed consent * Unable to read and speak English or Spanish * Does not agree to participate in study or follow study design * Serving as a paid caregiver for the NIH Clinical Center treatment recipient * No computer or internet access (other than a Smartphone) * Refusal to complete online surveys All excluded subjects will be tracked by the study team including the reasons they were not eligible to enroll in the study for reporting to the IRB and to determine the incidence and prevalence computer and internet access issues that limit participation.
References
Publications (1)
- DERIVEDKlagholz SD, Ross A, Wehrlen L, Bedoya SZ, Wiener L, Bevans MF. Assessing the feasibility of an electronic patient-reported outcome (ePRO) collection system in caregivers of cancer patients. Psychooncology. 2018 Apr;27(4):1350-1352. doi: 10.1002/pon.4658. Epub 2018 Mar 5. No abstract available. PMID 29405538