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NCT Number: NCT04914338

A Multidisciplinary Approach to Improve the Health of Older Adults With Blood Cancers After Stem Cell Transplantation

This clinical trial studies the usefulness and process of a multidisciplinary intervention, where patients see multiple healthcare professionals, aimed at improving fitness and the ability to bounce back after transplant for older adults with blood cancers planned for stem cell transplantation. Using a multidisciplinary team approach may increase patients' ability to withstand the transplant by optimizing health to better prepare patients for the expected complications after stem cell transplantation.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Nedical Center

Duarte, California, 91010, United States

About this study

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of delivering a geriatric assessment guided by a multi-disciplinary team (MDT) intervention before allogeneic hematopoietic cell transplantation (HCT) in older patients.

SECONDARY OBJECTIVES:

I. Establish successful dose intensity of resiliency bolstering. II. Describe HCT utilization among enrolled patients. III. Create a standardized and exportable library of MDT-facilitated interventions.

IV. Estimate the benefit derived from the MDT approach compared to historic controls for day +100 outcomes of falls, delirium and functional decline.

V. Quantify early functionally independent survival (FIS) to estimate HCT-associated health span decline.

EXPLORATORY OBJECTIVES:

I. Characterize reasons patients do not undergo HCT after MDT intervention. II. Associate early FIS with 1-year non-relapse mortality (NRM) and overall survival (OS).

III. Integrate virtual assessment and interventions. IV. Correlate image defined sarcopenia with objective function. V. Biobank blood and stool for future studies of accelerated aging.

OUTLINE:

Patients participate in the MDT-intervention including access to a HCT physician, a geriatrician, physical or occupational therapist, dietician, and a social worker for three months before HCT and up to 100 days after HCT.

After completion of study, patients are followed up for up to 1 year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Documented informed consent of the participant
  • >= 65 years at time of planned HCT infusion
  • Anticipated to be candidate for allogeneic transplant per treating physician at the time of enrollment
  • Ability to read English, Spanish or Mandarin. Other languages will be acceptable with principal investigator (PI) agreement if surveys are available and language does not preclude completing study procedures
  • Any conditioning regimen and allogeneic donor permitted
  • Hematologic malignancy or disease as indication for HCT
  • Willing and able to complete study requirements

Exclusion criteria

  • Prior allogeneic stem cell transplant
  • Syngeneic donors for HCT
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Treatment and study plan

Health Promotion

Other

Participate in MDT-intervention

Other names: Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, Salutogenesis

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility of multidisciplinary team (MDT) (met 90 percent threshould, yes / no)

    Time frame: Up to 1 year

    Patients are expected to see 6 providers. Success is defined as enrolled patients seen at least 4 out of six providers. The study will meet feasibility endpoint if 90 percent or more of the enrolled patients are flagged as successful. Each patient will be measured as success or failure according to these rules.

Secondary outcomes

  1. Dose intensity of resiliency bolstering

    Time frame: Up to 1 year

    Adequate dose intensity arbitrarily will be defined as completion of at least 11 of 16 process metrics (i.e, approximately 70 percent of more of process measures).

  2. Rate of hematopoietic cell transplantation (HCT) utilization

    Time frame: Up to 1 year

    Measured by summarizing proportion of patients proceeding to allogeneic HCT.

  3. Library of MDT-facilitated intervention

    Time frame: Up to 1 year

    Will provide a standardized library of evaluation and interventions from the MDT approach. A manual of procedures will be created and a database to capture metrics. Will be categorized by the MDT in a Likert scale to the following question: "Is the library of MDT-facilitated interventions ready to be exposure for a randomized controlled trial".

  4. Functional independent survival (FIS)

    Time frame: Days 30, 60, 100

    FIS will be calculated as with first observed failure events of intensive care unit admissions, delirium, falls, or frail 4 meter walk at day 30 or day 100. Functional impairment will use the milestones of day 30, day 60 day 100.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Feasibility of a Multidisciplinary Approach to Circumvent Healthspan Decline After Allogeneic Hematopoietic Cell Transplantation in Older Patients

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 4, 2021
Registry last updated
Mar 5, 2026

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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