Metastatic CancerNCT00948207
Online and Narrative Interventions for Advanced Cancer Patients
A study testing My Living Story and My Own Resources in people with Metastatic Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- My Living Story and My Own Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jul 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 30 - 60,
- Stage III or IV Cancer,
- Able and willing to use an internet computer to complete study activities.
Who cannot join
- Institutionalized, < 6 months prognosis,
- Cannot read or understand English,
- Unable or unwilling to use an internet computer to complete study activities.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: 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:
- 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.
Read the 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.
- Conditions
- Metastatic Cancer
- Being tested
- My Living Story, My Own Resources
- Keywords
- Metastatic Cancer, Recurrent Cancer, Distributed Hematological Cancer, Advanced Cancer, Terminal Cancer, Stage III Cancer, Stage IV Cancer
- Medical subject headings
- Neoplasm Metastasis, Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Living StoryBehavioural
Components include:
- Life Review Interview by phone (questions based on Chochinov, 2002 dignity enhancing interview);
- Edited transcript is delivered in a word format on...;
- miLivingStory, a personal social network, where participants can manage content, design and layer; invite and manage their fiends and family.
- 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.
My Own ResourcesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| My Living Story | Experimental | "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. Receives: Behavioral: My Living Story |
| My Own Resources | Active comparator | 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. Receives: Behavioral: My Living Story; Behavioral: My Own Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Existential Well-being (FACIT-Sp)
Measured: 0, 2 and 4 months
Secondary outcomes (1)
Distress (POMS-SF)
Measured: 0, 2, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Margaret (Meg) E Wise, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00948207
- Sponsor's protocol ID
- M-2009-1189
- Other IDs
- R21CA129890-01A2, CC09310, M-2009-1189, A568000, PHARM/SRC
- Status last verified
- Feb 2016
- First submitted
- 27 Jul 2009
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Narrative Interventions and Family Support for Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT00948207
- Acronym / sponsor ID
- M-2009-1189
- Conditions
- Metastatic Cancer
- Keywords
- Metastatic Cancer, Recurrent Cancer, Distributed Hematological Cancer, Advanced Cancer, Terminal Cancer, Stage III Cancer, Stage IV Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 29 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My Living Story | Experimental | Behavioral: 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. |
| My Own Resources | Active comparator | Behavioral: My Living Story, Behavioral: My Own ResourcesMy 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. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 30 - 60,
- Stage III or IV Cancer,
- Able and willing to use an internet computer to complete study activities.
Key exclusion criteria (3 listed)
- Institutionalized, < 6 months prognosis,
- Cannot read or understand English,
- Unable or unwilling to use an internet computer to complete study activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Living StoryComponents 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. | Behavioural | My Living Story, My Own Resources |
| My Own ResourcesmiOwnResources 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. | Behavioural | My Own Resources |
Primary outcome
Existential Well-being (FACIT-Sp)
Time frame: 0, 2 and 4 months
1 secondary outcome
Distress (POMS-SF)
Time frame: 0, 2, and 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret (Meg) E Wise, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Living Story and My Own Resources in people with Metastatic Cancer, run by University of Wisconsin, Madison at 1 site 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 3 inclusion and 3 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Existential Well-being (FACIT-Sp) (time frame: 0, 2 and 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.