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

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Status and phase: Completed; Phase 3

Conditions: Stage IV Small Lymphocytic Lymphoma; Stage III Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Chronic Neutrophilic Leukemia; Splenic Marginal Zone Lymphoma; Chronic Eosinophilic Leukemia; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Adult Acute Myeloid Leukemia in Remission; Noncontiguous Stage II Mantle Cell Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Marginal Zone Lymphoma; Fatigue; Stage III Grade 3 Follicular Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Recurrent Mantle Cell Lymphoma; Stage I Multiple Myeloma; Blastic Phase Chronic Myelogenous Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage III Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Chronic Myelomonocytic Leukemia; Stage III Adult Immunoblastic Large Cell Lymphoma; Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Stage III Adult Diffuse Large Cell Lymphoma; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Recurrent Small Lymphocytic Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Accelerated Phase Chronic Myelogenous Leukemia; Nodal Marginal Zone B-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Long-term Effects Secondary to Cancer Therapy in Adults; Stage III Multiple Myeloma; Stage III Marginal Zone Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Chronic Phase Chronic Myelogenous Leukemia; Depression; Refractory Hairy Cell Leukemia; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Recurrent Adult Hodgkin Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Refractory Multiple Myeloma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Previously Treated Myelodysplastic Syndromes; Cancer Survivor; Relapsing Chronic Myelogenous Leukemia; Recurrent Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; de Novo Myelodysplastic Syndromes; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Stage IV Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Adult Acute Lymphoblastic Leukemia in Remission; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Secondary Myelodysplastic Syndromes; Disseminated Neuroblastoma; Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Noncontiguous Stage II Grade 3 Follicular Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Mantle Cell Lymphoma; Primary Myelofibrosis; Stage IV Chronic Lymphocytic Leukemia; Secondary Acute Myeloid Leukemia; Recurrent Adult Acute Myeloid Leukemia; Psychosocial Effects of Cancer and Its Treatment; Atypical Chronic Myeloid Leukemia, BCR-ABL Negative; Stage IV Grade 1 Follicular Lymphoma; Stage II Multiple Myeloma

Treatments: Other: internet-based intervention; Procedure: management of therapy complications; Procedure: psychosocial assessment and care; Other: questionnaire administration; Procedure: assessment of therapy complications; Procedure: fatigue assessment and management; Other: counseling intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00799461

NCI-2009-01545 (Registry Identifier)

R01CA112631 (U.S. NIH Grant/Contract)

2258.00

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,337 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

1,337 participants in 3 patient groups

Arm I (full website access w/ PST; first study only)

Experimental group

Description:

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.

Treatment:

Other: counseling intervention

Other: questionnaire administration

Procedure: fatigue assessment and management

Procedure: assessment of therapy complications

Other: internet-based intervention

Procedure: management of therapy complications

Procedure: psychosocial assessment and care

Arm II (full website access without PST)

Experimental group

Description:

Patients receive full access to INSPIRE website for 6 months as in arm I.

Treatment:

Other: questionnaire administration

Procedure: fatigue assessment and management

Procedure: assessment of therapy complications

Other: internet-based intervention

Procedure: management of therapy complications

Procedure: psychosocial assessment and care

Arm III (delayed website access)

Sham Comparator group

Description:

Patients do not have access to INSPIRE website for 6 months. After 6 months, patients receive full access to INSPIRE website for 3 months.

Treatment:

Other: questionnaire administration

Procedure: fatigue assessment and management

Procedure: assessment of therapy complications

Other: internet-based intervention

Procedure: management of therapy complications

Procedure: psychosocial assessment and care