CaregiverPATH-CNCT05216978
Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing HSCT
A study testing Positive Psychology Intervention in people with Caregiver and Hematologic Malignancy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Caregivers (i.e., family and friends) of patients with cancer are essential in providing care during cancer treatment. For patients who are undergoing a hematopoietic stem cell transplant/transplantation (HSCT) as treatment for their cancer, caregivers are even more crucial before, during, and after their… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver, Hematologic Malignancy
- What is being tested?
- Positive Psychology Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult caregivers (≥18 years) of patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) at Dana-Farber Cancer Institute (DCFI).
- A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for HSCT.
- Ability to speak English and able to complete questionnaires with minimum assistance of an interpreter.
Who cannot join
- Cognitive deficits impeding a caregiver's ability to provide informed consent or participate adequately in the study assessed via a commonly used 6-item cognitive assessment, the Brief Interview for Mental Status (BIMS) screening tool, which is sensitive and specific for screening for cognitive impairment in research subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
Caregivers (i.e., family and friends) of patients with cancer are essential in providing care during cancer treatment. For patients who are undergoing a hematopoietic stem cell transplant/transplantation (HSCT) as treatment for their cancer, caregivers are even more crucial before, during, and after their transplantation. Although HSCT is potentially curative for some patients with blood cancers, the treatment is intensive and accompanied by a prolonged hospitalization as patients recover from the toxic side-effects of chemotherapy and medical complications from the transplantation. Unsurprisingly, during the entire transplantation process, caregiver burden is high as caregivers witness and support their loved ones through multiple treatment-related complications, management of ongoing physical symptoms, and complex medication schedules. Caregiver burden leads to poor health outcomes including poor caregiver quality of life, fatigue, depression, anxiety, impaired physical health, and low levels of resilience and positive emotions. Reducing distress and enhancing positive emotions can both reduce caregiver burden and improve caregiver quality of life. However, the few interventions in the HSCT caregiver population have mostly focused on mitigating distress, despite strong evidence that enhancing positive emotions in caregivers reduces caregiver burden and promotes physical and psychological health. To address this gap, we hope to develop and test an intervention that emphasizes positive emotions in caregivers of HSCT recipients. A scalable and accessible positive emotion-based intervention tailored to the unique needs of HSCT recipients' caregivers provides a new line of behavioral intervention resources that could offer benefit to both caregivers and patients and could be generalizable to other cancer caregivers.
Read the detailed description
The proposed project (PATH-C) entails two phases:
- Phase one is an open-pilot trial in 5 caregivers of patients undergoing HSCT to refine the PATH intervention.
- Phase two is single-arm open-pilot trial evaluating the feasibility and acceptability of the PATH intervention in 20 caregivers of patients undergoing HSCT.
All participants will be approached in-person at the routine HSCT patient consent clinic visit or, with patient permission, over the phone if the caregiver is not physically present at the consent visit for eligibility determination. Interested participants will be screened based on the inclusion/exclusion criteria and verbal consent will be obtained.
Upon consent to participate in the study, participants in both phases will be asked to complete baseline questionnaires either in-person, over the phone, or via a REDCap survey link to participants. After baseline assessments are completed, participants will be given an intervention manual with 9-weekly positive psychology (PP) exercises and an explanation of the exercises and intervention.
All participants in Phases 1 and 2 will be asked to complete the 9-weekly PP exercises starting after the baseline questionnaires (i.e., after the patient transplant consent visit) are completed in the pre-transplant phase and to speak with the study interventionist, a trained clinical research coordinator (CRC), weekly. Immediately after the completion of each exercise, participants will rate the ease of exercise completion, overall utility of the exercise, and their current levels of positive affect. After the Week 9 intervention phone session, all participants in both phases will complete another set of self-assessment questionnaires either over the phone, in-person at a routine clinic visit, or via a REDCap survey link emailed to participants. Additionally, participants will be asked to complete a recorded exit interview over the phone. These individual, semi-structured exit interviews will elicit feedback about the intervention (e.g., relevance and applicability of the chosen PP exercises, intervention length, timing, and delivery), study procedures, and questionnaires. Exit interviews will be recorded, transcribed, coded and thematically analyzed. At study completion, we will inquire about participants' potential interest in being contacted about our future studies.
- Conditions
- Caregiver, Hematologic Malignancy
- Being tested
- Positive Psychology Intervention
- Keywords
- Positive Psychology Intervention, Hematopoietic Stem Cell Transplant, Caregivers of Patients with Cancer
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Psychology InterventionBehavioural
Weekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
| Study group | Role | What they receive |
|---|---|---|
| PATH Intervention | Experimental | Participants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment.
After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities).
Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention. Receives: Behavioral: Positive Psychology Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the PATH Intervention
Feasibility of the refined PATH intervention and our assessment battery in caregivers of patients who have undergone hematopoietic stem cell transplant (HSCT) using a single-arm trial.
Measured: 9 weeks
Acceptability Rate
At the end of each weekly intervention session, acceptability was measured with ratings of ease and utility of each positive psychology exercise with a 10-point Likert scale (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Mar 2022
- Primary completion8 Jun 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Model description
- All participants will receive the PATH intervention.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermioni L.Amonoo, MD, MPP, MPH, Brigham and Women's Hospital
- Investigators
- Hermioni L Amonoo, MD, MPP, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216978
- Sponsor's protocol ID
- 21-596
- Acronym
- PATH-C
- Status last verified
- Jun 2024
- First submitted
- 20 Dec 2021
- Last updated
- 1 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept Trial of a Positive Psychology Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05216978
- Acronym / sponsor ID
- PATH-C / 21-596
- Conditions
- Caregiver, Hematologic Malignancy
- Keywords
- Positive Psychology Intervention, Hematopoietic Stem Cell Transplant, Caregivers of Patients with Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Posted 1 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Caregivers (i.e., family and friends) of patients with cancer are essential in providing care during cancer treatment. For patients who are undergoing a hematopoietic stem cell transplant/transplantation (HSCT) as treatment for their cancer, caregivers are even more crucial before, during, and after their transplantation. Although HSCT is potentially curative for some patients with blood cancers, the treatment is intensive and accompanied by a prolonged hospitalization as patients recover from the toxic side-effects of chemotherapy and medical complications from the transplantation. Unsurprisingly, during the entire transplantation process, caregiver burden is high as caregivers witness and support their loved ones through multiple treatment-related complications, management of ongoing physical symptoms, and complex medication schedules. Caregiver burden leads to poor health outcomes including poor caregiver quality of life, fatigue, depression, anxiety, impaired physical health, and low levels of resilience and positive emotions. Reducing distress and enhancing positive emotions can both reduce caregiver burden and improve caregiver quality of life. However, the few interventions in the HSCT caregiver population have mostly focused on mitigating distress, despite strong evidence that enhancing positive emotions in caregivers reduces caregiver burden and promotes physical and psychological health. To address this gap, we hope to develop and test an intervention that emphasizes positive emotions in caregivers of HSCT recipients. A scalable and accessible positive emotion-based intervention tailored to the unique needs of HSCT recipients' caregivers provides a new line of behavioral intervention resources that could offer benefit to both caregivers and patients and could be generalizable to other cancer caregivers.
Detailed description
The proposed project (PATH-C) entails two phases:
- Phase one is an open-pilot trial in 5 caregivers of patients undergoing HSCT to refine the PATH intervention.
- Phase two is single-arm open-pilot trial evaluating the feasibility and acceptability of the PATH intervention in 20 caregivers of patients undergoing HSCT.
All participants will be approached in-person at the routine HSCT patient consent clinic visit or, with patient permission, over the phone if the caregiver is not physically present at the consent visit for eligibility determination. Interested participants will be screened based on the inclusion/exclusion criteria and verbal consent will be obtained.
Upon consent to participate in the study, participants in both phases will be asked to complete baseline questionnaires either in-person, over the phone, or via a REDCap survey link to participants. After baseline assessments are completed, participants will be given an intervention manual with 9-weekly positive psychology (PP) exercises and an explanation of the exercises and intervention.
All participants in Phases 1 and 2 will be asked to complete the 9-weekly PP exercises starting after the baseline questionnaires (i.e., after the patient transplant consent visit) are completed in the pre-transplant phase and to speak with the study interventionist, a trained clinical research coordinator (CRC), weekly. Immediately after the completion of each exercise, participants will rate the ease of exercise completion, overall utility of the exercise, and their current levels of positive affect. After the Week 9 intervention phone session, all participants in both phases will complete another set of self-assessment questionnaires either over the phone, in-person at a routine clinic visit, or via a REDCap survey link emailed to participants. Additionally, participants will be asked to complete a recorded exit interview over the phone. These individual, semi-structured exit interviews will elicit feedback about the intervention (e.g., relevance and applicability of the chosen PP exercises, intervention length, timing, and delivery), study procedures, and questionnaires. Exit interviews will be recorded, transcribed, coded and thematically analyzed. At study completion, we will inquire about participants' potential interest in being contacted about our future studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the PATH intervention.
| Arm | Type | Receives |
|---|---|---|
| PATH Intervention | Experimental | Behavioral: Positive Psychology InterventionParticipants in the PATH Intervention arm will receive psychosocial support phone calls during week 1 through 9 following enrollment. After consent procedures, participants will begin an 9-week positive-psychology program involving weekly calls with an interventionist and exercises (i.e. writing a letter of gratitude, identifying personal strengths, planning meaningful and enjoyable activities). Self-assessment questionnaires to measure positive affect, health behaviors, and overall function before and after completing the Positive Psychology Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult caregivers (≥18 years) of patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) at Dana-Farber Cancer Institute (DCFI).
- A relative or a friend who either lives with the patient or has in-person contact with him or her at least twice per week and is identified as the primary caregiver for HSCT.
- Ability to speak English and able to complete questionnaires with minimum assistance of an interpreter.
Key exclusion criteria (1 listed)
- Cognitive deficits impeding a caregiver's ability to provide informed consent or participate adequately in the study assessed via a commonly used 6-item cognitive assessment, the Brief Interview for Mental Status (BIMS) screening tool, which is sensitive and specific for screening for cognitive impairment in research subjects.
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 |
|---|---|---|
| Positive Psychology InterventionWeekly phone calls with the study interventionist and positive psychology exercises over an 9-week period. The positive psychology program exercises include three modules: gratitude-based activities, strength-based activities, and meaning-based activities. | Behavioural | PATH Intervention |
Primary outcome
Feasibility of the PATH Intervention
Time frame: 9 weeks
Feasibility of the refined PATH intervention and our assessment battery in caregivers of patients who have undergone hematopoietic stem cell transplant (HSCT) using a single-arm trial.
Acceptability Rate
Time frame: 9 weeks
At the end of each weekly intervention session, acceptability was measured with ratings of ease and utility of each positive psychology exercise with a 10-point Likert scale (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Hermioni L Amonoo, MD, MPP, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychology Intervention in people with Caregiver and Hematologic Malignancy, run by Brigham and Women's Hospital 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 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: finished, as of the sponsor's last update on 1 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of the PATH Intervention (time frame: 9 weeks). The study lists 2 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 1 Jul 2024.