NCT00679185

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

4 years

First QC Date

May 14, 2008

Last Update Submit

April 7, 2017

Conditions

Breast CancerFatigueLymphedema

Keywords

fatiguestage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerlymphedema

Outcome Measures

Primary Outcomes (5)

  • Physical and psychological symptoms

    6 months

  • Quality of life

    6 months

  • Fatigue

    6 months

  • Psychological distress

    6 months

  • Activity level

    6 months

Secondary Outcomes (2)

  • 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

Study Arms (2)

Experimental-EW

EXPERIMENTAL

four emotion focused writing assignments

Behavioral: expressive writing

control group

ACTIVE COMPARATOR

non-emotional writing control

Behavioral: expressive writing

Interventions

expressive writingBEHAVIORAL

four non-emotional writing assignments

Also known as: none noted
Experimental-EWcontrol group

Eligibility Criteria

Age21 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Related Publications (1)

  • 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.

    PMID: 21558848RESULT

MeSH Terms

Conditions

Breast NeoplasmsFatigueLymphedema

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Shiela H. Ridner, MSHSA, MSN, PhD, RN

    Vanderbilt-Ingram Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

January 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations

US(3)