Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment

Condition(s) studied

Investigational drug(s) / intervention(s)

Adapted exercises: Patients will have 3 sessions a week: 1 strengthening session and 2 endurance sessions. For each session, patients will choose the exercises to be performed from the exercise booklet or the videos and records their observations in the patient notebook. Depending on the treatment plan, patients will have alternating supervised (in hospital) and unsupervised (at home) APA sessions, in order to follow the rhythm of their visits to the department. Each session will last 45 minutes with a medium intensity according to the Borg scale.

No intervention: Patients will not be practising adapted exercises as part of the study. They will be treated with chemotherapy according to standard practice.

Quality of Life questionnaire: QoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation

Questionnaire of Fatigue: Questionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation

Physical activity questionnaire: Questionnaire (IPAQ) at baseline and after transplantation

Physical condition: Evaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation

Study summary

Adapted physical activity for patients with haematological malignancies generally has positive effects on quality of life, fatigue and physical condition. However, some studies show little or no effect.

This may be explained by inefficient protocols, but also by low rates of patient acceptability regarding the proposed exercises.

The multiplicity of APA protocols and the fluctuation of their results mean that validity, methodology and effects on patients need to be verified before they can be considered for implementation in healthcare services. A program must prove its feasibility, but patients must also adhere to it.

Acceptability can be measured by adherence, which represents the number of validated sessions in relation to the number of planned sessions, and by attrition, which corresponds to the number of stops or drop-outs for any reason. The various APA programs offered in the context of intensive auto or allograft treatment are limited, notably by adherence, which can fall by as much as 24%, and attrition, which can be as high as 67%. Optimization of the proposed exercises and follow-up methods is therefore necessary in order to propose an APA program that will be feasible, effective and acceptable to a maximum number of patients.

To meet these objectives for patients with multiple myeloma eligible for autologous stem cell transplantation, the protocol for this study took into consideration the various recommendations of previous publications and the guidelines from HAS (French National Authority for Health).

The ultimate goal of this study is to validate, in terms of effectiveness and acceptability, the methodology and in particular the use of new specific tools for optimizing an APA program. It will subsequently be offered to all patients with multiple myeloma eligible for autologous stem cell transplantation, independently of their age or physical condition, while respecting their rhythm and physical condition.

Eligibility

Primary outcome measure(s)

• 1. Evaluate the effect of the APA program on fatigue status. — Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)
  Cancer Related Fatigue : EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).

Trial sites (1)

More Centre Hospitalier Henri Duffaut - Avignon trials in France

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