NeoplasmsNCT03210727
CAREgiver Study for Patients Undergoing HSCT
A study testing Ready to CARE program in people with Neoplasms, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The investigators will use a single arm design and deliver a new supportive intervention entitled, "Ready to Connect, Actively Relax and Exercise (CARE)." The purpose of the study is to describe the feasibility, acceptability, and potential effectiveness of the Ready to CARE intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- Ready to CARE program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 29 Aug 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
- Providing informal, unpaid care for a person who is 18 years of age or older and is scheduled to receive an allogeneic or autologous HSCT within the next three months.
- The caregiver's loved one ("patient") undergoing the transplant will be asked to enroll in the study to provide data regarding quality of life and symptom burden and to allow access of the medical record to ascertain healthcare utilization data. (Caregivers will not be excluded from the study if the patient declines to enroll.)
Who cannot join
- Under the age of 18 for either caregiver or patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Mixed Methods Descriptive Study Exploring the Needs and Preferences of Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
The investigators will use a single arm design and deliver a new supportive intervention entitled, "Ready to Connect, Actively Relax and Exercise (CARE)." The purpose of the study is to describe the feasibility, acceptability, and potential effectiveness of the Ready to CARE intervention. Effectiveness outcomes include caregiver self-efficacy, distress, and coping style, and patient quality of life, symptom burden, and healthcare utilization.
Read the detailed description
During the first phase of this study, the investigators enrolled caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT) into a descriptive study. The investigators used quantitative and qualitative measures to describe the caregivers self-efficacy, distress, and coping style, and solicit their opinions about how to improve our supportive care for caregivers.
Informed by those data, the investigators now will study the effectiveness of the supportive intervention.
The long-term goal of this research is to develop a pragmatic, replicable intervention that supports caregivers and promotes the health and well-being of the caregiver-HSCT patient dyad.
- Conditions
- Neoplasms
- Being tested
- Ready to CARE program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready to CARE programBehavioural
The intervention is built upon a model of caregiver well-being that identifies four domains of quality of life: physical, psychological, social, and spiritual well-being. For each domain, there are stressors (i.e., factors that make it hard to be a caregiver) and buffers (i.e., factors that help people be effective caregivers). Our Ready to CARE intervention begins by presenting caregivers with the model in order to generate a profile of personal stressors and buffers. From there, caregivers select from a "menu" of strategies that can be used to minimize stressors and create buffers in their daily life. The investigators will have six 45-minute sessions with the caregivers that will primarily occur while the patient is admitted for stem cell reinfusion.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Other | This arm will be used to pilot test the Ready to CARE program (with the caregivers) and measure outcomes (in the patients). Receives: Behavioral: Ready to CARE program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment statistics
Number enrolled in study divided by number eligible
Measured: Throughout the study, an average of one year
Secondary outcomes (9)
Retention
number completing all study assessments divided by number enrolled
Measured: Throughout the study, an average of one year
Goal Attainment
average goal attainment score between sessions
Measured: Day 30 after stem cell reinfusion
Session Completion
Average number of sessions completed
Measured: Day 30 after stem cell reinfusion
Caregiver Satisfaction
Average score on satisfaction survey
Measured: Day 30 after stem cell reinfusion
Caregiver Self-efficacy
Average change score on Caregiver Self-efficacy Scale
Measured: Day 100 after stem cell reinfusion
Caregiver Coping style
Average change score on Brief Cope
Measured: Day 100 after stem cell reinfusion
Patient Quality of Life
Average change score on Functional Assessment of Cancer Therapy- Bone Marrow Transplant
Measured: Day 100 after stem cell reinfusion
Patient symptom burden
Average change score on MD Anderson Symptom Inventory
Measured: Day 100 after stem cell reinfusion
Patient healthcare utilization
Average number of re-hospitalizations, urgent care or emergency department visits, and telephone calls to bone marrow transplant program
Measured: Day 100 after stem cell reinfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start25 Jul 2017
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- a single arm design will be used to pilot test the Ready to CARE program with 20 caregivers (while also measuring outcomes in the 20 patients receiving HSCT)..
