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Completed

NCT Number: NCT00799461

Internet-Based Program With or Without Telephone-Based Problem-Solving Training in Helping Long-Term Survivors of Hematopoietic Stem Cell Transplant Cope With Late Complications

RATIONALE: A personalized Internet-based program may help improve fatigue, depression, and quality of life in long-term survivors of stem cell transplant. It is not yet known whether an Internet-based program is more effective with or without telephone-based problem-solving training.

PURPOSE: This randomized clinical trial is studying how well an Internet-based program works with or without telephone-based problem-solving training in helping long-term survivors of hematopoietic stem cell transplant cope with late complications

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Key information

Conditions

Accelerated Phase Chronic Myelogenous Leukemia Adult Acute Lymphoblastic Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myeloid Leukemia in Remission Atypical Chronic Myeloid Leukemia, BCR-ABL Negative Behavior Behavioral Symptoms Blast Crisis Blastic Phase Chronic Myelogenous Leukemia Blood Protein Disorders Bone Marrow Diseases Burkitt Lymphoma Cancer Survivor Carcinogenesis Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Chronic Eosinophilic Leukemia Chronic Myelomonocytic Leukemia Chronic Neutrophilic Leukemia Chronic Phase Chronic Myelogenous Leukemia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Depression Disease Attributes Disseminated Neuroblastoma Epstein-Barr Virus Infections Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Neutrophilic, Chronic Long-term Effects Secondary to Cancer Therapy in Adults Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Multiple Myeloma Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Neoplastic Processes Nodal Marginal Zone B-cell Lymphoma 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 Noncontiguous Stage II Marginal Zone Lymphoma Noncontiguous Stage II Small Lymphocytic Lymphoma Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Pdgfra-Associated Chronic Eosinophilic Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Previously Treated Myelodysplastic Syndromes Primary Myelofibrosis Psychosocial Effects of Cancer and Its Treatment Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Signs and Symptoms Splenic Marginal Zone Lymphoma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Adult Burkitt Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Mixed Cell Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult Hodgkin Lymphoma Stage III Adult Immunoblastic Large Cell Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Chronic Lymphocytic Leukemia Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage III Marginal Zone Lymphoma Stage III Multiple Myeloma Stage III Small Lymphocytic Lymphoma Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Hodgkin Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Chronic Lymphocytic Leukemia Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Small Lymphocytic Lymphoma Tumor Virus Infections Vascular Diseases Virus Diseases de Novo Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

OBJECTIVES:

I. To determine the efficacy of a randomized controlled trial to improve long term fatigue/physical dysfunction, depression/distress and health surveillance behaviors in adult 3 to 25-year hematopoietic stem cell transplant (HSCT) survivors using an internet only or internet and phone-based problem-solving and activation training compared with survivors randomized to a delayed internet access control.

II. To determine the reach, utilization, and implementation costs of a web-based, individually tailored intervention, disseminated through widely used patient information websites, targeting a national cohort of adult 2-25 year HSCT survivors. (Phase III/IV) III. To determine, in a randomized controlled trial, the efficacy of a nationally disseminated, internet-based, individually tailored intervention to improve long-term fatigue, distress and health promotion behaviors in HSCT survivors, compared with survivors randomized to a delayed internet access control. (Phase III/IV)

OUTLINE: Patients with elevated fatigue, depression, and/or distress at baseline are randomized to 1 of 3 arms (ARMS I, II, or III). Patients without elevated fatigue, depression or distress at baseline are randomized to 1 of 2 arms (ARMS II or III).

ARM I (FULL WEBSITE ACCESS WITH PROBLEM-SOLVING TRAINING [PST]; FIRST STUDY ONLY; CLOSED TO ACCRUAL): Patients receive full access to INSPIRE website for 6 months, which offers an individually tailored greeting home page with links to information on each of the target areas identified as being elevated on baseline assessment and how to manage the complications; a bulletin board with input from other survivors that is solicited, edited, and posted weekly; resource pages; and an opportunity to send secure messages with questions or comments. Patients also undergo 4-8 phone-based PST sessions with a behavioral health specialist.

ARM II (FULL WEBSITE ACCESS WITHOUT PST): Patients receive full access to INSPIRE website for 6 months as in ARM I.

