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

Not Applicable

Recruiting

• Conditions: Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm
• Interventions: Other: Best Practice; Other: Educational Intervention; Other: Questionnaire Administration

• Registration Number: NCT05059678
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-28
• Study Start: 2021-11-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (education material, videoconference session)	Questionnaire Administration	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 (waitlist control)	Best Practice	Participants receive standard of care.
Group I (education material, videoconference session)	Educational Intervention	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 (waitlist control)	Questionnaire Administration	Participants receive standard of care.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States