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Lyons, Dartmouth-Hitchcock Medical Center
- Investigators
- Kathleen D Lyons, ScD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210727
- Sponsor's protocol ID
- D17033
- Status last verified
- Sep 2018
- First submitted
- 3 Jul 2017
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed Methods Descriptive Study Exploring the Needs and Preferences of Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
- ClinicalTrials.gov ID
- NCT03210727
- Acronym / sponsor ID
- D17033
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 7 Jul 2017 (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 investigators will use a single arm design and deliver a new supportive intervention entitled, "Ready to Connect, Actively Relax and Exercise (CARE)." The purpose of the study is to describe the feasibility, acceptability, and potential effectiveness of the Ready to CARE intervention. Effectiveness outcomes include caregiver self-efficacy, distress, and coping style, and patient quality of life, symptom burden, and healthcare utilization.
Detailed description
During the first phase of this study, the investigators enrolled caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT) into a descriptive study. The investigators used quantitative and qualitative measures to describe the caregivers self-efficacy, distress, and coping style, and solicit their opinions about how to improve our supportive care for caregivers.
Informed by those data, the investigators now will study the effectiveness of the supportive intervention.
The long-term goal of this research is to develop a pragmatic, replicable intervention that supports caregivers and promotes the health and well-being of the caregiver-HSCT patient dyad.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a single arm design will be used to pilot test the Ready to CARE program with 20 caregivers (while also measuring outcomes in the 20 patients receiving HSCT)..
| Arm | Type | Receives |
|---|---|---|
| single arm | Other | Behavioral: Ready to CARE programThis arm will be used to pilot test the Ready to CARE program (with the caregivers) and measure outcomes (in the patients). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Providing informal, unpaid care for a person who is 18 years of age or older and is scheduled to receive an allogeneic or autologous HSCT within the next three months.
- The caregiver's loved one ("patient") undergoing the transplant will be asked to enroll in the study to provide data regarding quality of life and symptom burden and to allow access of the medical record to ascertain healthcare utilization data. (Caregivers will not be excluded from the study if the patient declines to enroll.)
Key exclusion criteria (1 listed)
- Under the age of 18 for either caregiver or patient.
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 |
|---|---|---|
| Ready to CARE programThe intervention is built upon a model of caregiver well-being that identifies four domains of quality of life: physical, psychological, social, and spiritual well-being. For each domain, there are stressors (i.e., factors that make it hard to be a caregiver) and buffers (i.e., factors that help people be effective caregivers). Our Ready to CARE intervention begins by presenting caregivers with the model in order to generate a profile of personal stressors and buffers. From there, caregivers select from a "menu" of strategies that can be used to minimize stressors and create buffers in their daily life. The investigators will have six 45-minute sessions with the caregivers that will primarily occur while the patient is admitted for stem cell reinfusion. | Behavioural | single arm |
Primary outcome
Enrollment statistics
Time frame: Throughout the study, an average of one year
Number enrolled in study divided by number eligible
9 secondary outcomes
Retention
Time frame: Throughout the study, an average of one year
Goal Attainment
Time frame: Day 30 after stem cell reinfusion
Session Completion
Time frame: Day 30 after stem cell reinfusion
Caregiver Satisfaction
Time frame: Day 30 after stem cell reinfusion
Caregiver Self-efficacy
Time frame: Day 100 after stem cell reinfusion
Caregiver Coping style
Time frame: Day 100 after stem cell reinfusion
Patient Quality of Life
Time frame: Day 100 after stem cell reinfusion
Patient symptom burden
Time frame: Day 100 after stem cell reinfusion
Patient healthcare utilization
Time frame: Day 100 after stem cell reinfusion
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 20 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Kathleen D Lyons, ScD principal investigator
Dartmouth-Hitchcock Medical 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 Ready to CARE program in people with Neoplasms, run by Dartmouth-Hitchcock Medical 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 2 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: finished, as of the sponsor's last update on 20 Sep 2018. 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?
Enrollment statistics (time frame: Throughout the study, an average of one year). 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 20 Sep 2018.