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Online and Narrative Interventions for Advanced Cancer Patients

Primary Purpose

Metastatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Living Story
My Own Resources
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Cancer focused on measuring Metastatic Cancer, Recurrent Cancer, Distributed Hematological Cancer, Advanced Cancer, Terminal Cancer, Stage III Cancer, Stage IV Cancer

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin Carbone Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

My Living Story

My Own Resources

Arm Description

"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.

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.

Outcomes

Primary Outcome Measures

Existential Well-being (FACIT-Sp)

Secondary Outcome Measures

Distress (POMS-SF)

Full Information

First Posted
July 27, 2009
Last Updated
November 15, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00948207
Brief Title
Online and Narrative Interventions for Advanced Cancer Patients
Official Title
Online Narrative Interventions and Family Support for Advanced Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will test whether narrative life review and web-based social networking for middle aged adults with advanced cancer will improve: existential well being (and reduce psychological distress) generativity and relationship quality, thereby mediating the intervention effects The investigators will also conduct exploratory process analyses of each participant's social network.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
Metastatic Cancer, Recurrent Cancer, Distributed Hematological Cancer, Advanced Cancer, Terminal Cancer, Stage III Cancer, Stage IV Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
My Living Story
Arm Type
Experimental
Arm Description
"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.
Arm Title
My Own Resources
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
My Living Story
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
My Own Resources
Intervention Description
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.
Primary Outcome Measure Information:
Title
Existential Well-being (FACIT-Sp)
Time Frame
0, 2 and 4 months
Secondary Outcome Measure Information:
Title
Distress (POMS-SF)
Time Frame
0, 2, and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret (Meg) E Wise, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu
Description
University of Wisconsin Carbone Cancer Center

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Online and Narrative Interventions for Advanced Cancer Patients

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