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

NCT05059678 | Recruiting

• 3 other identifiers: 2021-0380NCI-2021-09153R21CA256694
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

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

  Through study completion, an average of 1 year

Study Arms (2)

Group I (education material, videoconference session)

EXPERIMENTAL

Examine the acceptability of a parenting support intervention in 10 patients with an incurable cancer and their spousal caregivers (cohort A) and 10 patients with an advanced cancer diagnosis and their family caregivers (cohort B).

Other: Educational Intervention; Other: Questionnaire Administration

Group II (waitlist control)

ACTIVE COMPARATOR

Participants receive standard of care.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Receive educational materials and attend videoconference sessions

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Group I (education material, videoconference session)

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Group II (waitlist control)

Questionnaire Administration OTHER

Ancillary studies

Group I (education material, videoconference session); Group II (waitlist control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.\*

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M.D. Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Kathrin Milbury

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Milbury

CONTACT

713-745-2868; kmilbury@mdanderson.org

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 10, 2021
• First Posted: September 28, 2021
• Study Start: November 30, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)