Supporting Families In Coping With Parental Cancer: A Multi-Site Randomized Controlled Trial

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

The goal of this behavioral research study is to learn about the effect of a parent support intervention on cancer patients' and their family caregivers' mental wellbeing, and family functioning.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosed with a metastatic (stage IV) breast, thoracic, gastrointestinal, gynecologic, or genitourinary cancer

With at least one dependent child between the ages of 4 and 17 years and currently living with the parent

ECOG performance status of ≤ 2

With a spousal caregiver/partner who co-parents the child(ren) OR a family caregiver who offers care and support to both the patient and the child(ren) as determined by the patient.

Disqualifiers

Experiences cognitive deficits that would impede the completion of self-report instruments and intervention engagement as deemed by their attending oncologist per medical notes and/or patient not being oriented to time, place and person during the recruitment process

Regularly (self-defined) participation in individual, couple and/or family psychotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Parent Support Intervention

    Behavioral

    Participants will receive one 60 min. session per week for 6 weeks (4 sessions, 240 min. total).

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: CTL: Patients Receive Cancer Treatment Per Usual Care (UC) Control GroupExperimental treatment 1 intervention
Group B: INTERV: Parent - Caregiver Dyads TO The Parent Support InterventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Safety and Adverse Events (AEs)

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame
Through study completion; an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: