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Completed

NCT Number: NCT04052126

An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies

Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects patients' physical capacities and quality of life, already declining with age and comorbidities. It therefore seems essential to develop and evaluate interventions that can prevent physical and psychosocial decline and its consequences in these populations. However, no studies have evaluated a physical activity (PA) program among these populations, although the absence of risk of implementing PA during intense therapeutic procedures has been confirmed.

OCAPI is an interdisciplinary, prospective, interventional, feasibility study. It is intended to include 20 AML and 20 NHL patients 65 years of age or older at the time of initiation of the first chemotherapy line, with an ECOG <3, with no contraindications to PA and no history or coexistence of other primary cancer.

Expected results are to demonstrate that a program offering supervised sessions in a sterile room or at home and remote support can enable patients with AML or NHL to perform their daily PA in autonomy. All these results will generate preliminary data before implementing a larger national study.

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Key information

Conditions

Aged Aged, 80 and Over Behavior Exercise Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 and over,
  • With histologically confirmed non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML),
  • Requiring a first line of chemotherapy treatment or Azacitidine - Vénétoclax combination,
  • Followed-up in one of the investigating centers,
  • Residing in one of the following departments: Ain, Ardèche, Drôme, Isère, Loire, Rhône, Savoie, Haute-Savoie,
  • Having a ECOG < 3,
  • With a life expectancy > 6 months,
  • Whose ability to engage in physical activity has been certified by a medical certificate issued by the investigator physician,
  • Available and willing to participate in the study for the duration of the intervention and follow-up,
  • Able to understand, read and write French,
  • Affiliated with a social security scheme,
  • Having dated and signed an informed consent.

Exclusion criteria

  • Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
  • Treated by immunotherapy alone,
  • Participating in concurrent physical activity studies,
  • Deprived of their liberty by court or administrative decision.

Treatment and study plan

Individualized physical activity program

Other

Participants who agreed to participate in the study will participate in an individualized 6-month physical activity (PA) program, consisting of 3 periods: initiation (1st month), transition (2nd-3rd months) and autonomy (4th-6th months). It is based on 4 PA modalities:

The supervised PA session in a sterile room or at home once a week during the initiation and transition phases (20-45 min, low-to-moderate intensity, walking, muscle strengthening, balance and flexibility exercises).

The unsupervised PA session in a sterile room or at home once a week during the transition phase and twice a week during the autonomy phase (same as supervised session).

Follow-up by telephone once a month during the autonomy phase (30 min, support to PA).

Continuously wearing an activity tracker throughout the entire program (promotion of walking).

Activities are planned over a period of 6 months to achieve an intervention that meets the key principles of progression, specificity and empowerment.

Primary outcomes

  1. Compliance rate of the physical activity sessions

    Time frame: 6 months

    Ratio of the number of supervised and unsupervised sessions performed by patients / number of scheduled sessions

  2. Compliance rate of the phone calls

    Time frame: 6 months

    Ratio of the number of phone calls performed / number of scheduled calls

  3. Compliance rate of the activity tracker

    Time frame: 6 months

    Ratio of the number of days wearing the activity tracker / number of days of the program

Secondary outcomes

  1. Acceptability of the intervention

    Time frame: At inclusion

    Ratio of number of patients included / number of eligible patients

  2. Safety of the intervention

    Time frame: 6 months

    Number, type and timing of program-related adverse events

  3. Adherence of the intervention

    Time frame: 3 months and 6 months

    Ratio of the number of patients still in the program / number of patients included in the study

  4. Impact of the program on autonomy for activities of daily living

    Time frame: At inclusion, 3 months and 6 months

    Activities of Daily Living questionnaire (ADL) - scale from 0 to 6, 0=autonomy; 6 = no autonomy

  5. Impact of the program on autonomy for instrumental activities of daily living

    Time frame: At inclusion, 3 months and 6 months

    Instrumental activities of Daily Living questionnaire (IADL) - scale from 0 to 4, 0=autonomy; 4 = no autonomy

