Breast Cancer, Cancer Survivor, Psychosocial Effects of Cancer and Its Treatment
Conditions
Keywords
psychosocial effects of cancer and its treatment, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, cancer survivor
Brief summary
RATIONALE: Telephone sessions and survivorship booklets may increase knowledge about the psychological and physical impact of breast cancer and increase awareness of available resources. It is not yet known whether survivorship booklets are more effective when given alone or together with individual telephone sessions in informing breast cancer survivors. PURPOSE: This randomized clinical trial is studying individual telephone sessions given together with survivorship booklets compared with survivorship booklets alone to see how well they work in increasing knowledge about the impact of breast cancer in African American and Latina breast cancer survivors.
Detailed description
OBJECTIVES: Primary * Evaluate the utility of individual telephone sessions plus survivorship booklets versus the survivorship booklets alone in increasing knowledge about the psychological and physical impact of breast cancer and increasing awareness of appropriate psychological and medical resources among African American and Latina breast cancer survivors. * Evaluate the utility of these interventions in improving psychological functioning (depression and anxiety) among breast cancer survivors. * Evaluate the utility of these interventions in improving family and social functioning (changes in family and partner communications) among breast cancer survivors. Secondary * Evaluate predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) within and across breast cancer survivors ethnic groups to identify both general and ethnic-specific correlates. OUTLINE: Patients are stratified according to ethnicity (African American vs Latina). Patients are randomized to 1 of 2 groups. * Group 1: Patients receive a survivorship kit of booklets in English or Spanish. Patients then receive a follow-up telephone call at approximately 2 months to clarify any issues relevant to the survivorship kit of booklets. * Group 2: Patients participate in 8 weekly telephone sessions addressing basic breast cancer information; education about psychological and medical effects of cancer and its treatments; resources including psychosocial, medical care facilities, and clinical trials information; stress management and relaxation; cognitive reframing of concerns and behavioral strategies; family communication; relational communication and intimacy; and social support. Patients also receive a survivorship kit of booklets as in group 1. After completion of study intervention, patients complete follow-up questionnaires at 4 to 6 months.
Interventions
BEHAVIORALtelephone-based intervention
Participants receive a Survivorship Kit and telephone sessions based upon responses to initial survey
OTHERcounseling intervention
Participants receive a Survivorship Kit and telephone sessions based upon responses to initial survey
OTHEReducational intervention
Participants receive a Survivorship Kit alone or in combination with telephone sessions based upon responses to initial survey
OTHERquestionnaire administration
Baseline and 9 months after enrollment and intervention
PROCEDUREpsychosocial assessment and care
Participants receive a Survivorship Kit alone or in combination with telephone sessions based upon responses to initial survey
PROCEDUREquality-of-life assessment
Baseline and 9 months after enrollment and intervention
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosed with breast cancer within the past 1-5 years * Stage I-IIIA disease * No metastatic disease PATIENT CHARACTERISTICS: * No other major disabling medical (e.g., another cancer, stroke, heart disease) or psychiatric conditions * Self-identified ethnically as African-American or Latina * Able to read and/or speak English or Spanish * No severe depression or anxiety * History of mild to moderate depression or anxiety allowed * Not pregnant * Not incarcerated PRIOR CONCURRENT THERAPY: * Any type of prior anticancer therapy allowed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increased knowledge about the psychological and physical impact of breast cancer | 9 months post study enrollment |
| Improved psychological functioning (depression and anxiety) | 9 months post study enrollment |
| Improved family and social functioning (changes in family and partner communications) | 9 months post study enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Predictors of health-related quality of life (demographic, medical care factors, psychological, socio-ecological, and socio-cultural factors) | 9 months post study enrollment |
Countries
United States
Outcome results
None listed