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Online and Narrative Interventions for Advanced Cancer Patients

This study is ongoing, but not recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Metastatic Cancer
 Behavioral: My Living Story
Behavioral: My Own Resources

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Online Narrative Interventions and Family Support for Advanced Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Existential Well-being (FACIT-Sp) [ Time Frame: 0, 2 and 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distress (POMS-SF) [ Time Frame: 0, 2, and 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2009
Estimated Study Completion Date: April 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

 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.
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.
 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948207

Locations
United States, Wisconsin
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Margaret (Meg) E Wise, PhD University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00948207     History of Changes
Other Study ID Numbers: R21 CA129890-01A2
Study First Received: July 27, 2009
Last Updated: February 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Metastatic Cancer
Recurrent Cancer
Distributed Hematological Cancer
Advanced Cancer
 Terminal Cancer
Stage III Cancer
Stage IV Cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013