Neoplasms

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Respiratory Tract (Lung and Bronchial) Diseases

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Breast Neoplasms

Prostatic Neoplasms

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Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

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Quality of Life

A 3-session individually tailored, interactive, web-based program providing support and education for cancer patients and one of their family caregivers.

FOCUS-Web

Laurel Northouse, PhD

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.

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.

Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of quality of life (FACT-G Scale) will be conducted.

A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of communication (MIS Scale) will be conducted.

A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of dyadic support (Support Scale) will be conducted.

A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of self-efficacy (CASE Scale) will be conducted.

A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of perceived benefits of illness (BOI Scale) will be conducted.

A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of emotional distress (POMS Scale) will be conducted.

An assessment of the patients' and family caregivers' level of satisfaction with the intervention (Process Evaluation) will be conducted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tailored Web-Based Intervention for Cancer Patients and Family Caregivers	NCT01415089	Breast Cancer Colorectal Canc... Lung Cancer Prostate Cancer	FOCUS-Web	18 Years -	University of Michigan
Tailored Web-Based Intervention for Cancer Patients and Family Caregivers	NCT01415089	Breast Cancer Colorectal Canc... Lung Cancer Prostate Cancer	FOCUS-Web	18 Years -	University of Michigan
Tailored Web-Based Intervention for Cancer Patients and Family Caregivers	NCT01415089	Breast Cancer Colorectal Canc... Lung Cancer Prostate Cancer	FOCUS-Web	18 Years -	University of Michigan

Spots Global Cancer Trial Database for stress and coping