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Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

18 Years
Not Enrolling
Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer

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Trial Information

Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

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.

Inclusion Criteria:

- cancer patients with confirmed diagnosis of breast, colorectal, lung or prostate

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Quality of life

Outcome Description:

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.

Outcome Time Frame:

Baseline (Time 1) and 2 months (Time 2)

Safety Issue:


Principal Investigator

Laurel Northouse, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan School of Nursing


United States: Institutional Review Board

Study ID:




Start Date:

May 2009

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
  • Cancer
  • Quality of life
  • Family caregiver
  • Stress and coping
  • Web-based intervention
  • Communication
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Lung Neoplasms
  • Prostatic Neoplasms



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Saint Joseph Mercy Hospital Ann Arbor, Michigan  48106