NCT00049465

Brief Summary

RATIONALE: Telephone counseling by trained counselors may enhance the well-being and quality of life of patients who have undergone stem cell transplantation for cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of standard follow-up care with extended follow-up care in treating patients who have undergone stem cell transplantation for cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Last Updated

September 21, 2010

Status Verified

September 1, 2010

Enrollment Period

6.5 years

First QC Date

November 12, 2002

Last Update Submit

September 17, 2010

Conditions

Cancer

Keywords

depressionfatiguemenopausal symptomstransitional care planningpsychosocial effects of cancer and its treatmentaccelerated phase chronic myelogenous leukemiachronic idiopathic myelofibrosisblastic phase chronic myelogenous leukemiachronic phase chronic myelogenous leukemiade novo myelodysplastic syndromesdisseminated neuroblastomameningeal chronic myelogenous leukemianoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomaovarian choriocarcinomaovarian embryonal carcinomaovarian yolk sac tumorovarian immature teratomaovarian mature teratomaovarian monodermal and highly specialized teratomaovarian polyembryomaovarian mixed germ cell tumorpoor prognosis metastatic gestational trophoblastic tumorpreviously treated myelodysplastic syndromesrecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Burkitt lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent neuroblastomarecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumorrecurrent malignant testicular germ cell tumorrefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarefractory multiple myelomarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage II ovarian epithelial cancerstage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Burkitt lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III chronic lymphocytic leukemiastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III ovarian epithelial cancerstage III malignant testicular germ cell tumorstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Burkitt lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV breast cancerstage IV chronic lymphocytic leukemiastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV ovarian epithelial cancertesticular choriocarcinoma and embryonal carcinomatesticular choriocarcinoma and seminomatesticular choriocarcinoma and teratomatesticular choriocarcinoma and yolk sac tumortesticular choriocarcinomatesticular embryonal carcinoma and seminomatesticular embryonal carcinoma and teratoma with seminomatesticular embryonal carcinoma and teratomatesticular embryonal carcinoma and yolk sac tumor with seminomatesticular embryonal carcinoma and yolk sac tumortesticular embryonal carcinomatesticular teratomatesticular yolk sac tumor and teratoma with seminomatesticular yolk sac tumor and teratomatesticular yolk sac tumorstage III multiple myelomachronic eosinophilic leukemiachronic neutrophilic leukemiaatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiablenoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage III marginal zone lymphomastage IV small lymphocytic lymphomastage IV marginal zone lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

fatigue assessment and managementPROCEDURE
management of therapy complicationsPROCEDURE
psychosocial assessment and carePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of a malignancy * Planned bone marrow, stem cell, or umbilical cord transplantation after a myeloablative conditioning regimen * Must have completed radiotherapy and conditioning chemotherapy * Must be first stem cell transplantation * Must recover sufficiently, physically and cognitively, to be ambulatory and able to live at home * Must be planning to live with primary caregiver for at least 3 months upon return home * No refractory breast cancer requiring treatment on a phase I protocol PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Must be able to read, write, and communicate well by phone in English * Must not be deaf or blind * Must live in the United States * Must not be too ill or in too much pain * No major psychiatric disorders not in remission * No prisoners * No prior major alcohol or drug abuse * No major cognitive problems * No other concurrent confounding major illness PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Stanford University Medical Center

Stanford, California, 94305-5623, United States

Location

AMC Cancer Research Center

Denver, Colorado, 80214, United States

Location

Rocky Mountain Cancer Centers

Denver, Colorado, 80218, United States

Location

Shands Hospital and Clinics, University of Florida

Gainesville, Florida, 32610-100277, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0914, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84132, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

NeoplasmsDepressionFatigueLeukemia, Myeloid, Accelerated PhasePrimary MyelofibrosisBlast CrisisLeukemia, Myeloid, Chronic-PhasePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeNeuroblastomaCarcinoma, Ovarian EpithelialTesticular NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellMultiple MyelomaBreast NeoplasmsCarcinoma, EmbryonalSeminomaTeratomaEndodermal Sinus TumorTeratoma, TesticularPdgfra-Associated Chronic Eosinophilic LeukemiaLeukemia, Neutrophilic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersLymphoma, B-Cell, Marginal Zone

Interventions

TherapeuticsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSigns and SymptomsPathological Conditions, Signs and SymptomsLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphomaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-CellNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinomaOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesLeukemia, B-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGerminomaMesonephromaMyelodysplastic-Myeloproliferative Diseases

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Karen Syrjala, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

August 1, 1998

Primary Completion

February 1, 2005

Last Updated

September 21, 2010

Record last verified: 2010-09

Locations

US(9)