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

NCT ID: NCT06789003

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2028-02-28

Brief 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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

APA group

Group Type: EXPERIMENTAL

Adapted exercises

Intervention Type: OTHER

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.

Quality of Life questionnaire

Intervention Type: BEHAVIORAL

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

Questionnaire of Fatigue

Intervention Type: BEHAVIORAL

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

Physical activity questionnaire

Intervention Type: BEHAVIORAL

Questionnaire (IPAQ) at baseline and after transplantation

Physical condition

Intervention Type: BEHAVIORAL

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

Control group

Group Type: ACTIVE_COMPARATOR

No intervention

Intervention Type: OTHER

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

Intervention Type: BEHAVIORAL

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

Questionnaire of Fatigue

Intervention Type: BEHAVIORAL

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

Physical activity questionnaire

Intervention Type: BEHAVIORAL

Questionnaire (IPAQ) at baseline and after transplantation

Physical condition

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Quality of Life questionnaire

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

Intervention Type: BEHAVIORAL

Questionnaire of Fatigue

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

Intervention Type: BEHAVIORAL

Physical activity questionnaire

Questionnaire (IPAQ) at baseline and after transplantation

Intervention Type: BEHAVIORAL

Physical condition

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

Intervention Type: BEHAVIORAL

Other Intervention Names

30s chair-stand test; Handgrip strength test; 6 minutes walk test

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Henri Duffaut - Avignon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier d'Avignon, Hôpital Henri Duffaut

Avignon, , France

Countries

France

Central Contacts

Marilyne Grinand, PhD

Role: CONTACT

grinand.marilyne@ch-avignon.fr

(+33)432759392

Emmanuelle Guilie, APA

Role: CONTACT

guilie.emmanuelle@ch-avignon.fr

(+33)432759300

Facility Contacts

Marilyne Grinand, PhD

Role: primary

grinand.marilyne@ch-avignon.fr

(+33)0432759392

Emmanuelle Guilie, APA

Role: backup

Safia Chebrek, MD

Role: backup

Other Identifiers

PREHAB-APA

Identifier Type: -

Identifier Source: org_study_id