Palliative CareNCT02427490
A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
A study testing Problem-Solving Intervention and Unenhanced Monitoring in people with Palliative Care and Caregivers, run by University of Missouri-Columbia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Caregivers, Medical Oncology
- What is being tested?
- Problem-Solving Intervention and Unenhanced Monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 24 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- access to an Internet-connected device that will support videoconferencing software
Who cannot join
- Younger than 18 years of age,
- lack of access to an Internet-connected device that will support videoconferencing software
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Ambulatory Palliative Care Clinic
Columbia, Missouri, 65212
About this study
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.
Read the 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.
- Conditions
- Palliative Care, Caregivers, Medical Oncology
- Being tested
- Problem-Solving Intervention, Unenhanced Monitoring
- Keywords
- Palliative Care, Caregivers, Medical Oncology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving InterventionBehavioural
Also called Problem-Solving Intervention for Family Caregivers
The problem-solving approach that will be taught in the problem-solving intervention is based on the ADAPT model, which encourages participants to follow five steps when solving problems: focus on adopting a positive attitude to problem-solving, define the problem and set goals, generate a list of alternative solutions to the problem, predict consequences of the alternative solutions, and try implementing the most promising solution from among the list of alternatives. The problem-solving intervention will be delivered by a trained interventionist in three structured sessions using videoconferencing tools.
Unenhanced MonitoringOther
Also called Unenhanced Monitoring of Behavioral Health Outcomes
Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
| Study group | Role | What they receive |
|---|---|---|
| Unenhanced Monitoring | Active comparator | Family caregivers of cancer patients receiving outpatient palliative care will complete standardized questionnaires at the time of study enrollment and two, four, and eight weeks after study enrollment. Receives: Other: Unenhanced Monitoring |
| Problem-Solving Intervention | Experimental | Family caregivers of cancer patients receiving outpatient palliative care will use videoconferencing tools to participate in three problem-solving sessions with a member of the research team. Receives: Behavioral: Problem-Solving Intervention; Other: Unenhanced Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7)
Family caregivers indicate the frequency with which they experience seven different symptoms of anxiety (7 items); higher scores reflect higher anxiety severity.
Measured: Upon study enrollment, two weeks, four weeks, eight weeks
Secondary outcomes (3)
Change in depression (as measured by the Patient Health Questionnaire - 9)
Family caregivers indicate the frequency with which they experience nine different symptoms of depression (9 items); higher scores reflect higher depression severity.
Measured: Upon study enrollment, two weeks, four weeks, eight weeks
Change in problem-solving approach (as measured by the Problem-Solving Inventory)
Family caregivers indicate the extent to which different statements describing approaches to problem-solving apply to them (25 items).
Measured: Upon study enrollment, two weeks, four weeks, eight weeks
Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised)
Family caregivers complete four items rating their physical, emotional, social, and financial quality of life on a scale of 0-10.
Measured: Upon study enrollment, two weeks, four weeks, eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion29 Apr 2017
- Study completion24 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla Washington, University of Missouri-Columbia
- Investigators
- Karla Washington, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427490
- Sponsor's protocol ID
- 2002215
- Status last verified
- Oct 2021
- First submitted
- 17 Apr 2015
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Benson JJ, Washington KT, Landon OJ, Chakurian DE, Demiris G, Parker Oliver D. When Family Life Contributes to Cancer Caregiver Burden in Palliative Care. J Fam Nurs. 2023 Aug;29(3):275-287. doi: 10.1177/10748407231167545. Epub 2023 May 16.
PubMed 37190779Washington 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.
PubMed 33605647Washington 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.
PubMed 31204604
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
- ClinicalTrials.gov ID
- NCT02427490
- Acronym / sponsor ID
- 2002215
- Conditions
- Palliative Care, Caregivers, Medical Oncology
- Keywords
- Palliative Care, Caregivers, Medical Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 29 Apr 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unenhanced Monitoring | Active comparator | Other: Unenhanced MonitoringFamily caregivers of cancer patients receiving outpatient palliative care will complete standardized questionnaires at the time of study enrollment and two, four, and eight weeks after study enrollment. |
| Problem-Solving Intervention | Experimental | Behavioral: Problem-Solving Intervention, Other: Unenhanced MonitoringFamily caregivers of cancer patients receiving outpatient palliative care will use videoconferencing tools to participate in three problem-solving sessions with a member of the research team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older,
- access to an Internet-connected device that will support videoconferencing software
Key exclusion criteria (2 listed)
- Younger than 18 years of age,
- lack of access to an Internet-connected device that will support videoconferencing software
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem-Solving InterventionAlso: Problem-Solving Intervention for Family CaregiversThe problem-solving approach that will be taught in the problem-solving intervention is based on the ADAPT model, which encourages participants to follow five steps when solving problems: focus on adopting a positive attitude to problem-solving, define the problem and set goals, generate a list of alternative solutions to the problem, predict consequences of the alternative solutions, and try implementing the most promising solution from among the list of alternatives. The problem-solving intervention will be delivered by a trained interventionist in three structured sessions using videoconferencing tools. | Behavioural | Problem-Solving Intervention |
| Unenhanced MonitoringAlso: Unenhanced Monitoring of Behavioral Health OutcomesStudy participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment. | Other | Problem-Solving Intervention, Unenhanced Monitoring |
Primary outcome
Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7)
Time frame: Upon study enrollment, two weeks, four weeks, eight weeks
Family caregivers indicate the frequency with which they experience seven different symptoms of anxiety (7 items); higher scores reflect higher anxiety severity.
3 secondary outcomes
Change in depression (as measured by the Patient Health Questionnaire - 9)
Time frame: Upon study enrollment, two weeks, four weeks, eight weeks
Change in problem-solving approach (as measured by the Problem-Solving Inventory)
Time frame: Upon study enrollment, two weeks, four weeks, eight weeks
Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised)
Time frame: Upon study enrollment, two weeks, four weeks, eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Derived from this study: PubMed 37190779Benson JJ, Washington KT, Landon OJ, Chakurian DE, Demiris G, Parker Oliver D. When Family Life Contributes to Cancer Caregiver Burden in Palliative Care. J Fam Nurs. 2023 Aug;29(3):275-287. doi: 10.1177/10748407231167545. Epub 2023 May 16.
- Derived from this study: PubMed 33605647Washington 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.
- Derived from this study: PubMed 31204604Washington 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla Washington, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Intervention and Unenhanced Monitoring in people with Palliative Care and Caregivers, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7) (time frame: Upon study enrollment, two weeks, four weeks, eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427490, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.