Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01981538 |
| Other study ID # |
999914006 |
| Secondary ID |
14-CC-N006 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 7, 2013 |
| Est. completion date |
August 23, 2016 |
Study information
| Verified date |
June 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
An estimated 65.7 million adults in America provide unpaid care to an individual who is
disabled or ill; 7% (an estimated 4.6 million) are caring for a cancer patient. A body of
evidence is accumulating that suggests the burden of caring for a family member across a
variety of cancer populations can be extremely stressful. The stress of caregiving can have
physical and psychological repercussions that can ultimately lead to increased morbidity and
mortality. Spousal caregivers of hospitalized individuals are at increased risk of dying
within a year of an acute hospitalization, and this risk appears to vary based upon
diagnosis. While some evidence suggests caregivers may place the patient s needs above their
own and neglect their own health in the process, the evidence regarding whether the stress of
caregiving is associated with unhealthy behaviors such as excessive use of alcohol or
increased use of tobacco is unclear.
While the evidence clearly shows that caregiving is stressful and may be deleterious to one s
health, caregivers are not typically screened for physical and psychological health issues.
Most research regarding the stress of caregiving has focused on psychological outcomes
including caregiver burden and most research was conducted primarily during the survivorship
phase (treatment complete). Because no large studies have examined burden and health outcomes
in caregivers over time and across cancer diagnoses during and after the active treatment
period, the primary purpose of this study is to assess the feasibility of collecting
web-based patient-reported outcomes (PROs) from unpaid informal caregivers of cancer patients
that examine the relationships between psychological, health behaviors and health outcomes
over time during the active treatment period. A number of secondary objectives will also be
addressed including: to explore differences among caregivers across cancer populations and
caregiver categories (for example, spousal caregivers versus parent or child caregivers;
single caregivers versus multiple caregivers), and to examine whether healthy behaviors
ameliorate the relationship between burden and health outcomes. By using a large variety of
measures and including a sample of caregivers from multiple cancer patient populations, we
hope to identify those populations most at risk as well as those areas (health outcomes and
behaviors) where caregivers might be most at risk for negative outcomes.
Subjects will be eligible for this protocol if they are adult informal caregivers to a
patient enrolled in a cancer treatment study at the NIH Clinical Center. Once informed
consent is obtained, the participant will be provided with information to access the PROMIS
assessment center to complete the secure web-based survey. Subjects will complete
questionnaires collecting information about caregiver burden and health outcomes at three
time points 1) Enrollment, which will coincide with start of treatment for cancer, 2) 3
months after Enrollment, and 3) 6 months after Enrollment. An optionoal "Off-Study"
questionnaire completion time point would be offered in the event that the caregiver or the
study team requests removal from study participation before the final time point.
Questionnaires will capture psychological and behavioral outcomes including: Caregiver
Reaction Assessment, NIH Toolbox measures on Loneliness, Self-Efficacy, Meaning & Purpose,
and Perceived Stress, Family Caregiver Inventory Mutuality, Spiritual Perspective Scale,
Health-Promoting Lifestyle Profile-II, and PROMIS measures for Global Health, Anxiety,
Depression, Sleep Disturbance, Fatigue, and Applied Cognition. A clinician interview will
assess basic demographic, health issues, use of alcohol and tobacco and the impact of
caregiving at each time point. A brief exit interview will be conducted at the conclusion of
participation; there will be no long term follow-up after the study participation period.
Exploratory, hypothesis-generating analyses will be performed using parametric and
non-parametric statistical techniques.
