Caregiver AnxietyNCT04639700
Intervention for Caregivers of Patients Who Have Recently Undergone HSCT
A study testing Psycho-educational intervention in people with Caregiver Anxiety and Caregiver Distress, run by Case Comprehensive Cancer Center.
Trial summary
The purpose of this study is to find out if providing support to caregivers of patients who have recently had a HSCT is possible and helpful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Anxiety, Caregiver Distress, Caregiver Health Related QOL
- What is being tested?
- Psycho-educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Nov 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An adult family or friend of a patient who has been discharged from the hospital in the past 1-2 weeks after receiving HSCT
- Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT
- Has English as their primary language
Who cannot join
- -Not meeting inclusion criteria
About this study
Official title: A Pilot Study to Evaluate the Feasibility of an Intervention for Caregivers of Patients Who Have Recently Undergone HSCT
The purpose of this study is to find out if providing support to caregivers of patients who have recently had a HSCT is possible and helpful.
Read the detailed description
This study will test the feasibility, acceptability, usability, satisfaction and preliminary efficacy of a behavioral (psychoeducation) intervention. All participants will receive the standard post-hospital HSCT information for patient follow-up care as provided by the patient's oncologist. In addition, the all participants will receive 4 individual sessions with an interventionist.
- Being tested
- Psycho-educational intervention
- Keywords
- Hematopoietic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-educational interventionBehavioural
Participant will be sent a baseline survey, and will then be contacted by the interventionist to complete 4 sessions, which feature the following areas:
Session 1: Identifying CG Needs for Information \& Support, Communication with Healthcare Team
Session 2: Communication with Patient and Family
Session 3: Self-care: Emotional \& Spiritual Needs, Self-care: Physical Needs
Session 4: Re-Assessing Needs, Planning for the future
| Study group | Role | What they receive |
|---|---|---|
| Psycho-educational intervention | Experimental | All participants will receive receive 4 individual sessions with an interventionist in addition to the standard post-hospital HSCT information for patient follow-up care as provided by the patient's oncologist Receives: Behavioral: Psycho-educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability Scale scores
Caregiver Acceptability as measured by Acceptability Scale scores. Overall score ranging from 6-30. According to prior research, a score of 80% of higher (total score of 24 or higher) is considered acceptable for use.
Measured: At 2 months
System Usability Scale scores
Caregiver Usability as measured by the System Usability Scale. This is a 10 item scale scored on a 5 point Likert scale with total summed scores ranging from 0-50. Total scores are multiplied by 2 to produce an overall score ranging from 0-100 with scores > 68 considered to be above average usability
Measured: At 2 months
Mean caregiver satisfaction scores
Caregiver Satisfaction scores as measured by Likert Scale. After completing each module, they will be sent via REDCap a single item evaluation scale (0 -10; 0=Not at all satisfied; 10=Highly satisfied). Scores >7 will be considered acceptable. Mean and standard deviation will be reported.
Measured: At the end of each intervention session and end of study evaluation, up to 2 months
Percent of enrollment of eligible participants
Feasibility as measured by percent of enrollment of eligible participants
Measured: At 2 months
Percent of participants completing intervention
Feasibility as measured by intervention completion
Measured: At 2 months
Retention rate
Feasibility as measured by percent of participants retained in full study (aim: 90% retention at the end of the 2-month intervention)
Measured: At 2 months
Average time to recruit dyads in months
Feasibility as measured by time to identify and recruit dyads in months (benchmark 3 months)
Measured: At 2 months
Data collection completion rate
Feasibility as measured by completion of data collection across study timepoints
Measured: At 2 months
Secondary outcomes (3)
NCCN Distress Thermometer scores
Caregiver Distress as measured by NCCN Distress Thermometer scores
Measured: At baseline and at 2 months
PROMISR Short Form v1.0 - Anxiety
Caregiver Anxiety as measured by PROMISR Short Form v1.0 - Anxiety scores. Scores range from 1 to 5, with higher scores indicating worse anxiety
Measured: At baseline and at 2 months
PROMISRv.1.2 - GlobalHealth scores
Caregiver Health Related Quality of Life as measured by PROMISRv.1.2-GlobalHealth scores. HRQOL scores range from 1 to 5, with higher scores indicating better outcomes
Measured: At baseline and at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study startJun 2021 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver AnxietyStudies of the same condition, open and under way.
