Tailored Web-Based Intervention for Cancer Patients & Family Caregivers

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01415089
Study type	Interventional
Source	University of Michigan
Contact
Status	Completed
Phase	N/A
Start date	May 2009
Completion date	June 2011

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Tailored Web-Based Intervention for Cancer Patients and Family Caregivers — FOCUS-WEB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms