Pedometer Activity Monitoring After ASCT

NCT03238599 | Completed Phase 2

• 1 other identifier: PAMAL trial
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoma; Myeloma; High-dose Chemotherapy; Autologous Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Professional Activity

  Number of patients who resumed their professional activity within 100 days after ASCT.

  100 days

Secondary Outcomes (3)

• Physical activity

  100 days

• Febrile Episodes

  100 days

• Well-being

  100 days

Study Arms (1)

Pedometer-based activity monitoring

EXPERIMENTAL

The physical activity of patients after autologous transplantation for lymphoma and myeloma is measured with the pedometer

Behavioral: Pedometer-based activity monitoring after ASCT

Interventions

Pedometer-based activity monitoring after ASCT BEHAVIORAL

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.

Pedometer-based activity monitoring

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Departement of Medical Oncology, University Hospital Berne

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Lymphoma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Thomas Pabst, MD

  Departement of Medical Oncology, University Hospital Berne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized prospective non-blinded single-arm clinical phase II study

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 3, 2017
• Study Start: November 2, 2017
• Primary Completion: February 15, 2022
• Study Completion: March 1, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)