Head and Neck CancerNCT02577237
Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer
A study testing In-person education sessions, NCI Booklet and Survey in people with Head and Neck Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Patients with head and neck cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- In-person education sessions, NCI Booklet and Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 12 Jan 2018
- 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
- family member or friend of an adult patient with a new diagnosis of Stage III - IV cancers of the tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, or parotid who is receiving radiation therapy for curative intent
- identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support
- cognitively intact, as evidenced by orientation to person, place, and time
- ability to speak, read, and comprehend English
Who cannot join
- Caregivers of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care
- Caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer
Patients with head and neck cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study tests whether different forms of education and support can help family caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, this study wants to compare approaches.One group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses. The other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses. The caregiver also completes surveys about his or her emotions, distress, confidence as a care giver, and quality of life. In addition, the study asks the caregiver questions about his or her age, race, ethnicity, marital status, employment status, education, annual household income, and current living arrangements. This pilot study will only be offered at the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Main Campus.
Read the detailed description
Aim 1: Conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life.
Aim 2: Explore the acceptability of a caregiver intervention that utilizes simulation.
Aim 3: Assess the feasibility of the intervention. Aim 4: Describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.
- Conditions
- Head and Neck Cancer
- Being tested
- In-person education sessions, NCI Booklet, Survey, Interview
- Keywords
- caregiver, simulation
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person education sessionsBehavioural
Also called intervention group, educational content/simulation
The intervention will be delivered by a radiation oncology nurse. Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing.
NCI BookletBehavioural
Also called When Someone You Love is being Treated for Cancer
Radiation Oncology Nurse will hand participant the NCI booklet
SurveyOther
written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
InterviewOther
Also called semi-structured interview, Open ended questions
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Caregiver education | Experimental | The intervention includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses. Receives: Behavioral: In-person education sessions; Other: Survey; Other: Interview |
| Control Group: educational booklet | Active comparator | The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses Receives: Behavioral: NCI Booklet; Other: Survey; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average efficacy of caregiving summary score
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Measured: Up to 5 weeks
Average anxiety summary score
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Measured: Up to 5 weeks
Average depression summary score
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Measured: Up to 5 weeks
Average Health Related Quality of Life (HRQOL) summary score
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Measured: Up to 5 weeks
Secondary outcomes (6)
Qualitative assessment of acceptability
Descriptive statistics will be used to summarize responses to semi-structured interviews
Measured: Up to 5 weeks
Attrition rate to assess feasibility
Feasibility will be assessed via attrition and consent rates.
Measured: Up to 5 weeks
Consent rate to assess feasibility
Feasibility will be assessed via attrition and consent rates.
Measured: Up to 5 weeks
Total time for delivering intervention to assess costs
Time for delivering the intervention will be recorded to aid in assessing costs.
Measured: Up to 5 weeks
Average missed checklist items to assess integrity of intervention
Integrity of the intervention will be assessed through monitoring of intervention checklist.
Measured: Up to 5 weeks
Event rate for patient events
Describe the average incidence of all patient events that may be impacted by caregiver self-efficacy. Events may include acute care visits, admission to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course, and others
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start1 Aug 2015
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Mazanec, PhD, RN, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577237
- Sponsor's protocol ID
- CASE2315
- Status last verified
- Feb 2019
- First submitted
- 14 Oct 2015
- Last updated
- 11 Feb 2019
- 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 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT02577237
- Acronym / sponsor ID
- CASE2315
- Conditions
- Head and Neck Cancer
- Keywords
- caregiver, simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 16 Oct 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.
Patients with head and neck cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study tests whether different forms of education and support can help family caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, this study wants to compare approaches.One group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses. The other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses. The caregiver also completes surveys about his or her emotions, distress, confidence as a care giver, and quality of life. In addition, the study asks the caregiver questions about his or her age, race, ethnicity, marital status, employment status, education, annual household income, and current living arrangements. This pilot study will only be offered at the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Main Campus.
Detailed description
Aim 1: Conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life.
Aim 2: Explore the acceptability of a caregiver intervention that utilizes simulation.
Aim 3: Assess the feasibility of the intervention. Aim 4: Describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Caregiver education | Experimental | Behavioral: In-person education sessions, Other: Survey, Other: InterviewThe intervention includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses. |
| Control Group: educational booklet | Active comparator | Behavioral: NCI Booklet, Other: Survey, Other: InterviewThe control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- family member or friend of an adult patient with a new diagnosis of Stage III - IV cancers of the tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, or parotid who is receiving radiation therapy for curative intent
- identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support
- cognitively intact, as evidenced by orientation to person, place, and time
- ability to speak, read, and comprehend English
Key exclusion criteria (2 listed)
- Caregivers of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care
- Caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)
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 |
|---|---|---|
| In-person education sessionsAlso: intervention group, educational content/simulationThe intervention will be delivered by a radiation oncology nurse. Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing. | Behavioural | Intervention Group: Caregiver education |
| NCI BookletAlso: When Someone You Love is being Treated for CancerRadiation Oncology Nurse will hand participant the NCI booklet | Behavioural | Control Group: educational booklet |
| Surveywritten, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history. | Other | Control Group: educational booklet, Intervention Group: Caregiver education |
| InterviewAlso: semi-structured interview, Open ended questionsA structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment. | Other | Control Group: educational booklet, Intervention Group: Caregiver education |
Primary outcome
Average efficacy of caregiving summary score
Time frame: Up to 5 weeks
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Average anxiety summary score
Time frame: Up to 5 weeks
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Average depression summary score
Time frame: Up to 5 weeks
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
Average Health Related Quality of Life (HRQOL) summary score
Time frame: Up to 5 weeks
Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.
6 secondary outcomes
Qualitative assessment of acceptability
Time frame: Up to 5 weeks
Attrition rate to assess feasibility
Time frame: Up to 5 weeks
Consent rate to assess feasibility
Time frame: Up to 5 weeks
Total time for delivering intervention to assess costs
Time frame: Up to 5 weeks
Average missed checklist items to assess integrity of intervention
Time frame: Up to 5 weeks
Event rate for patient events
Time frame: Up to 5 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 11 Feb 2019.
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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.
Susan Mazanec, PhD, RN principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person education sessions, NCI Booklet and Survey in people with Head and Neck Cancer, run by Case Comprehensive 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 4 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 11 Feb 2019. 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?
Average efficacy of caregiving summary score (time frame: Up to 5 weeks). The study lists 4 primary outcomes in all. 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 11 Feb 2019.