  6. Impact of the program on upper body strength

    Time frame: At inclusion, 3 months and 6 months

    30-s Arm Curl Test

  7. Impact of the program on lower body strength

    Time frame: At inclusion, 3 months and 6 months

    30-s Chair Stand Test

  8. Impact of the program on upper body flexibility

    Time frame: At inclusion, 3 months and 6 months

    Back Scratch Test

  9. Impact of the program on lower body flexibility

    Time frame: At inclusion, 3 months and 6 months

    Chair Sit and Reach Test

  10. Impact of the program on agility

    Time frame: At inclusion, 3 months and 6 months

    Timed Up and Go Test

  11. Impact of the program on walking endurance

    Time frame: At inclusion, 3 months and 6 months

    6-min Walk Test

  12. Impact of the program on walking speed

    Time frame: At inclusion, 3 months and 6 months

    10-m Walk Test

  13. Impact of the program on balance

    Time frame: At inclusion, 3 months and 6 months

    Open-eyes Unipodal Test

  14. Impact of the program on grip strength

    Time frame: At inclusion, 3 months and 6 months

    Hand Grip Dynamometer Test

  15. Impact of the program on anthropometrics

    Time frame: At inclusion, 3 months and 6 months

    BMI (weight and height will be combined to report BMI in kg/m^2)

  16. Impact of the program on nutrition

    Time frame: At inclusion, 3 months and 6 months

    Mini Nutritional Assessment (MNA) - scale from 0 to 30 points; score<17=bad nutritional status ; 17 and 23.5=risk of malnutrition ; >24: adaptednutritional status

  17. Impact of the program on cognition

    Time frame: At inclusion, 3 months and 6 months

    Montreal Cognitive Assessment (MoCA) ; scale from 0 to 30; normal if score >16

  18. Impact of the program on depression

    Time frame: At inclusion, 3 months and 6 months

    Geriatric Depression Scale-15 (GDS-15) ; scale from 0 to 15 ; 0 to 5=normal ; 6 and 9 = high probability of depression ; > 9 = almost systematic depression

  19. Impact of the program on self-efficacy

    Time frame: At inclusion, 3 months and 6 months

    Self-efficacy for exercise scale - This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.

  20. Impact of the program on comorbidities

    Time frame: At inclusion, 3 months and 6 months

    Cumulativ Illness Rating Scale - Geriatric (CIRS-G) ; 14 items ; for each one, score from 0 to 4 : 0=no problem and 4=serious issue

  21. Impact of the program on health-related quality of life

    Time frame: At inclusion, 3 months, 6 months and 1 year

    European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) - scale from 0 to 100

  22. Impact of the program on fatigue

    Time frame: At inclusion, 3 months, 6 months and 1 year

    Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) ; score from 0 to 65 ; the higher the score is, the less the patient has fatigue

  23. Impact of the program on the level of physical activity

    Time frame: At inclusion, 3 months, 6 months and 1 year

    Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ) ; Godin scale score: < 14 units: insufficiently active/sedentary ; 14-23: moderately active ; 24 or more : active

  24. Impact of the program on exercise barriers

    Time frame: At inclusion, 3 months, 6 months and 1 year

    Barriers to Being Active Quiz

  25. Impact of the program on social vulnerability

    Time frame: At inclusion and 1 year

    Évaluation de la précarité et des inégalités de santé pour les CES (EPICES questionnaire) - scale from 0 to 100, 0= no social vulnerability, 100=max vulnerability, threshold=30

  26. Impact of the program on falls

    Time frame: At inclusion and 1 year

    Number of falls

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

An Interventional Prospective Study to Test the Feasibility of an Individualized Physical Activity Program in Patients Over 65 Years of Age With Hematologic Malignancies: the OCAPI Project.

Acronym: OCAPI

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Aug 9, 2019
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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