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

Official title

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

Overview

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.

Interventions

• Other 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 i
• Other No intervention
  Patients will not be practising adapted exercises as part of the study. They will be treated with chemotherapy according to standard practice.
• Behavioral Quality of Life questionnaire
  QoL questionnaire (EORTC QLQ-C30) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation
• Behavioral Questionnaire of Fatigue
  Questionnaire (EORTC QLQ-FA12) at baseline, mid-term (after 2 cycles of chemotherapy), before transplantation, and after transplantation
• Behavioral Physical activity questionnaire
  Questionnaire (IPAQ) at baseline and after transplantation
• Behavioral Physical condition
  Evaluation of physical condition at baseline, mid term (after 2 cycles of chemotherapy), before transplantation and after transplantation

Primary outcome measures

• 1. Evaluate the effect of the APA program on fatigue status. [Time frame: 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)]

Secondary outcome measures (12)

• Evaluate the effect of the APA program on quality of life. [Time frame: 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)]
• Fitness assessment. [Time frame: 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)]
• Fitness assessment. [Time frame: 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)]
• Fitness assessment. [Time frame: 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)]
• Nutritional status. [Time frame: 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)]
• Grade III-IV adverse events rate. [Time frame: From inclusion to assessment after transplant (on average about 30 weeks after inclusion)]
• Comparison of hospitalization length. [Time frame: Assessment after transplant (on average about 30 weeks after inclusion)]
• 15. Attraction to sport assessment. [Time frame: Assessment after transplant (on average about 30 weeks after inclusion)]
• Adherence rate. [Time frame: Assessment after transplant (on average about 30 weeks after inclusion)]
• Attrition rate. [Time frame: Assessment after transplant (on average about 30 weeks after inclusion)]
• Rate of effective APA sessions. [Time frame: Assessment after transplant (on average about 30 weeks after inclusion)]
• Reasons for discontinuing the APA program. [Time frame: Assessment after transplant (on average about 30 weeks after inclusion)]

Eligibility criteria

Inclusion criteria

• Age ≥ 18 years old.
• CML patient in chronic phase, eligible for oral therapy.
• Diagnosis of multiple myeloma.
• Patient eligible for autologous stem cell transplantation.
• Patient capable to read, understand and complete a questionnaire in french.
• WHO less than or equal to 2.
• Patient affiliated with french social security.
• Patient with a medical prescription for APA.

Exclusion criteria

• Patient with previous cancer within the previous 3 years (except basal cell and squamous cell skin cancers, carcinomas in situ of any type that have been previously resected, and stable prostate or breast cancers more than 3 years old and undergoing adjuvant hormone therapy).
• Medical contraindications to APA (heart failure, angina, unbalanced hypertension, bone metastases, severe osteoporosis, etc.)
• Sensory or motor neuropathy.
• Patient deprived of liberty, under guardianship or curatorship.
• Patient considered socially or psychologically unfit to be enrolled in a study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

• Centre Hospitalier d'Avignon, Hôpital Henri Duffaut — Avignon

Identifiers

NCT: NCT06789003 · PREHAB-APA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