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Pedometer Activity Monitoring After ASCT (PAMAL)

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ClinicalTrials.gov Identifier: NCT03238599
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
The trial assess the proportion of patients who resumed their professional activity within 100 days after ASCT (autologous stem cell Transplantation).

Condition or disease Intervention/treatment Phase
Lymphoma Myeloma High-dose Chemotherapy Autologous Stem Cell Transplantation Behavioral: Pedometer-based activity monitoring after ASCT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Non-randomized prospective non-blinded single-arm clinical phase II study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Trial Investigating Pedometer-based Activity Monitoring After Autologous Transplantation in Lymphoma and Myeloma Patients
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Pedometer-based activity monitoring
The physical activity of patients after autologous transplantation for lymphoma and myeloma is measured with the pedometer
Behavioral: Pedometer-based activity monitoring after ASCT
Measurement of physical daily activity using a digital step counter (Pedometer-based activity monitoring) and assessment of patient well-being using a web-based patient reported tool.




Primary Outcome Measures :
  1. Professional Activity [ Time Frame: 100 days ]
    Number of patients who resumed their professional activity within 100 days after ASCT.


Secondary Outcome Measures :
  1. Physical activity [ Time Frame: 100 days ]
    Web-based patient reported physical activity assessed by digital step counting after autologous transplant.

  2. Febrile Episodes [ Time Frame: 100 days ]
    Web-based patient reported febrile episodes after autologous transplant.

  3. Well-being [ Time Frame: 100 days ]
    Web-based patient reported well-being assessed by digital follow-up reporting after autologous transplant.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with plasma cell disorders (myeloma and amyloidosis) or with lymphomas (NHL and Hodgkin) undergoing high-dose chemotherapy with autologous stem cell transplantation.
  • Patients must be aged 18-65 years.
  • Patients must have given voluntary written informed consent.
  • Patients without professional activity (such as due to early retirement, dependency on disability reimbursement, or unemployment) are eligible.

Exclusion Criteria:

  • Patients with other serious medical condition that could potentially interfere with the completion of treatment according to this protocol.
  • Lack of patient cooperation to allow study treatment as outlined in this protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238599


Contacts
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Contact: Thomas Pabst, MD +41 31 632 84 30 thomas.pabst@insel.ch

Locations
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Switzerland
Departement of Medical Oncology, University Hospital Berne Recruiting
Berne, Switzerland, 3010
Contact: Thomas Pabst, MD    +41 31 632 84 30    thomas.pabst@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Study Chair: Thomas Pabst, MD Departement of Medical Oncology, University Hospital Berne
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03238599    
Other Study ID Numbers: PAMAL trial
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases