Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05059678
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2021-09-10
Brief Title:
Parenting Support Intervention for Families Coping With Metastatic or Locally Recurrent Solid Tumor Diagnosis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Parenting Support Intervention for Families Coping With an Advanced Cancer Diagnosis
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mediatorsmoderators 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
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 mediatorsmoderators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-09153 | REGISTRY | None | None |
| 2021-0380 | OTHER | None | None |
| R21CA256694 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchR21CA256694 |