Ignite Creation Date:
2024-05-06 @ 3:55 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02409485
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2015-04-01
Brief Title:
Improving Self-Management in Head and Neck Cancer
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Improving Self-Management in Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2020-01
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:
By teaching skills to improve the coordination of care and support in couples coping with head and neck cancer HNC this couple-based psychosocial intervention holds great promise for improving self-management reducing costly hospitalizations and treatment interruptions and improving both partners quality of life Home-based delivery will enhance future dissemination and outreach to those who do not have access to psychosocial services or live far away from their care centers If found effective the intervention may also have salutary downstream effects on the health and well-being of HNC patients and their partners
Detailed Description:
Patients treated with radiation XRT for head and neck cancers HNCs experience significant side effects such as abnormally reduced salivation difficulty swallowing and taste changes even after they have been definitively treated To control side effects and minimize discomfort intensive self-care protocols are prescribed but adherence is poor Partners spousessignificant others can play a critical role in supporting adherence but often lack knowledge experience high rates of distress and display poor communication eg critical or controlling that can interfere with patient self-care The investigators have developed a home-based couples skills-training CST intervention that teaches 1 self-management skills to controlprevent side-effects 2 communication skills to facilitate coordination of care and support and 3 strategies to improve communal coping and confidence in the ability to work as a team The goal is to reduce healthcare utilization and improve multiple domains of patient and partner QOL Specific aims are to develop and evaluate the content and materials of the CST intervention AIM 1 and evaluate its feasibility and acceptability AIM 2 The multidisciplinary team will review and evaluate the content we have already developed based on the ongoing work with HNC couples K07 Once content is finalized tailored manuals will be developed for patients and partners and evaluated through two focus groups AIM 1 The investigators expect that most couples 60 approached will agree to participate and that CST will be well-accepted AIM 2 Knowledge gained will be used to refine CST and to collect data on effect sizes and variation for a larger trial Innovation CST takes a multiple-behavioral approach to addressing and preventing HNC treatment side effects and in the process seeks to improve multiple domains of QOL It is also the first program in HNC that actively involves both members of the couple to address barriers in the home environment in which self-management occurs Finally this study conceptualizes the couple relationship as a resource and leverages that resource to improve patient care and outcomes Impact Home-based delivery will enhance future dissemination and outreach to the target population Overall CST holds great promise for improving patient self-management behaviors reducing costly hospitalizations and treatment interruptions and improving multiple aspects of patient and partner QOL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| R21CA178478 | NIH | None | None |
| H-48778 | OTHER | Baylor College of Medicine | httpsreporternihgovquickSearchR21CA178478 |