CancerNCT07852858
Supporting Families In Coping With Parental Cancer: A Multi-Site Randomized Controlled Trial
A study testing Parent Support Intervention in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this behavioral research study is to learn about the effect of a parent support intervention on cancer patients' and their family caregivers' mental wellbeing, and family functioning. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Parent Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Sep 2033
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecologic, or genitourinary cancer
- With at least one dependent child between the ages of 4 and 17 years and currently living with the parent
- ECOG performance status of ≤ 2
- With a spousal caregiver/partner who co-parents the child(ren) OR a family caregiver who offers care and support to both the patient and the child(ren) as determined by the patient.
- Patients and Caregivers:
- At least 18 years old;
- Able to read and speak English and/or Spanish.
Who cannot join
- Experiences cognitive deficits that would impede the completion of self-report instruments and intervention engagement as deemed by their attending oncologist per medical notes and/or patient not being oriented to time, place and person during the recruitment process
- Regularly (self-defined) participation in individual, couple and/or family psychotherapy
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
UT MD Anderson
Houston, Texas, 77030
Kathrin Milbury, MA, PHD, 713-745-2868, kmilbury@mdanderson.org
Kathrin Milbury, MA, PHD
About this study
The goal of this behavioral research study is to learn about the effect of a parent support intervention on cancer patients' and their family caregivers' mental wellbeing, and family functioning.
Read the detailed description
Primary Objectives:
- Examine the efficacy of the parent support intervention in improving patient anxiety symptoms (primary outcome), family anxiety symptoms (secondary outcomes) and patient and family depressive symptoms (exploratory outcome).
- Determine whether the parent support intervention improves family function (i.e., cancer-related parenting, family cohesion and parent-child communication) relative to the UC group, which in turn improves primary and secondary outcomes.
- Explore if the parent intervention improves patient end of life quality care and psychological adjustment in bereaved families using a mixed-method approach.
- Conditions
- Cancer
- Being tested
- Parent Support Intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Support InterventionBehavioural
Participants will receive one 60 min. session per week for 6 weeks (4 sessions, 240 min. total).
| Study group | Role | What they receive |
|---|---|---|
| CTL: Patients Receive Cancer Treatment Per Usual Care (UC) Control Group | Experimental | Not described Receives: Behavioral: Parent Support Intervention |
| INTERV: Parent - Caregiver Dyads TO The Parent Support Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2033 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathrin Milbury, MA, PHD, Principal investigator, UT MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852858
- Sponsor's protocol ID
- 2026-1079
- Other IDs
- NCI-2026-07199
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Families In Coping With Parental Cancer: A Multi-Site Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07852858
- Acronym / sponsor ID
- 2026-1079
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Sep 2031 (estimated)
- Study completion
- 30 Sep 2033 (estimated)
- First posted
- 1 Oct 2026 (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.
The goal of this behavioral research study is to learn about the effect of a parent support intervention on cancer patients' and their family caregivers' mental wellbeing, and family functioning.
Detailed description
Primary Objectives:
- Examine the efficacy of the parent support intervention in improving patient anxiety symptoms (primary outcome), family anxiety symptoms (secondary outcomes) and patient and family depressive symptoms (exploratory outcome).
- Determine whether the parent support intervention improves family function (i.e., cancer-related parenting, family cohesion and parent-child communication) relative to the UC group, which in turn improves primary and secondary outcomes.
- Explore if the parent intervention improves patient end of life quality care and psychological adjustment in bereaved families using a mixed-method approach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTL: Patients Receive Cancer Treatment Per Usual Care (UC) Control Group | Experimental | Behavioral: Parent Support Intervention |
| INTERV: Parent - Caregiver Dyads TO The Parent Support Intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecologic, or genitourinary cancer
- With at least one dependent child between the ages of 4 and 17 years and currently living with the parent
- ECOG performance status of ≤ 2
- With a spousal caregiver/partner who co-parents the child(ren) OR a family caregiver who offers care and support to both the patient and the child(ren) as determined by the patient.
- At least 18 years old;
Key exclusion criteria (2 listed)
- Experiences cognitive deficits that would impede the completion of self-report instruments and intervention engagement as deemed by their attending oncologist per medical notes and/or patient not being oriented to time, place and person during the recruitment process
- Regularly (self-defined) participation in individual, couple and/or family psychotherapy
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 |
|---|---|---|
| Parent Support InterventionParticipants will receive one 60 min. session per week for 6 weeks (4 sessions, 240 min. total). | Behavioural | CTL: Patients Receive Cancer Treatment Per Usual Care (UC) Control Group |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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 5 Oct 2026.
- UT MD Anderson WebsiteLink 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.
Kathrin Milbury, MA, PHD principal investigator
UT MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Support Intervention in people with 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 8 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: opening soon, as of the sponsor's last update on 5 Oct 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 Kathrin Milbury, MA, PHD ((713) 745-2868, kmilbury@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 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 5 Oct 2026.