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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Recurrent Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm

Treatments: Other: Educational Intervention; Other: Questionnaire Administration; Other: Best Practice

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05059678

2021-0380 (Other Identifier)

NCI-2021-09153 (Registry Identifier)

R21CA256694 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Group I (education material, videoconference session)

Experimental group

Description:

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).

Treatment:

Other: Questionnaire Administration

Other: Educational Intervention

Group II (waitlist control)

Active Comparator group

Description:

Participants receive standard of care.

Treatment:

Other: Best Practice

Other: Questionnaire Administration