Clinical trial NCT02427490: A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
Official title: A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Caregivers
Medical Oncology
Keywords: Palliative Care
Caregivers
Medical Oncology
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. Investigators involved in this mixed methods pilot study will collect and analyze both quantitative and qualitative data, which will subsequently inform a large-scale randomized clinical trial of the problem-solving intervention.

Detailed description: Palliative oncology providers are ideally situated to improve the cancer journey for the millions of family members and friends who are vital to the care of seriously ill patients. In recent decades, the primary setting for cancer care has shifted from the hospital inpatient unit to the outpatient clinic, leaving family caregivers responsible for providing the majority of patient care in the home, often with little support or preparation. The numerous stressors associated with family caregiving often give rise to caregiver anxiety, depression, fatigue, neglect of self-care and, for particularly strained caregivers, psychological symptoms that mirror those experienced by trauma survivors. In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. Specifically, the investigators aim to 1) examine the feasibility of the intervention relative to recruitment, randomization, retention, and fidelity to core intervention components; 2) investigate the impact of the intervention on family caregiver anxiety, depression, and quality of life; and 3) explore the benefits and challenges associated with the intervention from the perspective of participants. To accomplish these aims, investigators will recruit and randomly assign 82 family caregivers of cancer patients receiving outpatient palliative care into two groups (usual care and intervention) and collect quantitative and qualitative data, which will be analyzed to inform a future large-scale randomized clinical trial of the problem-solving intervention.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* access to an Internet-connected device that will support videoconferencing software

Exclusion Criteria:

* Younger than 18 years of age,
* lack of access to an Internet-connected device that will support videoconferencing software

Primary outcomes:
measure: Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7)
timeFrame: Upon study enrollment, two weeks, four weeks, eight weeks
Secondary outcomes:
measure: Change in depression (as measured by the Patient Health Questionnaire - 9)
timeFrame: Upon study enrollment, two weeks, four weeks, eight weeks
measure: Change in problem-solving approach (as measured by the Problem-Solving Inventory)
timeFrame: Upon study enrollment, two weeks, four weeks, eight weeks
measure: Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised)
timeFrame: Upon study enrollment, two weeks, four weeks, eight weeks
Other outcomes:
measure: Change in caregiving problems and intensity
timeFrame: Upon study enrollment, two weeks, four weeks, eight weeks
Locations:
city: Columbia
country: United States
facility: University of Missouri Ambulatory Palliative Care Clinic
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Karla Washington, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Washington KT, Benson JJ, Chakurian DE, Popejoy LL, Demiris G, Rolbiecki AJ, Oliver DP. Comfort Needs of Cancer Family Caregivers in Outpatient Palliative Care. J Hosp Palliat Nurs. 2021 Jun 1;23(3):221-228. doi: 10.1097/NJH.0000000000000744.
citation: Washington KT, Craig KW, Parker Oliver D, Ruggeri JS, Brunk SR, Goldstein AK, Demiris G. Family caregivers' perspectives on communication with cancer care providers. J Psychosoc Oncol. 2019 Nov-Dec;37(6):777-790. doi: 10.1080/07347332.2019.1624674. Epub 2019 Jun 16.