CancerNCT05904782
Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients With Advanced Cancer
An observational study of Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn more about the experience and wellbeing of people who provide care for cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2025to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: MD Anderson Cancer Center
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Males and female adults ≥18 years
- Able to read and speak English
- Caregiver of a patient diagnosed with stage IV solid malignancy, with whom they have been residing for >6 months
- Access to necessary resources for participating in a technology-based intervention (i.e., telephone, internet access)
Who cannot join
- Current participation in consistent (self-defined) psychotherapy
- Caregivers who are considered part of a vulnerable population (i.e. cognitively impaired (self-reported or patient-reported), pregnant, military personnel) will not be eligible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Juliet Kroll, BA,PHD, 346-723-5858, jlkroll@mdanderson.org
Juliet Kroll, BA, PHD
About this study
To learn more about the experience and wellbeing of people who provide care for cancer patients.
Read the detailed description
OBJECTIVES
Primary Objectives:
The primary objective of this proposal is to identify relevant themes and content essential to adapt PAT to a caregiving in advanced cancer context (PAT-C) and develop a Brief (5-session) version of PAT-C. Findings from this study are essential to inform future RCTs to test the feasibility, efficacy, dose and explore potential mediators of treatment outcomes of this intervention.
Secondary Objectives:
The secondary objective is to characterize psychosocial distress and psychosocial health of caregivers in the supportive care clinic. This data will be essential to inform appropriateness of the supportive care clinic as a potential site for future RCTs (i.e., determine if there are enough caregivers in this clinic who might benefit from this specific supportive care strategy).
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life questionnaire (Qol)
Measured: through completion of study; approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start29 Aug 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Juliet Kroll, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904782
- Sponsor's protocol ID
- 2022-0940
- Other IDs
- NCI-2023-04226
- Status last verified
- Aug 2026
- First submitted
- 6 Jun 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Brief Positive Affect Treatment (PAT) for Caregivers of Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05904782
- Acronym / sponsor ID
- 2022-0940
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 15 Jun 2023 (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.
To learn more about the experience and wellbeing of people who provide care for cancer patients.
Detailed description
OBJECTIVES
Primary Objectives:
The primary objective of this proposal is to identify relevant themes and content essential to adapt PAT to a caregiving in advanced cancer context (PAT-C) and develop a Brief (5-session) version of PAT-C. Findings from this study are essential to inform future RCTs to test the feasibility, efficacy, dose and explore potential mediators of treatment outcomes of this intervention.
Secondary Objectives:
The secondary objective is to characterize psychosocial distress and psychosocial health of caregivers in the supportive care clinic. This data will be essential to inform appropriateness of the supportive care clinic as a potential site for future RCTs (i.e., determine if there are enough caregivers in this clinic who might benefit from this specific supportive care strategy).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Males and female adults ≥18 years
- Able to read and speak English
- Caregiver of a patient diagnosed with stage IV solid malignancy, with whom they have been residing for >6 months
Key exclusion criteria (2 listed)
- Current participation in consistent (self-defined) psychotherapy
- Caregivers who are considered part of a vulnerable population (i.e. cognitively impaired (self-reported or patient-reported), pregnant, military personnel) will not be eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life questionnaire (Qol)
Time frame: through completion of study; approximately 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- MD Anderson 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.
Juliet Kroll principal investigator
M.D. Anderson 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 Cancer, run by M.D. Anderson 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 2 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliet Kroll ((346) 723-5858, jlkroll@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life questionnaire (Qol) (time frame: through completion of study; approximately 1 month). 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 14 Aug 2026.