Web-based Patient Reported Outcome Measurement Information System (PROMIS ) to Explore Burden and Stress in Cancer Caregivers (BaSiC2)

NCT01981538 | Completed

• 2 other identifiers: 99991400614-CC-N006
• Study Type: observational
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stress

Keywords

Web-Based Survey; Cancer Caregivers; Natural History

Outcome Measures

Primary Outcomes (1)

• feasibility of collecting web-based PROs,

  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.

  6 months

Secondary Outcomes (1)

• To explore differences among caregivers across cancer populations,

  6 months

Study Arms (1)

Adult informal caregivers

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Klagholz 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 DERIVED

Study Officials

• Lena Jumin Lee (Park), Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 11, 2013
• Study Start: November 7, 2013
• Primary Completion: July 15, 2016
• Study Completion: August 23, 2016
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

US (1)