Parenting Support Intervention for Families Coping With an Advanced Cancer Diagnosis
Overview
- Phase
- N/A
- Intervention
- Educational Intervention
- Conditions
- Metastatic Malignant Solid Neoplasm
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers.
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group I (education material, videoconference session)
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).
Intervention: Educational Intervention
Group I (education material, videoconference session)
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).
Intervention: Questionnaire Administration
Group II (waitlist control)
Participants receive standard of care.
Intervention: Best Practice
Group II (waitlist control)
Participants receive standard of care.
Intervention: Questionnaire Administration
Outcomes
Primary Outcomes
Examine the feasibility of implementing a parenting support intervention in 50 patients with an incurable cancer and their spousal caregivers.
Time Frame: Through study completion, an average of 1 year