Tailored Web-Based Intervention for Cancer Patients and Family Caregivers (FOCUS-WEB)
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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 |
- 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.
- 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) |
-
Behavioral: FOCUS-Web
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 |
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| 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 | |
| Principal Investigator: | Laurel Northouse, PhD | University of Michigan School of Nursing |
More Information
No publications provided
| 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: | August 10, 2011 |
| 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 May 21, 2013