Ignite Creation Date:
2024-05-05 @ 11:47 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01415089
Status:
COMPLETED
Last Update Posted:
2015-06-16
First Post:
2011-08-10
Brief Title:
Tailored Web-Based Intervention for Cancer Patients and Family Caregivers
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Tailored Web-Based Intervention for Cancer Patients and Family Caregivers
Status:
COMPLETED
Status Verified Date:
2013-10
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:
FOCUS-WEB
Brief Summary:
The purpose of this pilot study is to develop a personalized interactive and web-based module for cancer patients and a family caregiver The three-session module will be designed to help patients and family caregivers improve their communication and support
Detailed Description:
This R21 will be used to develop an individually tailored interactive web-based intervention for cancer patients lung colorectal breast prostate and their family caregivers This intervention is based on an efficacious family-based program of care the FOCUS Program that has been tested previously in three large randomized clinical trials with positive outcomes for patients and their caregivers In this R21 we will translate this primarily face-to-face family-based program to an internet-based version
The objectives are Objective 1 To develop an individually-tailored interactive web-based and email-based Family Involvement Module We will conduct formative testing while developing the module using qualitative data obtained from four focus groups We will conduct usability testing of the near final module with data obtained from qualitative interviews with patients and caregivers as they complete web-based task assignments using a think aloud protocol while they navigate the module Objective 2 To conduct a Phase II study with cancer patients and their family caregiver N 40 dyads using baseline Time 1 and two-month follow-up assessments Time 2 Between Times 1 and 2 all participants jointly will complete the web-based Family Involvement Module We will determine the feasibility of delivering the web-based module and will obtain a process evaluation completed by study participants Data will be obtained from three large cancer centers using established instruments and analyzed with descriptive statistics and paired t-tests Findings from this R21 will provide data that are essential to test this innovative tailored interactive web-based intervention with a larger sample in a R01
The objectives are Objective 1 To develop an individually-tailored interactive web-based and email-based Family Involvement Module We will conduct formative testing while developing the module using qualitative data obtained from four focus groups We will conduct usability testing of the near final module with data obtained from qualitative interviews with patients and caregivers as they complete web-based task assignments using a think aloud protocol while they navigate the module Objective 2 To conduct a Phase II study with cancer patients and their family caregiver N 40 dyads using baseline Time 1 and two-month follow-up assessments Time 2 Between Times 1 and 2 all participants jointly will complete the web-based Family Involvement Module We will determine the feasibility of delivering the web-based module and will obtain a process evaluation completed by study participants Data will be obtained from three large cancer centers using established instruments and analyzed with descriptive statistics and paired t-tests Findings from this R21 will provide data that are essential to test this innovative tailored interactive web-based intervention with a larger sample in a R01
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 |
|---|---|---|---|
| R21CA138725 | NIH | None | httpsreporternihgovquickSearchR21CA138725 |