Metastatic Breast CancerNCT00624156
Expressive Writing and Adjustment to Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
We are doing this study to see if writing about life experiences helps women adjust to breast cancer that has spread. We will compare two groups. One group will write about their breast cancer experience. The other will write about their daily activities. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Writing Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jan 2012
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: MSKCC clinics
Who may be able to join
- Women with Stage IV breast cancer
- Receiving cancer care at Memorial Sloan-Kettering Cancer Center
- At least 18 years of age
- Can speak, read, and write in English
- In the judgment of consenting professionals able to provide informed consent
- Score of 4 or higher on the distress thermometer (established cutoff score for probable distress; see Jacobsen et al., 2005)
Who cannot join
- Significant psychiatric or cognitive impairment (dementia/delirium, retardation, psychosis) that in the judgment of the investigators will preclude providing informed consent and participating in the intervention
- Currently engaging in expressive writing (e.g., journal writing that involves expressing one's feelings) on a daily basis
- Currently participating in intervention trials with similar endpoints • Male
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
We are doing this study to see if writing about life experiences helps women adjust to breast cancer that has spread. We will compare two groups. One group will write about their breast cancer experience. The other will write about their daily activities. What we learn from this study may help us to find new ways to help women cope with breast cancer that has spread.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Writing Intervention
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Writing InterventionBehavioural
Also called Over four sessions, I want you to write about your experience with cancer. In your writing, I, want you to really let go and explore your very deepest emotions and thoughts. It is critical that you, delve deeply.
Participants in the emotional disclosure condition will be instructed to write continuously for 20 minutes about their deepest thoughts and feelings regarding their cancer experience.
Writing InterventionBehavioural
Also called Over four sessions, I want you to write about how you use your time. I am interested in, everything you do during the course of a day. I realize that you experience many emotions, but in, your writing I want you to focus only on the facts, not on your emotions.
Participants assigned to the control condition will be instructed to describe in a detailed, nonemotional manner their daily activities. The 20-minute writing task will be introduced as a time management intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | emotional disclosure writing intervention Receives: Behavioral: Writing Intervention | |
| 2 | control writing Receives: Behavioral: Writing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the potential utility of expressive writing for enhancing existential well-being (i.e., increasing a sense of meaning and peace and reducing demoralization) among women with metastatic breast cancer.
Measured: conclusion of the study
Secondary outcomes (1)
Determine the potential utility of expressive writing for reducing distress (i.e., depressive symptoms, anxiety, cancer-specific and general distress) among women with metastatic breast cancer.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Indiana University
- Responsible party
- Sponsor
- Investigators
- Katherine DuHamel, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624156
- Sponsor's protocol ID
- 08-011
- Status last verified
- Oct 2015
- First submitted
- 15 Feb 2008
- Last updated
- 30 Oct 2015
- Results posted
- No
Publications
Mosher CE, Duhamel KN, Lam J, Dickler M, Li Y, Massie MJ, Norton L. Randomised trial of expressive writing for distressed metastatic breast cancer patients. Psychol Health. 2012;27(1):88-100. doi: 10.1080/08870446.2010.551212. Epub 2011 Jul 8.
PubMed 21678181
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing and Adjustment to Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00624156
- Acronym / sponsor ID
- 08-011
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Indiana University
- Study start
- Feb 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Feb 2008 (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.
We are doing this study to see if writing about life experiences helps women adjust to breast cancer that has spread. We will compare two groups. One group will write about their breast cancer experience. The other will write about their daily activities. What we learn from this study may help us to find new ways to help women cope with breast cancer that has spread.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Writing Interventionemotional disclosure writing intervention |
| 2 | – | Behavioral: Writing Interventioncontrol writing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinics
Key inclusion criteria (6 listed)
- Women with Stage IV breast cancer
- Receiving cancer care at Memorial Sloan-Kettering Cancer Center
- At least 18 years of age
- Can speak, read, and write in English
- In the judgment of consenting professionals able to provide informed consent
Key exclusion criteria (3 listed)
- Significant psychiatric or cognitive impairment (dementia/delirium, retardation, psychosis) that in the judgment of the investigators will preclude providing informed consent and participating in the intervention
- Currently engaging in expressive writing (e.g., journal writing that involves expressing one's feelings) on a daily basis
- Currently participating in intervention trials with similar endpoints • Male
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 |
|---|---|---|
| Writing InterventionAlso: Over four sessions, I want you to write about your experience with cancer. In your writing, I, want you to really let go and explore your very deepest emotions and thoughts. It is critical that you, delve deeply.Participants in the emotional disclosure condition will be instructed to write continuously for 20 minutes about their deepest thoughts and feelings regarding their cancer experience. | Behavioural | 1 |
| Writing InterventionAlso: Over four sessions, I want you to write about how you use your time. I am interested in, everything you do during the course of a day. I realize that you experience many emotions, but in, your writing I want you to focus only on the facts, not on your emotions.Participants assigned to the control condition will be instructed to describe in a detailed, nonemotional manner their daily activities. The 20-minute writing task will be introduced as a time management intervention | Behavioural | 2 |
Primary outcome
Determine the potential utility of expressive writing for enhancing existential well-being (i.e., increasing a sense of meaning and peace and reducing demoralization) among women with metastatic breast cancer.
Time frame: conclusion of the study
1 secondary outcome
Determine the potential utility of expressive writing for reducing distress (i.e., depressive symptoms, anxiety, cancer-specific and general distress) among women with metastatic breast cancer.
Time frame: conclusion of the study
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 30 Oct 2015.
- Derived from this study: PubMed 21678181Mosher CE, Duhamel KN, Lam J, Dickler M, Li Y, Massie MJ, Norton L. Randomised trial of expressive writing for distressed metastatic breast cancer patients. Psychol Health. 2012;27(1):88-100. doi: 10.1080/08870446.2010.551212. Epub 2011 Jul 8.
- Memorial Sloan-Kettering 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.
Katherine DuHamel, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Memorial Sloan Kettering Cancer Center 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 6 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 30 Oct 2015. 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?
Determine the potential utility of expressive writing for enhancing existential well-being (i.e., increasing a sense of meaning and peace and reducing demoralization) among women with metastatic breast cancer. (time frame: conclusion of the study). 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 NCT00624156, which also lists 1 linked publication.
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 30 Oct 2015.