| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-SUPP-0422 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
OBJECTIVES:
Primary
Secondary
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.
Patients complete quality-of-life questionnaires periodically.
After completion of study, patients are followed at 1, 3, and 6 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental-EW | Experimental | four emotion focused writing assignments |
|
| control group | Active Comparator | non-emotional writing control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| expressive writing | Behavioral | four non-emotional writing assignments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical and psychological symptoms | 6 months | |
| Quality of life | 6 months | |
| Fatigue | 6 months | |
| Psychological distress | 6 months | |
| Activity level | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of intrusive/avoidant thinking in quality of life and physical or psychological symptoms | baseline study entry | |
| Influence of individual difference variables to discover subsets for treatment effectiveness | baseline study entry |
Not provided
DISEASE CHARACTERISTICS:
Women who have undergone prior surgery and/or radiotherapy for breast cancer
Must have lymphedema, meeting the following conditions:
Stage II disease
Received prior professional treatment for lymphedema
Requires life-long, at home self-care (e.g., compression sleeves)
No history of bilateral lymphedema prohibiting extracellular fluid comparison to an unaffected limb
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
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)
PRIOR CONCURRENT THERAPY:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shiela H. Ridner, MSHSA, MSN, PhD, RN | Vanderbilt-Ingram Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States | ||
| Vanderbilt-Ingram Cancer Center at Franklin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21558848 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D005221 | Fatigue |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nashville |
| Tennessee |
| 37064 |
| United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |