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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

August 10, 2011
February 10, 2014
May 2009
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01415089 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Tailored Web-Based Intervention for Cancer Patients and Family Caregivers
Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
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
Not Provided
Zulman DM, Schafenacker A, Barr KL, Moore IT, Fisher J, McCurdy K, Derry HA, Saunders EW, An LC, Northouse L. Adapting an in-person patient-caregiver communication intervention to a tailored web-based format. Psychooncology. 2012 Mar;21(3):336-41. doi: 10.1002/pon.1900. Epub 2011 Jan 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01415089
R21CA138725, R21CA138725
Yes
Laurel Northouse PhD, Principal Investigator, University of Michigan
University of Michigan
  • National Cancer Institute (NCI)
  • Wayne State University
  • Barbara Ann Karmanos Cancer Institute
  • Saint Joseph Mercy Health System
Principal Investigator: Laurel Northouse, PhD University of Michigan School of Nursing
University of Michigan
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP