Cancer Care RecipientNCT02166866
Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout
An observational study of Cancer Care Recipient, run by Mayo Clinic at 1 site in United States.
Trial summary
This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Care Recipient
- What is being tested?
- Quality of Life Questionairre and Education
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2013to 27 Jun 2018
- 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: Caregivers will be recruited through the Mayo Clinic inpatient and outpatient services, including but not limited to referrals from staff of the Divisions of Medical Oncology, Hematology, and Radiation Oncology and other clinics in the outpatient setting, and Divisions of HospitalMedicine, Hospice and Palliative Medicine, and other inpatient services in the hospital setting. This population was chosen as they are likely to experience caregiver-related distress for which the intervention will be beneficial.
Who may be able to join
- Ability to provide written informed consent.
- Ability to speak, read, write and understand English language
- Has cancer caregiver status defined as an unpaid individual who provides physical, practical, and/or emotional care and support to a cancer care recipient in the home or other healthcare setting.
- Has a care recipient:
- ≥ 18 years of age who
- has a malignancy (either solid tumor or hematologic) diagnosis.
Show all 9Show fewer
- who has signed a research authorization form
- who is undergoing or in the last 6 months has undergone cancer treatment
- Ability to use and access to a computer, tablet or other device with internet access and video capabilities
Who cannot join
- Diagnosis within the past 12 months of active substance abuse (alcohol or drugs)
- Diagnosis within the past 12 months of active mental health condition that has required psychiatric hospitalization
- Diagnosis within the past 12 months of suicidal thoughts or attempt
- Care recipient is currently participating in another psychosocial clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.
- Conditions
- Cancer Care Recipient
- Being tested
- Quality of Life Questionairre and Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life Questionairre and EducationOther
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Not described Receives: Other: Quality of Life Questionairre and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
calculate the average number of caregivers participating in each offered web-based session
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study start9 Sep 2013
- Primary completion5 May 2015
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Care RecipientStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166866
- Sponsor's protocol ID
- MC1295
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2014
- Last updated
- 29 Jun 2018
- Results posted
- No
Publications
Lapid MI, Atherton PJ, Kung S, Clark MM, Sloan JA, Whitford KJ, Hubbard JM, Gentry MT, Miller JJ, Rummans TA. A feasibility study of virtual group therapy to improve quality of life of cancer caregivers. J Psychosoc Oncol. 2022;40(6):854-867. doi: 10.1080/07347332.2021.2000550. Epub 2021 Nov 29.
PubMed 34842060
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout
- ClinicalTrials.gov ID
- NCT02166866
- Acronym / sponsor ID
- MC1295
- Conditions
- Cancer Care Recipient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 9 Sep 2013 (actual)
- Primary completion
- 5 May 2015 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 18 Jun 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.
This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | – | Other: Quality of Life Questionairre and Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers will be recruited through the Mayo Clinic inpatient and outpatient services, including but not limited to referrals from staff of the Divisions of Medical Oncology, Hematology, and Radiation Oncology and other clinics in the outpatient setting, and Divisions of HospitalMedicine, Hospice and Palliative Medicine, and other inpatient services in the hospital setting. This population was chosen as they are likely to experience caregiver-related distress for which the intervention will be beneficial.
Key inclusion criteria (9 listed)
- Ability to provide written informed consent.
- Ability to speak, read, write and understand English language
- Has cancer caregiver status defined as an unpaid individual who provides physical, practical, and/or emotional care and support to a cancer care recipient in the home or other healthcare setting.
- Has a care recipient:
- Ability to use and access to a computer, tablet or other device with internet access and video capabilities
Key exclusion criteria (4 listed)
- Diagnosis within the past 12 months of active substance abuse (alcohol or drugs)
- Diagnosis within the past 12 months of active mental health condition that has required psychiatric hospitalization
- Diagnosis within the past 12 months of suicidal thoughts or attempt
- Care recipient is currently participating in another psychosocial clinical trial
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 |
|---|---|---|
| Quality of Life Questionairre and Education | Other | Experimental arm |
Primary outcome
calculate the average number of caregivers participating in each offered web-based session
Time frame: 6 months
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 29 Jun 2018.
- Derived from this study: PubMed 34842060Lapid MI, Atherton PJ, Kung S, Clark MM, Sloan JA, Whitford KJ, Hubbard JM, Gentry MT, Miller JJ, Rummans TA. A feasibility study of virtual group therapy to improve quality of life of cancer caregivers. J Psychosoc Oncol. 2022;40(6):854-867. doi: 10.1080/07347332.2021.2000550. Epub 2021 Nov 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer Care Recipient, run by Mayo Clinic 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 9 inclusion and 4 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 29 Jun 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?
calculate the average number of caregivers participating in each offered web-based session (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166866, which also lists 1 linked publication.
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 29 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.