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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00082654 |
Purpose
RATIONALE: Understanding the emotional needs of spouses or others who are living with and caring for patients who have undergone stem cell transplantation may help improve the quality of life of both the caregivers and the patients.
PURPOSE: This clinical trial is studying the emotional needs of caregivers of patients who have undergone stem cell transplant.
| Condition | Intervention |
|---|---|
|
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Ovarian Cancer Psychosocial Effects of Cancer and Its Treatment Testicular Germ Cell Tumor |
Procedure: psychosocial assessment and care |
| Study Type: | Interventional |
| Official Title: | Emotional Needs of Caregivers and Patient/Spouse Couples During Hematopoietic Stem Cell Transplantation (HSCT) |
| Study Start Date: | March 2002 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Caregivers (CG) complete written questionnaires assessing demographics, positive and negative affect, dispositional inhibition, marital satisfaction, and physical health over 45 minutes to 1 hour on day 1. CG then engage in two oral emotional expression exercises (on the topic of caregiving and the transplant) over 2 hours on day 2. Patients are present for one oral emotional expression exercise.
Participants are followed at 2 weeks and 6 months.
PROJECTED ACCRUAL: A total of 60 patient/spouse couples will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
In a marriage OR long-term, committed, heterosexual or homosexual, cohabiting relationship in which one member is post-hematopoietic stem cell transplantation
Patients must meet the following criteria:
At least 1 year since prior first bone marrow, stem cell, or umbilical cord blood transplantation
Spouse/caregiver (CG) must meet the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Principal Investigator: | Shelby Langer, PhD | Fred Hutchinson Cancer Research Center |
More Information
| Study ID Numbers: | FHCRC-1639.00, CDR0000355106 |
| Study First Received: | May 14, 2004 |
| Last Updated: | September 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00082654 History of Changes |
| Health Authority: | United States: Federal Government |
|
psychosocial effects of cancer and its treatment accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission atypical chronic myeloid leukemia blastic phase chronic myelogenous leukemia chronic eosinophilic leukemia chronic idiopathic myelofibrosis chronic myelomonocytic leukemia chronic neutrophilic leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes disseminated neuroblastoma myelodysplastic/myeloproliferative disease, unclassifiable noncontiguous stage II adult Burkitt lymphoma |
noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma poor prognosis metastatic gestational trophoblastic tumor previously treated myelodysplastic syndromes recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma |
|
Neuroectodermal Tumors, Primitive Urogenital Neoplasms Preleukemia Pathologic Processes Neoplasms by Site Hemorrhagic Disorders Cardiovascular Diseases Breast Diseases Endocrine Gland Neoplasms Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myeloproliferative Disorders Genital Neoplasms, Female Breast Neoplasms |
Endocrine System Diseases Multiple Myeloma Neuroectodermal Tumors Neoplasms Gestational Trophoblastic Neoplasms Lymphoma, Non-Hodgkin Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial Pregnancy Complications Precancerous Conditions Blood Protein Disorders Gonadal Disorders Neoplasms, Nerve Tissue Paraproteinemias Ovarian Diseases |
