Advanced Malignant NeoplasmNCT04186884
Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
An observational study of Advanced Malignant Neoplasm and Locally Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies caregiver burden, quality of life, and symptom distress of patients and their informal (unpaid) caregivers at different palliative care settings. Cancer caregiving may affect a caregiver's life physically, emotionally, socially, and financially. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm
- What is being tested?
- Quality-of-Life Assessment and Questionnaire Administration
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2019to 5 Nov 2021
- Phase
- Observational
- 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
Study population: Patients visiting the SCC for a first consultation or patients admitted to the PCU at MD Anderson Cancer Center and primary informal caregiver of patient
Who may be able to join
- ( SCC Patient) Patients visiting the SCC for a first consultation.
- (SCC Patient) Patients who can identify a primary informal caregiver.
- (SCC Patient) Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
- (SCC Patient) Be able to read and speak English.
- (SCC Patient) 18 years of age or older.
- (Caregiver of SCC Patient) Be identified or self-identified as a primary informal caregiver of the patient. The caregiver could be present or verbally agree to participate.
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- (Caregiver of SCC Patient) Be able to read and speak English.
- (Caregiver of SCC Patient) 18 years of age or older.
- (Caregiver of SCC Patient) Caregivers who are not able to complete the assessment on the day of patients' first consultation must be willing to engage in a telephone assessment with research staff +/- 3 days after.
- (PCU Patient) Patients who have been admitted to the PCU at MD Anderson Cancer Center.
- (PCU Patient) Patients should have a primary informal caregiver during their PCU stay.
- (PCU Patient) Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
- (PCU Patient) Be able to read and speak English.
- (PCU Patient) 18 years of age or older.
- (Caregiver of PCU Patient) Be identified by the patient or self-identified as the primary informal caregiver of the patient. The caregiver should be present with the patient during PCU stay.
- (Caregiver of PCU Patient) Be able to read and speak English.
- (Caregiver of PCU Patient) 18 years of age or older.
Who cannot join
- (SCC Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (SCC Patient) Patients with only paid caregivers.
- (SCC Patient) Patients with cognitive impairment as identified by research staff, treating physician or nurse.
- (Caregiver of SCC Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (Caregiver of SCC Patient) Patients with no caregivers or patients with only paid caregivers.
- (PCU Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
Show all 10Show fewer
- (PCU Patient) Patients with no caregivers or patients with only paid caregivers.
- (PCU Patient) Patients with cognitive impairment as identified by research staff, treating physician or nurse.
- (Caregiver of PCU Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (Caregiver of PCU Patient) Patients with no caregivers or patients with only paid caregivers.
Trial locations and contacts
1 site in 1 country.
About this study
This trial studies caregiver burden, quality of life, and symptom distress of patients and their informal (unpaid) caregivers at different palliative care settings. Cancer caregiving may affect a caregiver's life physically, emotionally, socially, and financially. Studying caregiver burden may help investigators learn about caregivers' opinions on stress of caregiving, and about the factors related to caregiver burdens.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the severity of subjective stress burden (emotional impact) between caregivers of patients seen at the Supportive Care Center (SCC) and those seen at the Palliative Care Unit (PCU) as measured by the Montgomery - Borgatta Caregiver Burden Scale.
SECONDARY OBJECTIVES:
- To compare objective burden (impact on tangible aspects of life) between caregivers of patients seen at SCC and the PCU.
II. To compare subjective demand burden (impact on the patient-caregiver relationship) between caregivers of patients seen at the SCC and the PCU.
III. To compare caregiver quality of life (measured by the Short-form 36) and symptom distress (measured by the caregiver ESAS [Edmonton Symptom Assessment System]) between caregivers of patients seen at the SCC and the PCU.
IV. To examine if there is a correlation between caregiver burden (Montgomery-Borgatta scale), quality of life (Short-form 36 scale) and symptom distress (ESAS caregiver scale).
- To determine which caregiver and/or patients' factors are associated with caregiver burden, quality of life, and symptom distress.
OUTLINE:
Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.
- Conditions
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Observational (questionnaires) | Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of subjective stress burden (emotional impact) in caregivers of patients seen at the Supportive Care Center (SCC) and at the Palliative Care Unit (PCU)
Measured by the Montgomery-Borgatta Caregiver Burden Scale. (4-item sub-scale questionnaire to measure the degree caregivers perceive their tasks and evaluates emotional effects of caregiving has a (Cronbach Alpha ranging from 0.68 to 0.82.)
