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Quality of Life in Female Breast Cancer Survivors and Their Spouse, Partner, or Acquaintance

Quality of Life in Younger Breast Cancer Survivors

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00309933
Enrollment
2697
Registered
2006-04-03
Start date
2006-04-03
Completion date
2011-03-31
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Cancer Survivor, Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Sexuality and Reproductive Issues, Spiritual Concerns

Keywords

cognitive/functional effects, spiritual concerns, sexuality and reproductive issues, psychosocial effects of cancer and its treatment, cancer survivor, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Brief summary

RATIONALE: Studying quality of life in breast cancer survivors may help determine the long-term effects of breast cancer and may help improve the quality of life for future breast cancer survivors. PURPOSE: This clinical trial is studying quality of life in female breast cancer survivors and their spouse, partner, or acquaintance.

Detailed description

OBJECTIVES: * Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of female breast cancer survivors who were age 45 or younger at the time of diagnosis with the quality of life of female breast cancer survivors who were age 55 to 70 at time of diagnosis (considering type of surgical treatment \[lumpectomy vs mastectomy\], hormonal treatments, and time since diagnosis as covariates) and age-matched (to the younger group) females with no history of breast cancer. * Compare the quality of life (physical functioning, psychological functioning, social functioning, and spiritual functioning) of partners of breast cancer survivors who were age 45 or younger at time of diagnosis with the quality of life of partners of breast cancer survivors who were age 55 to 70 at diagnosis and partners of age-matched (to the younger group) females with no history of breast cancer. * Test and compare quality of life models that identify the variables that mediate between antecedent variables of personal characteristics, diagnostic and treatment characteristics, and quality of life outcomes in order to determine where interventions to improve quality of life should be targeted. * Explore the relationship of partner antecedent, mediating, and outcome variables as predictors or mediators of outcome variables for breast cancer survivors. OUTLINE: This is a multicenter study. Patients, spouse or partner of patients, age-matched acquaintances of patients, and partner of acquaintances complete questionnaires over 60-90 minutes about personal characteristics, self-efficacy, coping, social support, health care provider communication, physical, psychological, social, and spiritual functioning, and quality of life. After completing the study questionnaires, patients and age-matched acquaintances of patients are interviewed via telephone over 30 minutes for cognitive function assessment. A random subset of patients and spouses/partners of patients are interviewed via telephone over 45-60 minutes, using data-generating and open-ended questions, regarding physical functioning, sexual and reproductive issues, psychological issues, social impact, and methods used to deal with breast cancer survivor concerns. Disease and treatment characteristics of patients are obtained from medical records. PROJECTED ACCRUAL: A total of 2,697 patients, spouse or partner of patients, age-matched female acquaintances of patients, and partner of acquaintances will be accrued for this study.

Interventions

PROCEDUREcognitive assessment
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Eastern Cooperative Oncology Group
Lead SponsorNETWORK

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 78 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Patient * Female breast cancer survivor with age at initial diagnosis in 1 of the following ranges: * 18 to 45 * 55 to 78 * Must have enrolled and participated in ECOG study CLB-9741, E-1199, or E-2197 * Must have received chemotherapy at least 3 years, but no more than 8 years prior to this study entry * Disease free at the time of this study entry * Spouse or partner of the patient, age-matched female acquaintances of the patient (in the younger patient group), or partner of acquaintances * Spouse or partner of the patient may be either gender * Age-matched female acquaintance is defined as within 5 years of age difference of the patient in younger group (18-45 years of age) * With a similar level of education and race of the patient * Not a personal friend of the patient * No history of breast cancer PATIENT CHARACTERISTICS: * Must reside in the continental U.S. and speak English (for patients) PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Design outcomes

Primary

MeasureTime frame
Comparison of the quality of life
Comparison of the quality of life of partners
Comparison of quality of life models
Correlation between partner antecedent, mediating, and outcome variables with patient outcome variables

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026