Clinical trial NCT01415089: Tailored Web-Based Intervention for Cancer Patients and Family Caregivers
Official title: Tailored Web-Based Intervention for Cancer Patients and Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Keywords: Cancer
Quality of life
Family caregiver
Stress and coping
Web-based intervention
Communication
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Wayne State University
name: Barbara Ann Karmanos Cancer Institute
name: Saint Joseph Mercy Health System
First posted: 2011-08-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Quality of life
timeFrame: Baseline (Time 1) and 2 months (Time 2)
Secondary outcomes:
measure: Communication
timeFrame: Baseline (Time 1) and 2 months (Time 2)
measure: Dyadic support
timeFrame: Baseline (Time 1) and 2 months (Time 2)
measure: Self-efficacy
timeFrame: Baseline (Time 1) and 2 months (Time 2)
measure: Perceived benefits of illness
timeFrame: Baseline (Time 1) and 2 months (Time 2)
measure: Emotional distress
timeFrame: Baseline (Time 1) and 2 months (Time 2)
measure: Satisfaction with intervention
timeFrame: 2 months after baseline survey (Time 2)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: University of Michigan School of Nursing
name: Laurel Northouse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.