Clinical trial · Interventional
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
INSPIRE: An Internet-based RCT for Long-term Survivors of Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (92)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Accelerated Phase Chronic Myelogenous Leukemia | Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Adult Acute Lymphoblastic Leukemia in Remission | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia in Remission | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| counseling intervention | Other | — | UNRESOLVED |
| fatigue assessment and management | Procedure | — | UNRESOLVED |
| internet-based intervention | Other | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (full website access w/ PST; first study only)
- 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.
- interventionNames
- 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
- type
- EXPERIMENTAL
- label
- Arm II (full website access without PST)
- description
- Patients receive full access to INSPIRE website for 6 months as in arm I.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDWalsh 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. PMID 36282798
- DERIVEDNorskov 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. PMID 33420905
- DERIVEDWalsh 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. PMID 32628342