Educational Program in Younger Women Who Have Recently Finished Treatment for Stage I or Stage II Breast Cancer

Carnegie Mellon University

Status: Completed

Conditions: Breast Neoplasms

Treatments: Behavioral: Education Intervention; Behavioral: Nutrition Education Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00416572

5R01CA064711 (U.S. NIH Grant/Contract)

CMU-00000603

Details and patient eligibility

About

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.

Full 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.

Enrollment: 252 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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252 participants in 3 patient groups

Education Intervention

Experimental group

Description:

Participants attended 4 2-hr education sessions. The overall goal of the sessions was to provide information that would reduce participants' uncertainty about their illness and its treatment, to enhance coping in productive ways with the issues and problems confronting them, and to facilitate communication between the participants and their partners.

Treatment:

Behavioral: Education Intervention

Nutrition Education Intervention

Experimental group

Description:

Participants attended 4 2-hr nutrition education sessions. Each session provided information and encouragement on setting and attaining measurable goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems in life and living a healthy lifestyle.

Treatment:

Behavioral: Nutrition Education Intervention

Control Condition

No Intervention group

Description:

Participants received care as usual.