Breast CancerNCT00679185
Expressive Writing in Improving Quality of Life in Patients With Breast Cancer and Lymphedema
A study testing expressive writing in people with Breast Cancer and Fatigue, run by Vanderbilt University at 3 sites in United States.
Trial summary
RATIONALE: Expressive writing may help relieve symptoms and improve quality of life in breast cancer survivors with chronic lymphedema. PURPOSE: This clinical trial is studying expressive writing in improving the quality of life in women with breast cancer and lymphedema. Read more about this study
- Who is it for?
- Ages 21 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Fatigue, Lymphedema
- What is being tested?
- expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2007to Jan 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 21 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to read, write (for 20 minutes), and speak English
- Willing and able to drive to the study site or agree to be seen in an outpatient setting (e.g., private therapist office, outpatient clinic, physicians office, or own home) once
Who cannot join
- Has medical condition that could cause edema, including any of the following:
- Symptomatic congestive heart failure
- Chronic/acute renal disease
- Cor pulmonale
- Nephrotic syndrome
- Nephrosis
Show all 17Show fewer
- Liver failure
- Cirrhosis
- Pregnant or expect to become pregnant during course of the study
- Unable to stand upright for measurement of height and weight
- Has a metal implant, internal defibrillator, or pacemakers
- History of suicide attempts
- No recent suicidal ideation (within last 6 months)
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent intravenous chemotherapy or radiotherapy for active cancer
- No concurrent antipsychotic medication (i.e., haldol, thorazine, stelazine)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema
RATIONALE: Expressive writing may help relieve symptoms and improve quality of life in breast cancer survivors with chronic lymphedema.
PURPOSE: This clinical trial is studying expressive writing in improving the quality of life in women with breast cancer and lymphedema.
Read the detailed description
OBJECTIVES:
Primary
- To determine if expressive writing improves quality of life (QOL) relative to the control condition in breast cancer survivors with chronic stage II lymphedema.
- To determine if expressive writing improves physical and psychological symptoms/outcomes (i.e., fatigue, psychological distress, activity level, confidence in body) relative to the control condition in breast cancer survivors with chronic lymphedema.
Secondary
- To explore the influence of individual difference variables (dispositional optimism, emotional intelligence, and repressive coping) on outcomes associated with this intervention to include identification of subsets of individuals for whom expressive writing is most effective.
- To explore the influence of intrusive/avoidant thinking as a mediator between the intervention and outcomes of QOL and physical and psychological symptoms.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
Patients travel to the School of Nursing at Vanderbilt University or meet a team member in their home or another private location for an initial visit. Patients complete questionnaires, are measured for height and weight data, and arm fluid measurements.
- Expressive writing group: Twenty minutes a day, twice a week for 2 weeks, patients write about their deepest thoughts and feelings regarding their lymphedema and its treatment.
- Daily diary group (control): Twenty minutes a day, twice a week for 2 weeks patients write about how they manage their time .
Patients complete quality-of-life questionnaires periodically.
After completion of study, patients are followed at 1, 3, and 6 months.
- Conditions
- Breast Cancer, Fatigue, Lymphedema
- Being tested
- expressive writing
- Keywords
- fatigue, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, lymphedema
- Medical subject headings
- Breast Neoplasms, Fatigue, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expressive writingBehavioural
Also called none noted
four non-emotional writing assignments
| Study group | Role | What they receive |
|---|---|---|
| Experimental-EW | Experimental | four emotion focused writing assignments Receives: Behavioral: expressive writing |
| control group | Active comparator | non-emotional writing control Receives: Behavioral: expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical and psychological symptoms
Measured: 6 months
Quality of life
Measured: 6 months
Fatigue
Measured: 6 months
Psychological distress
Measured: 6 months
Activity level
Measured: 6 months
Secondary outcomes (2)
Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms
Measured: baseline study entry
Influence of individual difference variables to discover subsets for treatment effectiveness
Measured: baseline study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2011
- Study completionJan 2011
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 Breast CancerStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sheila Ridner, Vanderbilt University
- Investigators
- Shiela H. Ridner, MSHSA, MSN, PhD, RN, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679185
- Sponsor's protocol ID
- CDR0000587736
- Other IDs
- VU-VICC-SUPP-0422
- Status last verified
- Apr 2017
- First submitted
- 14 May 2008
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ridner SH, Bonner CM, Deng J, Sinclair VG. Voices from the shadows: living with lymphedema. Cancer Nurs. 2012 Jan-Feb;35(1):E18-26. doi: 10.1097/NCC.0b013e31821404c0.
PubMed 21558848
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Expressive Writing in Breast Cancer Survivors With Lymphedema
- ClinicalTrials.gov ID
- NCT00679185
- Acronym / sponsor ID
- CDR0000587736
- Conditions
- Breast Cancer, Fatigue, Lymphedema
- Keywords
- fatigue, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 May 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.
RATIONALE: Expressive writing may help relieve symptoms and improve quality of life in breast cancer survivors with chronic lymphedema.
PURPOSE: This clinical trial is studying expressive writing in improving the quality of life in women with breast cancer and lymphedema.
Detailed description
OBJECTIVES:
Primary
- To determine if expressive writing improves quality of life (QOL) relative to the control condition in breast cancer survivors with chronic stage II lymphedema.
- To determine if expressive writing improves physical and psychological symptoms/outcomes (i.e., fatigue, psychological distress, activity level, confidence in body) relative to the control condition in breast cancer survivors with chronic lymphedema.
Secondary
- To explore the influence of individual difference variables (dispositional optimism, emotional intelligence, and repressive coping) on outcomes associated with this intervention to include identification of subsets of individuals for whom expressive writing is most effective.
- To explore the influence of intrusive/avoidant thinking as a mediator between the intervention and outcomes of QOL and physical and psychological symptoms.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
Patients travel to the School of Nursing at Vanderbilt University or meet a team member in their home or another private location for an initial visit. Patients complete questionnaires, are measured for height and weight data, and arm fluid measurements.
- Expressive writing group: Twenty minutes a day, twice a week for 2 weeks, patients write about their deepest thoughts and feelings regarding their lymphedema and its treatment.
- Daily diary group (control): Twenty minutes a day, twice a week for 2 weeks patients write about how they manage their time .
Patients complete quality-of-life questionnaires periodically.
After completion of study, patients are followed at 1, 3, and 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental-EW | Experimental | Behavioral: expressive writingfour emotion focused writing assignments |
| control group | Active comparator | Behavioral: expressive writingnon-emotional writing control |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to read, write (for 20 minutes), and speak English
- Willing and able to drive to the study site or agree to be seen in an outpatient setting (e.g., private therapist office, outpatient clinic, physicians office, or own home) once
Key exclusion criteria (17 listed)
- Has medical condition that could cause edema, including any of the following:
- Unable to stand upright for measurement of height and weight
- Has a metal implant, internal defibrillator, or pacemakers
- History of suicide attempts
- No recent suicidal ideation (within last 6 months)
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 |
|---|---|---|
| expressive writingAlso: none notedfour non-emotional writing assignments | Behavioural | Experimental-EW, control group |
Primary outcome
Physical and psychological symptoms
Time frame: 6 months
Quality of life
Time frame: 6 months
Fatigue
Time frame: 6 months
Psychological distress
Time frame: 6 months
Activity level
Time frame: 6 months
2 secondary outcomes
Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms
Time frame: baseline study entry
Influence of individual difference variables to discover subsets for treatment effectiveness
Time frame: baseline study entry
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 10 Apr 2017.
- Results publication: PubMed 21558848Ridner SH, Bonner CM, Deng J, Sinclair VG. Voices from the shadows: living with lymphedema. Cancer Nurs. 2012 Jan-Feb;35(1):E18-26. doi: 10.1097/NCC.0b013e31821404c0.
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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.
Shiela H. Ridner, MSHSA, MSN, PhD, RN study chair
Vanderbilt-Ingram Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing expressive writing in people with Breast Cancer and Fatigue, run by Vanderbilt University at 3 sites 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 2 inclusion and 17 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 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Physical and psychological symptoms (time frame: 6 months). The study lists 5 primary outcomes in all. 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 NCT00679185, 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 10 Apr 2017.