M D Anderson Cancer Center
Houston, Texas, 77030, United States
Location status: Recruiting
NCT Number: NCT05059678
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receive standard of care
Other names: standard of care, standard therapy
Receive educational materials and attend videoconference sessions
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Ancillary studies
Time frame: Through study completion, an average of 1 year
Contact information is provided by the study sponsor or research team.
M.D. Anderson Cancer Center
Other
Parenting Support Intervention for Families Coping With an Advanced Cancer Diagnosis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05564377
Adnexal Diseases, Advanced Malignant Solid Neoplasm
Birmingham, Alabama, United States
View Trial DetailsNCT06320405
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Portland, Oregon, United States
View Trial DetailsNCT06223542
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Bethesda, Maryland, United States
View Trial DetailsNCT04119024
Acral Melanoma, Adenocarcinoma
Duarte, California, United States
View Trial Details