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NCT05059678 Clinical Trial

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

Metastatic Malignant Solid Neoplasm Clinical Trial

Official title:
Parenting Support Intervention for Families Coping With an Advanced Cancer Diagnosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05059678
Other study ID # 2021-0380
Secondary ID NCI-2021-0915320
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2021
Est. completion date December 31, 2026

Study information
Verified date April 2024
Source M.D. Anderson Cancer Center
Contact Kathrin Milbury
Phone 713-745-2868
Email kmilbury@mdanderson.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must be diagnosed with a metastatic or locally recurrent solid malignant tumor - Patients must be at least 18 years old - Patients must have at least one dependent child between the ages of 4 and 12 and currently living with the parent - Patients must be able to provide informed consent - Patients must 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 - Patients with cognitive deficits that would impede the completion of self-report instruments as measured by the Mini Mental State Examination (score of =< 17) Exclusion Criteria: - Patients and caregivers who do not read and speak English and who do not have access to the internet

Study Design

Related Conditions & MeSH terms

  • Metastatic Malignant Solid Neoplasm
  • Neoplasms
  • Recurrent Malignant Solid Neoplasm

Intervention

Other:
• Best Practice
Receive standard of care
• Educational Intervention
Receive educational materials and attend videoconference sessions
• Questionnaire Administration
Ancillary studies

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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