- More trials run by Case Comprehensive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Douglas, PhD, RN, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639700
- Sponsor's protocol ID
- CASE14Z20
- Status last verified
- May 2021
- First submitted
- 19 Nov 2020
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study to only test the intervention so the data would not be useful to participants until a larger study (with control and intervention groups) is completed in the future
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Feasibility of an Intervention for Caregivers of Patients Who Have Recently Undergone HSCT
- ClinicalTrials.gov ID
- NCT04639700
- Acronym / sponsor ID
- CASE14Z20
- Keywords
- Hematopoietic stem cell transplantation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 20 Nov 2020 (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.
The purpose of this study is to find out if providing support to caregivers of patients who have recently had a HSCT is possible and helpful.
Detailed description
This study will test the feasibility, acceptability, usability, satisfaction and preliminary efficacy of a behavioral (psychoeducation) intervention. All participants will receive the standard post-hospital HSCT information for patient follow-up care as provided by the patient's oncologist. In addition, the all participants will receive 4 individual sessions with an interventionist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psycho-educational intervention | Experimental | Behavioral: Psycho-educational interventionAll participants will receive receive 4 individual sessions with an interventionist in addition to the standard post-hospital HSCT information for patient follow-up care as provided by the patient's oncologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- An adult family or friend of a patient who has been discharged from the hospital in the past 1-2 weeks after receiving HSCT
- Identifies himself/herself as the caregiver who will be responsible for the patient's care post-HSCT
- Has English as their primary language
Key exclusion criteria (1 listed)
- -Not meeting inclusion criteria
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 |
|---|---|---|
| Psycho-educational interventionParticipant will be sent a baseline survey, and will then be contacted by the interventionist to complete 4 sessions, which feature the following areas: Session 1: Identifying CG Needs for Information \& Support, Communication with Healthcare Team Session 2: Communication with Patient and Family Session 3: Self-care: Emotional \& Spiritual Needs, Self-care: Physical Needs Session 4: Re-Assessing Needs, Planning for the future | Behavioural | Psycho-educational intervention |
Primary outcome
Acceptability Scale scores
Time frame: At 2 months
Caregiver Acceptability as measured by Acceptability Scale scores. Overall score ranging from 6-30. According to prior research, a score of 80% of higher (total score of 24 or higher) is considered acceptable for use.
System Usability Scale scores
Time frame: At 2 months
Caregiver Usability as measured by the System Usability Scale. This is a 10 item scale scored on a 5 point Likert scale with total summed scores ranging from 0-50. Total scores are multiplied by 2 to produce an overall score ranging from 0-100 with scores > 68 considered to be above average usability
Mean caregiver satisfaction scores
Time frame: At the end of each intervention session and end of study evaluation, up to 2 months
Caregiver Satisfaction scores as measured by Likert Scale. After completing each module, they will be sent via REDCap a single item evaluation scale (0 -10; 0=Not at all satisfied; 10=Highly satisfied). Scores >7 will be considered acceptable. Mean and standard deviation will be reported.
Percent of enrollment of eligible participants
Time frame: At 2 months
Feasibility as measured by percent of enrollment of eligible participants
Percent of participants completing intervention
Time frame: At 2 months
Feasibility as measured by intervention completion
Retention rate
Time frame: At 2 months
Feasibility as measured by percent of participants retained in full study (aim: 90% retention at the end of the 2-month intervention)
Average time to recruit dyads in months
Time frame: At 2 months
Feasibility as measured by time to identify and recruit dyads in months (benchmark 3 months)
Data collection completion rate
Time frame: At 2 months
Feasibility as measured by completion of data collection across study timepoints
3 secondary outcomes
NCCN Distress Thermometer scores
Time frame: At baseline and at 2 months
PROMISR Short Form v1.0 - Anxiety
Time frame: At baseline and at 2 months
PROMISRv.1.2 - GlobalHealth scores
Time frame: At baseline and at 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
- Individual participant dataSharing planned: No. This is a pilot study to only test the intervention so the data would not be useful to participants until a larger study (with control and intervention groups) is completed in the future
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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.
Sara Douglas, PhD, RN principal investigator
Case Western Reserve University
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-educational intervention in people with Caregiver Anxiety and Caregiver Distress, run by Case Comprehensive Cancer Center.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Acceptability Scale scores (time frame: At 2 months). The study lists 8 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 25 May 2021.