Clinical trial NCT00416572: Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer
Official title: Adjustment to Breast Cancer Among Younger Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: psychosocial effects of cancer and its treatment
stage I breast cancer
stage II breast cancer
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-12-28
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: RATIONALE: Educational programs may improve coping and quality of life in younger women who have recently been treated for early-stage breast cancer.

PURPOSE: To conduct a clinical trial to determine if an educational intervention and a nutritional intervention could enhance physical and psychological functioning among younger women completing treatment for early-stage breast cancer.

Detailed description: OBJECTIVES:

* Design, implement, and evaluate an educational intervention and a nutrition education intervention specifically aimed at improving adjustment among younger women who have been newly diagnosed with and treated for stage I or II breast cancer and who are ending the active phase of treatment.
* Determine the processes through which the interventions affect quality of life.
* Assess whether the interventions are differentially effective for different groups of women.
* Determine how women who decline participation differ from those who participate.
* Determine the nature and extent of adjustment difficulties, using baseline data, in younger women living in an urban setting who have been treated for early stage breast cancer.
* Identify personality and situational correlates of individuals who adapt well to early-stage breast cancer diagnosis and treatment and those who do not.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 intervention groups or a control condition.

* Arm I (control group): Patients did not undergo any intervention. Patients were evaluated at baseline and at 4 and 13 months.
* Arm II (breast cancer education group): Patients attended a series of approximately 2-hour-long breast cancer education group sessions once a month for 4 months. Sessions involved the presentation of information concerning breast cancer, followed by a guided discussion of related topics. Sessions topics included: talking with children about cancer, life after diagnosis, relationships/intimacy, and hormones and breast cancer/basic factors of heredity. Patients were also given booklets and brochures to read at home. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention.
* Arm III (nutritional education group): Patients attended a series of approximately 2-hour-long nutritional education group sessions once a month for 4 months. Sessions involved the presentation of information concerning nutrition, followed by a guided discussion of related topics. Session topics included: healthy cupboards, what's cooking, shopping for success, and out on the town. Patients were also asked to keep a 4 day record of diet. Patients were evaluated at baseline, immediately after the intervention, and at 9 months after the intervention.

Eligibility criteria: INCLUSION CRITERIA (Disease Characteristics):

* Diagnosis of breast cancer

  * Stage I or II disease
  * No more than 10 positive lymph nodes
  * First-time diagnosis
  * Under the age of 50 at diagnosis
* Finished active treatment within the past 2 months
* English-speaking only
* Must live within 30 miles of Magee Women's Hospital, Pittsburgh, Pennsylvania

INCLUSION CRITERIA (Patient Characteristics):

* Female patients only
* Must be able to communicate

EXCLUSION CRITERIA (Patient Characteristics):

* Other prior malignancies except skin cancer

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Depressive Symptoms (Measured With an Abbreviated 10-item CES-D) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention).
timeFrame: Baseline, Post-intervention(4 months post-intervention) and Final Follow-up(13 months post-intervention).
measure: Perceived Physical Health (Measured With SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
timeFrame: Baseline, Post-intervention(4 months post-intervention), and Final Follow-up(13 months post-intervention)
measure: Mental Health (Measured With the SF-36) at Baseline, Post-intervention (4-months Post-intervention) and Final Follow-up (13-months Post-intervention)
timeFrame: Baseline, Post-intervention(4 months post-intervention), Final Follow-up(13 months post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pittsburgh Mind-Body Center at Carnegie Mellon University
name: Michael Scheier, PhD
role: STUDY_CHAIR
References: