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

This study has been completed.
Sponsor:
Collaborators:
Wayne State University
Barbara Ann Karmanos Cancer Institute
Saint Joseph Mercy Health System
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01415089
First received: August 10, 2011
Last updated: February 10, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Behavioral: FOCUS-Web

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Baseline (Time 1) and 2 months (Time 2) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Communication [ Time Frame: Baseline (Time 1) and 2 months (Time 2) ] [ Designated as safety issue: No ]
    A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of communication (MIS Scale) will be conducted.

  • Dyadic support [ Time Frame: Baseline (Time 1) and 2 months (Time 2) ] [ Designated as safety issue: No ]
    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.

  • Self-efficacy [ Time Frame: Baseline (Time 1) and 2 months (Time 2) ] [ Designated as safety issue: No ]
    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.

  • Perceived benefits of illness [ Time Frame: Baseline (Time 1) and 2 months (Time 2) ] [ Designated as safety issue: No ]
    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.

  • Emotional distress [ Time Frame: Baseline (Time 1) and 2 months (Time 2) ] [ Designated as safety issue: No ]
    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.

  • Satisfaction with intervention [ Time Frame: 2 months after baseline survey (Time 2) ] [ Designated as safety issue: No ]
    An assessment of the patients' and family caregivers' level of satisfaction with the intervention (Process Evaluation) will be conducted.


Enrollment: 63
Study Start Date: May 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: FOCUS-Web
    A 3-session individually tailored, interactive, web-based program providing support and education for cancer patients and one of their family caregivers.
    Other Name: FOCUS
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cancer patients with confirmed diagnosis of breast, colorectal, lung or prostate cancer
  • early stage (I or II, diagnosed within past 2 to 12 months) OR advanced stage (III or IV, diagnosed or progressed within past 2 to 12 months)
  • age 18 or older
  • physically/mentally able to participate
  • speak/read/write English
  • have access to internet at home
  • have a family caregiver willing to participate
  • family caregivers must be age 18 or older, physically/mentally able to participate, able to speak/read/write English, identified by the patient as his or her primarily family caregiver, and have access to and willing to use the internet. "Family caregiver" is defined as the family member or significant other identified by the patient as his or her primary source of emotional or physical support during the current cancer experience and confirmed by the designated individual.

Exclusion Criteria:

  • Family caregivers will be excluded from the study if they themselves have been diagnosed with cancer in the previous year or are receiving active treatment for cancer. This criteria was established so all dyads are managing effects of cancer in patients, not the family caregivers.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415089

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
University of Michigan
Wayne State University
Barbara Ann Karmanos Cancer Institute
Saint Joseph Mercy Health System
Investigators
Principal Investigator: Laurel Northouse, PhD University of Michigan School of Nursing
  More Information

Publications:
Responsible Party: Laurel Northouse PhD, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT01415089     History of Changes
Other Study ID Numbers: R21CA138725, R21CA138725
Study First Received: August 10, 2011
Last Updated: February 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Cancer
Quality of life
Family caregiver
Stress and coping
Web-based intervention
Communication

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014