ARM III (DELAYED WEBSITE ACCESS): Patients do not have access to INSPIRE website for 6 months. After 6 months, patients receive full access to INSPIRE website for 3 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hematopoietic stem cell transplant recipient between 3-25 years since last transplant
  • Hematopoietic stem cell transplant recipient > = 2 years since last transplant (second, phase III/IV study only)
  • Any type of transplant (autologous, allogeneic, myeloablative, non-myeloablative, marrow or peripheral blood stem cells)
  • Able to communicate in English as indicated by ability to communicate adequately with study staff to participate in the clinical phone calls and to complete patient-reported outcomes (PRO) assessments in English
  • Has internet and email access (indicated by logon to site for consent and assessment)

Exclusion criteria

  • Does not complete the baseline assessment through the HADS (Hospital Anxiety and Depression Scale)
  • Does not complete required assessments in the background and medical history forms required to determine whether meet inclusion and exclusion criteria, stratification, sample description, or primary outcomes (includes age, gender, ethnicity, race, transplant site, and medical information about transplant if not FHCRC or SCCA patient, education, work, height and weight, current medications
  • Survivors who score 3.0 or above on the SCL depression measure (indicating severe depression) or who report moderate to severe suicidal ideation will be ineligible for randomization; these survivors will, however, have full access to the website if they have completed the required baseline assessment; they will be asked to also complete follow-up assessments
  • Survivors who report to us that they have been in active treatment for relapse of their original disease, or for a second cancer, in the past 2 years will be ineligible for randomization, unless the second cancer was treated only with surgical removal (e.g., basal, squamous or localized melanoma skin cancer, or breast ductal carcinoma in situ [DCIS])
  • These survivors will, however, have full access to the website if they have completed the required baseline assessment; they will be asked to also complete follow-up assessments

Treatment and study plan

Internet-Based Intervention

Other

Delayed access to online educational information and resources for managing long term complications of hematopoietic cell transplantation

Questionnaire Administration

Other

Completion of questions in an online format

psychosocial assessment and care

Procedure

Assessment and care of psychosocial aspects

Other names: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment, psychosocial studies

assessment of therapy complications

Procedure

Evaluation of complications of treatment

management of therapy complications

Procedure

Managing therapy complications

Other names: complications of therapy, management of

fatigue assessment and management

Procedure

Assessing and managing fatigue

Other names: fatigue assessment/management

counseling intervention

Other

Counseling provided via telephone

Other names: counseling and communications studies

Primary outcomes

  1. Aggregate number of targeted problems

    Time frame: At 6 months

  2. Reach of web-based intervention (second, phase III/IV study only)

    Time frame: At 6 months

    As indicated by proportion logging on the website content for males (targeting 50%), older (targeting 50% over age 55), and geographically underserved participants (targeting 20% rural residents as indicated by zip code), as well as percent who logon to the study website content after initially registering for the study (targeting 90%) second

  3. Utilization of web-based intervention (second, phase III/IV study only)

    Time frame: At 6 months

    As indicated by number of pages viewed (targeting a mean of 10), log-on times (targeting a mean of 2) and time from notification of website content access to website content logon (targeting a mean of 2 weeks)

  4. Satisfaction, use and barriers ratings at the end of the study including barriers to website use and barriers to using health promotion guidelines (second, phase III/IV study only)

    Time frame: At 6 months

  5. Cost to maintain the site content (not including costs for maintenance of the assessment process) (second, phase III/IV study only)

    Time frame: At 6 months

    As indicated by per participant prorated costs for materials and time for updating content, responding to participant comments and requests, maintaining programming and responding to technical problems

Secondary outcomes

  1. Mean z score combining the Vitality and Physical Function subscales of the SF-36

    Time frame: At 6 months

  2. Mean z score combining the Symptom Checklist 90-R Depression scale and the Cancer and Treatment Distress - Uncertainty subscale

    Time frame: At 6 months

  3. Total health care utilization behaviors

    Time frame: At 6 months

  4. Long-term fatigue and distress of survivors compared with controls (second, phase III/IV study only)

    Time frame: At 6 months

  5. Long-term health promotion of survivors compared with controls (second, phase III/IV study only)

    Time frame: At 6 months

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

INSPIRE: An Internet-based RCT for Long-term Survivors of Hematopoietic Stem Cell Transplantation

Important dates

Study start
2008
Primary completion
2011
First posted
Nov 27, 2008
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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