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

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Trial Identification

Brief Title: 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 ID: NCT00416572

Study Description

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

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Name: Michael Scheier, PhD

Affiliation: Pittsburgh Mind-Body Center at Carnegie Mellon University

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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