Care GiversNCT02697357
Emotion Regulation Therapy to Address Distress Among Caregivers
An observational study of Care Givers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include partners, family members, children, parents, and friends providing informal care to a patient. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Care Givers
- What is being tested?
- Psychosocial Instruments and Emotion Regulation Therapy for Cancer Caregivers (ERT-C)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 9 Jul 2020
- 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: Participants will be recruited from outpatient clinics in various departments at MSKCC, including the Department of Psychiatry \& Behavioral Sciences, Social Work, Neurology, Integrative Medicine and Bone Marrow Transplant services.
Who may be able to join
- As per self-report, age 18 or over
- As per self-report, a current caregiver to a patient with any site or stage of cancer
- score of ≥ 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role. Potential participants will be asked whether or not their distress is in any way related to their caregiving experience. Individuals who answer "no" will be asked whether or not their distress started or has gotten worse since the patient began treatment or was diagnosed.
- Either a score of ≥ 15 on the Brief Penn State Worry Questionnaire OR a score > 12 on the Brooding Subscale of the Rumination Response Scale
- In the judgment of the investigators and/or consenting professional, able to read and comprehend English
- In the judgment of the consenting professional cognitively able to provide informed consent
Who cannot join
- As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
- In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
- If participating in optional biospecimen collection;as per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease)
- As per self-report, is a regular smoker (daily use)
- As per self-report, is a heavy drinker (regularly having more than 14 alcoholic beverages per week for men, 7 for women)
- As per self- report, engaging in night shift work
- As per self- report, currently engaged in ongoing psychotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include partners, family members, children, parents, and friends providing informal care to a patient. Providing care to someone with cancer can be difficult. The purpose of this intervention is to improve coping and physical well-being among caregivers, which in turn will allow them to provide better care for their loved ones. Investigators would also like to learn about biological factors like stress that may affect one's emotional and physical well-being. This study will allow to better understand caregivers needs, and further develop a program to provide services to caregivers within MSKCC community and nationwide.
- Conditions
- Care Givers
- Being tested
- Psychosocial Instruments, Emotion Regulation Therapy for Cancer Caregivers (ERT-C)
- Keywords
- Emotion Regulation Therapy, Distress Among Caregivers, 15-219
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial InstrumentsBehavioural
Emotion Regulation Therapy for Cancer Caregivers (ERT-C)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Caregivers | This study is a pilot, single-arm intervention of Emotion Regulation Therapy for Cancer Caregivers (ERT-C). We plan to recruit a pilot sample 32 consented (24 evaluable) caregivers of patients diagnosed with cancer and measure their distress, anxiety, and other psychological outcomes at baseline. Caregivers will be consented into an 8-session ERT-C therapy (approximately 12 - 16 weeks). Receives: Behavioral: Psychosocial Instruments; Behavioral: Emotion Regulation Therapy for Cancer Caregivers (ERT-C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients completing at least 6 out of the 8-sessions
feedback from participants by qualitative research methods
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startOct 2015
- Primary completion9 Jul 2020
- Study completion9 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care GiversStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hunter College of City University of New York, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Allison Applebaum, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697357
- Sponsor's protocol ID
- 15-219
- Status last verified
- Jul 2020
- First submitted
- 24 Feb 2016
- Last updated
- 13 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation Therapy to Address Distress Among Caregivers
- ClinicalTrials.gov ID
- NCT02697357
- Acronym / sponsor ID
- 15-219
- Conditions
- Care Givers
- Keywords
- Emotion Regulation Therapy, Distress Among Caregivers, 15-219
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Hunter College of City University of New York, Weill Medical College of Cornell University
- Study start
- Oct 2015 (actual)
- Primary completion
- 9 Jul 2020 (actual)
- Study completion
- 9 Jul 2020 (actual)
- First posted
- 3 Mar 2016 (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.
The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation Therapy (ERT-C) for informal caregivers of patients with cancer. Informal caregivers include partners, family members, children, parents, and friends providing informal care to a patient. Providing care to someone with cancer can be difficult. The purpose of this intervention is to improve coping and physical well-being among caregivers, which in turn will allow them to provide better care for their loved ones. Investigators would also like to learn about biological factors like stress that may affect one's emotional and physical well-being. This study will allow to better understand caregivers needs, and further develop a program to provide services to caregivers within MSKCC community and nationwide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregivers | – | Behavioral: Psychosocial Instruments, Behavioral: Emotion Regulation Therapy for Cancer Caregivers (ERT-C)This study is a pilot, single-arm intervention of Emotion Regulation Therapy for Cancer Caregivers (ERT-C). We plan to recruit a pilot sample 32 consented (24 evaluable) caregivers of patients diagnosed with cancer and measure their distress, anxiety, and other psychological outcomes at baseline. Caregivers will be consented into an 8-session ERT-C therapy (approximately 12 - 16 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from outpatient clinics in various departments at MSKCC, including the Department of Psychiatry \& Behavioral Sciences, Social Work, Neurology, Integrative Medicine and Bone Marrow Transplant services.
Key inclusion criteria (6 listed)
- As per self-report, age 18 or over
- As per self-report, a current caregiver to a patient with any site or stage of cancer
- score of ≥ 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role. Potential participants will be asked whether or not their distress is in any way related to their caregiving experience. Individuals who answer "no" will be asked whether or not their distress started or has gotten worse since the patient began treatment or was diagnosed.
- Either a score of ≥ 15 on the Brief Penn State Worry Questionnaire OR a score > 12 on the Brooding Subscale of the Rumination Response Scale
- In the judgment of the investigators and/or consenting professional, able to read and comprehend English
Key exclusion criteria (7 listed)
- As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
- In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
- If participating in optional biospecimen collection;as per self-report, has medical conditions that affect the immune system and would confound immune evaluation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease)
- As per self-report, is a regular smoker (daily use)
- As per self-report, is a heavy drinker (regularly having more than 14 alcoholic beverages per week for men, 7 for women)
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 |
|---|---|---|
| Psychosocial Instruments | Behavioural | Caregivers |
| Emotion Regulation Therapy for Cancer Caregivers (ERT-C) | Behavioural | Caregivers |
Primary outcome
number of patients completing at least 6 out of the 8-sessions
Time frame: 1 year
feedback from participants by qualitative research methods
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 13 Jul 2020.
- Memorial Sloan Kettering Cancer CenterLink 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.
Allison Applebaum, PhD principal investigator
Memorial Sloan Kettering 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 Care Givers, run by Memorial Sloan Kettering 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 6 inclusion and 7 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 13 Jul 2020. 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?
number of patients completing at least 6 out of the 8-sessions (time frame: 1 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 13 Jul 2020.