Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Online and Narrative Interventions for Advanced Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00948207
First received: July 27, 2009
Last updated: February 10, 2012
Last verified: February 2012

July 27, 2009
February 10, 2012
February 2009
February 2011   (final data collection date for primary outcome measure)
Existential Well-being (FACIT-Sp) [ Time Frame: 0, 2 and 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00948207 on ClinicalTrials.gov Archive Site
Distress (POMS-SF) [ Time Frame: 0, 2, and 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Online and Narrative Interventions for Advanced Cancer Patients
Online Narrative Interventions and Family Support for Advanced Cancer Patients

The investigators will test whether narrative life review and web-based social networking for middle aged adults with advanced cancer will improve:

  1. existential well being (and reduce psychological distress)
  2. generativity and relationship quality, thereby mediating the intervention effects

The investigators will also conduct exploratory process analyses of each participant's social network.

Middle aged patients with advanced cancer report more distress, and active search for meaning and personal growth than older and/or early stage patients. Nonetheless, such positive growth is far from typical and interventions help. Expert-guided life review reduced distress for hospice patients, but is not widely accessible—and many patients lack the energy or skill to write their own life story. Online cancer information and support expert systems improve quality of life. Patients are increasingly developing their own social networks, but many lack the skills to do so. Moreover the effects on social networking on patient well-being have not been studied.

"My Living Story" elicits a dignity-enhancing life story via a telephone interview (based on Chochinov, JAMA 2002), and delivers the edited transcript on the patient's personal miLivingStory social network. miLivingStory links to a life review education website (called miStory) with links to high quality cancer information, support and interactive planning tools.

We hypothesize that telling, revising and sharing the life story with one's selected social network will improve the patient's existential well-being and reduce their distress. Furthermore, we hypothesize that these effects will be mediated by My Living Story's effects on improving the patient's sense of legacy (generativity) and the quality of their relationships. Our exploratory observational analyses of each individual miLivingStory network will contribute to an understanding of how social network configuration and communication patterns correlate with measured outcomes

We will recruit and randomize 100 patients with advanced cancer. The control group will receive a personalized web portal (called miOwnResources) with links to high quality cancer information, social support and interactive planning tools, and a feature to add their own links. All participants will sign informed consent forms, complete a pre-test survey and post-tests at tow and four months.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Metastatic Cancer
  • Behavioral: My Living Story

    Components include:

    1. Life Review Interview by phone (questions based on Chochinov, 2002 dignity enhancing interview);

    2) Edited transcript is delivered in a word format on...;

    3) miLivingStory, a personal social network, where participants can manage content, design and layer; invite and manage their fiends and family.

    4) miStory, a life review education website and portal to websites for: cancer information, databases to "do your own research," social support, interactive planning tools, and a page to add their own weblinks.

  • Behavioral: My Own Resources
    miOwnResources is a personalized, password-protected web portal to high quality websites that provide cancer information, cancer research databases for "do your own research," social support, and interactive planning tools. miOwnResources also has a page for participants to add their own weblinks.
  • Experimental: My Living Story

    "My Living Story" elicits a dignity-enhancing life story via a telephone interview, and delivers the edited transcript on the patient's personal miLivingStory social network. miLivingStory also provides a direct link to miStory, a life review education website with links to high quality websites that provide cancer information, databases to "do your own research", social support, interactive planning tools, and a page to add their own weblinks.

    miLivingStory and miStory are both password protected.

    Intervention: Behavioral: My Living Story
  • Active Comparator: My Own Resources
    My Own Resources offers usual care access to high quality websites that provide cancer information, databases to "do your own research," social support, and interactive planning tools. Participants will receive access to the website miOwnResources.
    Interventions:
    • Behavioral: My Living Story
    • Behavioral: My Own Resources
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
April 2012
February 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 30 - 60,
  • Stage III or IV Cancer,
  • Able and willing to use an internet computer to complete study activities.

Exclusion Criteria:

  • Institutionalized, < 6 months prognosis,
  • Cannot read or understand English,
  • Unable or unwilling to use an internet computer to complete study activities.
Both
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00948207
R21 CA129890-01A2
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Margaret (Meg) E Wise, PhD University of Wisconsin, Madison
University of Wisconsin, Madison
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP