Pedometer Activity Monitoring After ASCT
Condition: Lymphoma; Myeloma; High-dose Chemotherapy; Autologous Stem Cell Transplantation
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

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

Detailed description: 
      Patient-reported outcome measures (PROMs) Cancer patients experience significant physical and
      psychosocial consequences of cancer and treatment which affect quality of life (QoL). These
      consequences may be under-recognized and under-treated in oncology practice, resulting in
      greater morbidity that is costly to patients and the health system. Patient-reported outcome
      measures (PROMs) are advocated for use in routine cancer clinical practice for early
      detection of distress and as a performance metric for evaluating the quality of care on
      health outcomes.

      A PROM is defined as 'any report coming directly from the patient about a health condition
      and its treatment using a self-reported measure. PROMs focus on physical symptoms, treatment
      toxicities, psychosocial problems or global health-related quality of life (HRQoL) impacts of
      a health condition. PROMs that capture the whole-person impact of cancer and treatments on
      health outcomes are increasingly recommended by patients, clinicians, and decision makers.

      A number of implementation issues related to the use of PROMs data need to be considered: (i)
      limiting data collection so as to minimize patient burden and completion time, (ii)
      collecting PROM data at baseline and selected follow-up times while minimizing the number of
      assessments, (iii) considering whether measurement equivalence has been established when
      using different modes of patient-reported data collection (e.g. web, telephone, tablet, or
      paper), (iv) collecting data via electronic technologies whenever possible, and (v) employing
      methods to minimize missing data including educating site personnel, patients and clinicians,
      and real-time monitoring of adherence.

      Step counting devices to monitor physical activity The intensive medical treatment of
      patients with hematologic malignancies is associated with numerous long-term adverse effects,
      including anemia, fatigue, and reduced physical exercise capacity. Patients with hematologic
      malignancies may benefit from physical exercise programs in terms of maintenance or even
      improvement in fatigue, physical activity, and fitness levels. Since many patients with
      hematologic malignancies are young and professionally active, regaining physical activity is
      a prerequisite for timely resuming professional activities, and, thus, of immediate
      socio-economic relevance. A major component of daily physical activity and the most common
      form of exercise is walking. Walking is self-regulated in intensity, duration, and frequency,
      and it can be an important indicator of a person's health and fitness status. The improvement
      of functional status is a primary goal in the rehabilitation of cancer patients. It is thus
      crucial to be able to document quantitatively the walking activity of patients who are
      recovering from intensive medical treatment. An understanding of the quantity (or lack) of
      walking activity seems particularly important in addressing the needs of cancer patients who
      are recovering from intensive medical treatment

      Patients with hematologic malignancies recovering from intensive medical treatment such as
      after high-dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT) can
      benefit from gradually regaining a more physically active lifestyle, typically by increasing
      ambulatory activity. Step counting devices (accelerometers and pedometers) offer an
      opportunity to monitor daily ambulatory activity. Tudor-Locke and Bassett originally proposed
      a graduated step index to describe pedometer-determined habitual physical activity in adults:

        1. < 5,000 steps/day (sedentary);

        2. 5,000-7,499 steps/day (low active);

        3. 7,500-9,999 steps/day (somewhat active);

        4. ≥ 10,000-12,499 steps/day (active); and

        5. ≥12,500 steps/day (highly active).

      Recognizing a considerable floor effect (i.e., insensitivity to the range of activity levels
      below the lowest threshold) when applied to low active populations, Tudor-Locke et al
      suggested that the original sedentary level is further divided into two additional
      incremental levels:

      < 2,500 steps/day (basal activity) and 2,500- 4,999 steps/day (limited activity).

      Prospective use of PROMs and step counting devices after ASCT The investigators here propose
      a non-randomized prospective non-blinded non-interventional observational clinical phase II
      study, assessing physical activity in myeloma and lymphoma patients following high-dose
      chemotherapy (HDCT) with autologous stem cell transplantation (ASCT). The primary objective
      is to determine whether regaining a daily activity of at least 5'000 steps (thus, regaining
      the "low active" level) 30 days after HDCT with ASCT is associated with a higher probability
      to resume professional activity.

      The hypothesis will be that 50% or more of those patients who achieve >5'000 steps during one
      day at least once between 10 and 30 days after ASCT will have resumed their professional
      activities at the day 100 assessment, whereas only 30% of those patients, who have not
      achieved the 5'000 steps threshold until day 30, will have restarted their professional life
      at the day 100 assessment. Physical activity will be assessed by a web-based pedometer
      device, and patient-reported outcome measures (PROMs) will be collected using a web-based
      tool.

      The MIDATA.coop platform The trial will use the MIDATA.coop platform based on the principle
      of citizen-controlled data storage and sharing. MIDATA.coop embodies an IT platform managing
      personal data and the governance needed to operate it. As a not-for-profit citizen-owned
      cooperative, its vision is to allow citizens to collect, store, visualize, and share specific
      sets of their personal data with friends and health professionals, and to make anonymized
      versions of part of these data accessible to research projects in fields that appeal to them.
      The value generated by this secondary use of personal data is managed collectively to operate
      and extend the platform and support further research projects.
    

Intervention name(s): Pedometer-based activity monitoring after ASCT
Intervention type(s): Behavioral
Intervention description(s): 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.
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