CaregiversNCT02250911
Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden
A study testing webcasts and Assessments in people with Caregivers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to gather information on how easy it is to implement the workshop, as well as whether individuals find this workshop helpful. In this study, participants will be assigned at random to one of the two study groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers
- What is being tested?
- webcasts and Assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 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
- As per self report, a current caregiver to a patient with any site or stage of cancer
- Age 18 or over
- A score of > 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role
- In the judgment of the investigators and/or consenting professional, able to comprehend English to complete study assessments
- Able to perform informed consent
- Enrollment is open to caregivers with their own current/past cancer histories
Who cannot join
- Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent.
- As per self report, unable to access a computer with Internet or unable to use a computer with Internet provided by the study
- Participated in the development and refinement of the CCC Workshop (prospective exemption X14-006)
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 purpose of this study is to gather information on how easy it is to implement the workshop, as well as whether individuals find this workshop helpful. In this study, participants will be assigned at random to one of the two study groups. Based on the information we obtain, we hope to develop an easily accessible support service for caregivers.
- Conditions
- Caregivers
- Being tested
- webcasts, Assessments, Usual care
- Keywords
- Caregivers of patients, CCC = Care for the Cancer Caregivers, MCP-C = Meaning-Centered Psychotherapy for Cancer Caregivers, 14-208
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
webcastsOther
AssessmentsBehavioural
Usual careOther
| Study group | Role | What they receive |
|---|---|---|
| This web-based CCC Workshop | Experimental | The Care for the Cancer Caregivers (CCC) workshop is composed of six webcasts. The Introductory Webcast is based upon Sessions 1 and 2 of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and provides participants with an introduction to the CCC Workshop, an overview of the different meaning-centered modules (i.e., legacy, choice, creativity, and connectedness), and a discussion about identity and how caregivers' identities have or have not changed since taking on this role. Receives: Other: webcasts; Behavioral: Assessments |
| Waitlist Control | Active comparator | Participants randomized to the waitlist control arm will be offered what is considered "usual care" at the ACS: the provision of the ACS Telephone Hotline number (1-800- 227-2345) and direction to the ACS website (www.cancer.org) where participants can find many resources for caregivers, including links to the ACS Caregiver ToolKit. They will complete assessments at time points that correspond with the completion of assessments in the CCC Workshop arm: after consent as soon as they are able (T1), about 2 months (± 4 weeks) after T1 (T2), and about 2-3 months after T2 (T3). Upon completion of all study assessments the waitlist control arm participants will be offered the opportunity to complete the CCC Workshop. Receives: Behavioral: Assessments; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of this novel approach
which will be measured by our ability to recruit our target sample and the proportion of participants who complete the CCC Workshop. Additional indices related to this aim (acceptability) will be gathered via both quantitative (entire sample) and qualitative (with a subset of participants randomized to received the CCC Workshop) methods.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Allison Applebaum, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250911
- Sponsor's protocol ID
- 14-208
- Status last verified
- Aug 2018
- First submitted
- 24 Sep 2014
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden
- ClinicalTrials.gov ID
- NCT02250911
- Acronym / sponsor ID
- 14-208
- Conditions
- Caregivers
- Keywords
- Caregivers of patients, CCC = Care for the Cancer Caregivers, MCP-C = Meaning-Centered Psychotherapy for Cancer Caregivers, 14-208
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- Sep 2014
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 26 Sep 2014 (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 purpose of this study is to gather information on how easy it is to implement the workshop, as well as whether individuals find this workshop helpful. In this study, participants will be assigned at random to one of the two study groups. Based on the information we obtain, we hope to develop an easily accessible support service for caregivers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| This web-based CCC Workshop | Experimental | Other: webcasts, Behavioral: AssessmentsThe Care for the Cancer Caregivers (CCC) workshop is composed of six webcasts. The Introductory Webcast is based upon Sessions 1 and 2 of Meaning-Centered Psychotherapy for Cancer Caregivers (MCP-C) and provides participants with an introduction to the CCC Workshop, an overview of the different meaning-centered modules (i.e., legacy, choice, creativity, and connectedness), and a discussion about identity and how caregivers' identities have or have not changed since taking on this role. |
| Waitlist Control | Active comparator | Behavioral: Assessments, Other: Usual careParticipants randomized to the waitlist control arm will be offered what is considered "usual care" at the ACS: the provision of the ACS Telephone Hotline number (1-800- 227-2345) and direction to the ACS website (www.cancer.org) where participants can find many resources for caregivers, including links to the ACS Caregiver ToolKit. They will complete assessments at time points that correspond with the completion of assessments in the CCC Workshop arm: after consent as soon as they are able (T1), about 2 months (± 4 weeks) after T1 (T2), and about 2-3 months after T2 (T3). Upon completion of all study assessments the waitlist control arm participants will be offered the opportunity to complete the CCC Workshop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- As per self report, a current caregiver to a patient with any site or stage of cancer
- Age 18 or over
- A score of > 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role
- In the judgment of the investigators and/or consenting professional, able to comprehend English to complete study assessments
- Able to perform informed consent
Key exclusion criteria (3 listed)
- Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent.
- As per self report, unable to access a computer with Internet or unable to use a computer with Internet provided by the study
- Participated in the development and refinement of the CCC Workshop (prospective exemption X14-006)
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 |
|---|---|---|
| webcasts | Other | This web-based CCC Workshop |
| Assessments | Behavioural | This web-based CCC Workshop, Waitlist Control |
| Usual care | Other | Waitlist Control |
Primary outcome
feasibility of this novel approach
Time frame: 2 years
which will be measured by our ability to recruit our target sample and the proportion of participants who complete the CCC Workshop. Additional indices related to this aim (acceptability) will be gathered via both quantitative (entire sample) and qualitative (with a subset of participants randomized to received the CCC Workshop) 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 10 Aug 2018.
- 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?
A study testing webcasts and Assessments in people with Caregivers, 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 3 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 10 Aug 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?
feasibility of this novel approach (time frame: 2 years). 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 10 Aug 2018.