Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

NCT ID: NCT01415089

Last Updated: 2015-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-06-30

Brief 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.

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.

Conditions

Breast Cancer; Colorectal Cancer; Lung Cancer; Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

FOCUS-Web

A 3-session individually tailored, interactive, web-based program providing support and education for cancer patients and one of their family caregivers.

Intervention Type: BEHAVIORAL

Other Intervention Names

FOCUS

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wayne State University

OTHER

Sponsor Role: collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role: collaborator

Trinity Health Michigan

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

University of Michigan

Principal Investigators

Laurel Northouse, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Nursing

Locations

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, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21830255 (View on PubMed)

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.0000000000000159.

Reference Type: RESULT

PMID: 24945270 (View on PubMed)

Other Identifiers

R21CA138725

Identifier Type: NIH

Identifier Source: secondary_id

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R21CA138725

Identifier Type: NIH

Identifier Source: org_study_id

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