NCT07852858

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable cancer

Timeline
80mo left

Started Mar 2027

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2027

Expected
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2031

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2033

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

4.6 years

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Through study completion; an average of 1 year

Study Arms (2)

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

Interventions

Participants will receive one 60 min. session per week for 6 weeks (4 sessions, 240 min. total).

CTL: Patients Receive Cancer Treatment Per Usual Care (UC) Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 ≤ 2122
  • 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.

You may not qualify if:

  • 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) participants in individual, couple and/or family psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Kathrin Milbury, MA, PHD

    UT MD Anderson

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Milbury, MA, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 1, 2026

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

September 30, 2031

Study Completion (Estimated)

September 30, 2033

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations