Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

Breast Cancer Clinical Trial

— FOCUS-WEB  

Official title:

Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01415089
• Other study ID #: R21CA138725
• Secondary ID: R21CA138725
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: June 15, 2015
• Start date: May 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Lung Cancer
• Prostate Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (5)

Lead Sponsor	Collaborator
University of Michigan	Barbara Ann Karmanos Cancer Institute, National Cancer Institute (NCI), Saint Joseph Mercy Health System, Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Northouse L, Schafenacker A, Barr KL, Katapodi M, Yoon H, Brittain K, Song L, Ronis DL, An L. A tailored Web-based psychoeducational intervention for cancer patients and their family caregivers. Cancer Nurs. 2014 Sep-Oct;37(5):321-30. doi: 10.1097/NCC.000 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	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.	Baseline (Time 1) and 2 months (Time 2)	No
Secondary	Communication	A preliminary assessment of the magnitude of the pilot intervention effects on patients' and family caregivers' level of communication (MIS Scale) will be conducted.	Baseline (Time 1) and 2 months (Time 2)	No
Secondary	Dyadic support	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.	Baseline (Time 1) and 2 months (Time 2)	No
Secondary	Self-efficacy	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.	Baseline (Time 1) and 2 months (Time 2)	No
Secondary	Perceived benefits of illness	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.	Baseline (Time 1) and 2 months (Time 2)	No
Secondary	Emotional distress	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.	Baseline (Time 1) and 2 months (Time 2)	No
Secondary	Satisfaction with intervention	An assessment of the patients' and family caregivers' level of satisfaction with the intervention (Process Evaluation) will be conducted.	2 months after baseline survey (Time 2)	No