Measured: Day 1, day of enrollment
Secondary outcomes (5)
Objective burden (impact on tangible aspects of life Questionnaire
Measured by Montgomery-Borgatta Caregiver Burden Scale using the 6-item objective burden sub-scale questionnaire. The sub-scale measure objective effects of caregiving in the caregivers life (i.e.:amount of time for personal privacy, recreational activities, time available to work, etc.) has a. Cronbach Alpha ranging from 0.87 to 0.90
Measured: Day 1, day of enrollment
Subjective demand burden (impact on the patient-caregiver relationship) of caregivers
Measured by Montgomery-Borgatta Caregiver Burden Scale using the 4-item subjective demand burden sub-scale questionnaire. (ranges from 0.81 to 0.88)
Measured: Day 1, day of enrollment
Caregiver quality of life and symptoms of distress
Will compare caregiver quality of life (measured by the Short-form 36) and caregiver symptom distress (measured by the caregiver Edmonton Symptom Assessment System [ESAS]) between caregivers of patients seen at the SCC and the PCU between caregivers of patients seen at the SCC and the PCU.(Cronbach Alpha ranges from 0.70 to 0.94)
Measured: Day 1, day of enrollment
Caregiver symptom distress
Will examine the correlation between caregiver burden (Montgomery-Borgatta scale), quality of life (Short-form 36 scale) and symptom distress (ESAS caregiver scale). Explore if caregivers with higher burden will also have worse quality of life and higher symptom distress
Measured: Day 1, day of enrollment
Factors that are associated with caregiver burden, quality of life, and symptom distress Questionnaires
Explore the effect of patients'caregivers' demographics, comorbidities (Charlson Comorbidity Index), duration of care since diagnosis, strength of religious faith and engagement (Santa Clara Strength of Religious Faith Questionnaire), trust in medical profession (Trust in the Medical Profession Questionnaire with caregiver burden, quality of life, patients' demographics and/or symptom distress, clinical characteristics (comorbidities, performance status, symptom distress scores, delirium severity prognosis) on each of caregivers' burden, quality of life, and symptom distress. Responses are summed and scores range from 5-25, with higher scores indicating higher trust
Measured: Day 1, day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start26 Mar 2019
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberson C Tanco, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186884
- Sponsor's protocol ID
- 2018-0819
- Other IDs
- NCI-2019-01197, 2018-0819, P30CA016672
- Status last verified
- Mar 2022
- First submitted
- 28 Mar 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Burden, Quality of Life, and Symptom Distress at Different Palliative Cancer Care Settings
- ClinicalTrials.gov ID
- NCT04186884
- Acronym / sponsor ID
- 2018-0819
- Conditions
- Advanced Malignant Neoplasm, Locally Advanced Malignant Neoplasm, Metastatic Malignant Neoplasm, Recurrent Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 5 Dec 2019 (actual)
- 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.
This trial studies caregiver burden, quality of life, and symptom distress of patients and their informal (unpaid) caregivers at different palliative care settings. Cancer caregiving may affect a caregiver's life physically, emotionally, socially, and financially. Studying caregiver burden may help investigators learn about caregivers' opinions on stress of caregiving, and about the factors related to caregiver burdens.
Detailed description
PRIMARY OBJECTIVE:
- To compare the severity of subjective stress burden (emotional impact) between caregivers of patients seen at the Supportive Care Center (SCC) and those seen at the Palliative Care Unit (PCU) as measured by the Montgomery - Borgatta Caregiver Burden Scale.
SECONDARY OBJECTIVES:
- To compare objective burden (impact on tangible aspects of life) between caregivers of patients seen at SCC and the PCU.
II. To compare subjective demand burden (impact on the patient-caregiver relationship) between caregivers of patients seen at the SCC and the PCU.
III. To compare caregiver quality of life (measured by the Short-form 36) and symptom distress (measured by the caregiver ESAS [Edmonton Symptom Assessment System]) between caregivers of patients seen at the SCC and the PCU.
IV. To examine if there is a correlation between caregiver burden (Montgomery-Borgatta scale), quality of life (Short-form 36 scale) and symptom distress (ESAS caregiver scale).
- To determine which caregiver and/or patients' factors are associated with caregiver burden, quality of life, and symptom distress.
OUTLINE:
Patients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (questionnaires) | – | Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients and caregivers visiting SCC for a consult or admitted to PCU complete questionnaires over 35 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the SCC for a first consultation or patients admitted to the PCU at MD Anderson Cancer Center and primary informal caregiver of patient
Key inclusion criteria (17 listed)
- ( SCC Patient) Patients visiting the SCC for a first consultation.
- (SCC Patient) Patients who can identify a primary informal caregiver.
- (SCC Patient) Diagnosis of advanced cancer defined as locally advanced, recurrent, or metastatic.
- (SCC Patient) Be able to read and speak English.
- (SCC Patient) 18 years of age or older.
Key exclusion criteria (10 listed)
- (SCC Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (SCC Patient) Patients with only paid caregivers.
- (SCC Patient) Patients with cognitive impairment as identified by research staff, treating physician or nurse.
- (Caregiver of SCC Patient) Refusal to participate in this study. This study requires both patient and caregiver enrollment.
- (Caregiver of SCC Patient) Patients with no caregivers or patients with only paid caregivers.
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (questionnaires) |
Primary outcome
Severity of subjective stress burden (emotional impact) in caregivers of patients seen at the Supportive Care Center (SCC) and at the Palliative Care Unit (PCU)
Time frame: Day 1, day of enrollment
Measured by the Montgomery-Borgatta Caregiver Burden Scale. (4-item sub-scale questionnaire to measure the degree caregivers perceive their tasks and evaluates emotional effects of caregiving has a (Cronbach Alpha ranging from 0.68 to 0.82.)
5 secondary outcomes
Objective burden (impact on tangible aspects of life Questionnaire
Time frame: Day 1, day of enrollment
Subjective demand burden (impact on the patient-caregiver relationship) of caregivers
Time frame: Day 1, day of enrollment
Caregiver quality of life and symptoms of distress
Time frame: Day 1, day of enrollment
Caregiver symptom distress
Time frame: Day 1, day of enrollment
Factors that are associated with caregiver burden, quality of life, and symptom distress Questionnaires
Time frame: Day 1, day of enrollment
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 3 Mar 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Kimberson C Tanco principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Malignant Neoplasm and Locally Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center 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 17 inclusion and 10 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 3 Mar 2022. 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?
Severity of subjective stress burden (emotional impact) in caregivers of patients seen at the Supportive Care Center (SCC) and at the Palliative Care Unit (PCU) (time frame: Day 1, day of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2022.