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Breast CancerFOCUS-WEBNCT01415089

Tailored Web-Based Intervention for Cancer Patients and Family Caregivers

A study testing FOCUS-Web in people with Breast Cancer and Colorectal Cancer, run by University of Michigan at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Colorectal Cancer, Lung Cancer
What is being tested?
FOCUS-Web
How many people
63 participants
Where
3 sitesUnited States
Study dates
May 2009to Jun 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

Other trials in United States

About this study

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.

Read the 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.

Being tested
FOCUS-Web
Keywords
Cancer, Quality of life, Family caregiver, Stress and coping, Web-based intervention, Communication
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms, Prostatic Neoplasms, Neoplasms, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FOCUS-WebBehavioural

    Also called FOCUS

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (Time 1) and 2 months (Time 2)

Secondary outcomes (6)

  1. 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.

    Measured: Baseline (Time 1) and 2 months (Time 2)

  2. 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.

    Measured: Baseline (Time 1) and 2 months (Time 2)

  3. 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.

    Measured: Baseline (Time 1) and 2 months (Time 2)

  4. 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.

    Measured: Baseline (Time 1) and 2 months (Time 2)

  5. 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.

    Measured: Baseline (Time 1) and 2 months (Time 2)

  6. Satisfaction with intervention

    An assessment of the patients' and family caregivers' level of satisfaction with the intervention (Process Evaluation) will be conducted.

    Measured: 2 months after baseline survey (Time 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2011 (estimated)
  2. Study startMay 2009
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01415089
Sponsor's protocol ID
R21CA138725
Other IDs
R21CA138725
Acronym
FOCUS-WEB
Status last verified
Oct 2013
First submitted
10 Aug 2011
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21830255

  • 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.

    PubMed 24945270

Questions about this trial

What is this clinical trial studying?

A study testing FOCUS-Web in people with Breast Cancer and Colorectal Cancer, run by University of Michigan at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (time frame: Baseline (Time 1) and 2 months (Time 2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01415089, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.

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