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Accelerated Phase Chronic Myelogenous LeukemiaPhase 3NCT00799461

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

A Phase 3 study testing internet-based intervention, questionnaire administration and psychosocial assessment and care in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Lymphoblastic Leukemia in Remission, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
internet-based intervention, questionnaire administration and psychosocial assessment and care
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,337 participants
Where
1 siteUnited States
Study dates
Aug 2008to Nov 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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

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

Read the detailed description

OBJECTIVES:

  1. 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.

Being tested
internet-based intervention, questionnaire administration, psychosocial assessment and care, assessment of therapy complications, management of therapy complications
Medical subject headings
Leukemia, Myeloid, Accelerated Phase, Congenital Abnormalities, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Blast Crisis, Pdgfra-Associated Chronic Eosinophilic Leukemia, Leukemia, Myelomonocytic, Chronic, Leukemia, Neutrophilic, Chronic, Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • internet-based interventionOther

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

  • questionnaire administrationOther

    Completion of questions in an online format

  • psychosocial assessment and careProcedure or surgery

    Also called psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment

    Assessment and care of psychosocial aspects

  • assessment of therapy complicationsProcedure or surgery

    Evaluation of complications of treatment

  • management of therapy complicationsProcedure or surgery

    Also called complications of therapy, management of

    Managing therapy complications

  • fatigue assessment and managementProcedure or surgery

    Also called fatigue assessment/management

    Assessing and managing fatigue

  • counseling interventionOther

    Also called counseling and communications studies

    Counseling provided via telephone

Study groups in NCT00799461
Study groupRoleWhat they receive
Arm I (full website access w/ PST; first study only)ExperimentalPatients 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.
Receives: Other: internet-based intervention; Other: questionnaire administration; Procedure: psychosocial assessment and care; Procedure: assessment of therapy complications; Procedure: management of therapy complications; Procedure: fatigue assessment and management; Other: counseling intervention
Arm II (full website access without PST)ExperimentalPatients receive full access to INSPIRE website for 6 months as in arm I.
Receives: Other: internet-based intervention; Other: questionnaire administration; Procedure: psychosocial assessment and care; Procedure: assessment of therapy complications; Procedure: management of therapy complications; Procedure: fatigue assessment and management
Arm III (delayed website access)Sham comparatorPatients do not have access to INSPIRE website for 6 months. After 6 months, patients receive full access to INSPIRE website for 3 months.
Receives: Other: internet-based intervention; Other: questionnaire administration; Procedure: psychosocial assessment and care; Procedure: assessment of therapy complications; Procedure: management of therapy complications; Procedure: fatigue assessment and management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aggregate number of targeted problems

    Measured: At 6 months

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

    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

    Measured: At 6 months

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

    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)

    Measured: At 6 months

  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)

    Measured: 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)

    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

    Measured: At 6 months

Secondary outcomes (5)

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

    Measured: At 6 months

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

    Measured: At 6 months

  3. Total health care utilization behaviors

    Measured: At 6 months

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

    Measured: At 6 months

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

    Measured: At 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Enrolment
1,337 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00799461
Sponsor's protocol ID
2258.00
Other IDs
NCI-2009-01545, R01CA112631
Status last verified
Mar 2012
First submitted
26 Nov 2008
Last updated
7 Mar 2012
Results posted
No
Data monitoring committee
No

Publications

  • Walsh CA, Yi JC, Leisenring WM, Syrjala KL. Social Support, Coping, and Cancer-Related Health Burden in Long-term Survivors Treated with Hematopoietic Stem Cell Transplantation as Adolescents or Young Adults. J Adolesc Young Adult Oncol. 2023 Aug;12(4):496-502. doi: 10.1089/jayao.2022.0105. Epub 2022 Oct 25.

    PubMed 36282798

  • Norskov KH, Yi JC, Crouch ML, Fiscalini AS, Flowers MED, Syrjala KL. Social support as a moderator of healthcare adherence and distress in long-term hematopoietic cell transplantation survivors. J Cancer Surviv. 2021 Dec;15(6):866-875. doi: 10.1007/s11764-020-00979-4. Epub 2021 Jan 9.

    PubMed 33420905

  • Walsh CA, Yi JC, Rosenberg AR, Crouch MV, Leisenring WM, Syrjala KL. Factors associated with social functioning among long-term cancer survivors treated with hematopoietic stem cell transplantation as adolescents or young adults. Psychooncology. 2020 Oct;29(10):1579-1586. doi: 10.1002/pon.5460. Epub 2020 Aug 13.

    PubMed 32628342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing internet-based intervention, questionnaire administration and psychosocial assessment and care in people with Accelerated Phase Chronic Myelogenous Leukemia and Adult Acute Lymphoblastic Leukemia in Remission, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aggregate number of targeted problems (time frame: At 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00799461, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.

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