Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05059678

Parenting Support Intervention for Families Coping With Metastatic or Locally Recurrent Solid Tumor Diagnosis

This clinical trial examines the acceptability and effect of a parenting support intervention for families coping with solid tumor that has spread to other places in the body (metastatic) or has come back (recurrent). Parenting support program may help to reduce common parenting concerns, improve communication between parents and children about cancer, and improve the overall psychological wellbeing of parents.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Kathrin Milbury

CONTACT

[email protected]

713-745-2868

Kathrin Milbury

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

I. Examine the acceptability a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers. (Trial 1) II. Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers. (Trial 2) III. Evaluate the initial evidence for intervention efficacy relative to waitlist control (WLC) group regarding patient and spousal caregiver psychological symptoms (primary outcome) and parenting concerns and parenting efficacy (secondary outcomes) and patient end of life (EOL) healthcare utilization (exploratory outcome). (Trial 2) IV. Understand the patients and caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research. (Trial 2)

OUTLINE:

TRIAL 1: Participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. Caregivers attend 2 additional weekly intervention sessions over 45 minutes each.

TRIAL 2: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive education materials (brochure and a video) and attend 2 weekly videoconference intervention sessions over 45 minutes each. Caregivers attend 2 additional weekly intervention sessions over 45 minutes each.

GROUP II: Participants receive standard of care.

After completion of study, participants in Trial 1 are followed up at 6 and 12 weeks and participants in Trial 2 are followed up at 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must (1) be diagnosed with a metastatic or locally recurrent solid malignant tumor and on active treatment; (2) be at least 18 years old; (3) have at least one dependent child between the ages of 4 and 16 and currently living with the parent; (4) be able to provide informed consent and (5) have a spousal caregiver over the age of 18 who co-parents the child(ren) (i.e. share custody) and is willing and able to consent to participate.*

Exclusion criteria

  • Participants and caregivers who do not read and speak English and who do not have access to the internet.

Treatment and study plan

Best Practice

Other

Receive standard of care

Other names: standard of care, standard therapy

Educational Intervention

Other

Receive educational materials and attend videoconference sessions

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers.

    Time frame: Through study completion, an average of 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Kathrin Milbury

CONTACT

[email protected]

713-745-2868

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Parenting Support Intervention for Families Coping With an Advanced Cancer Diagnosis

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 28, 2021
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.