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

NCT04914338 | Active Not Recruiting DMC

• 3 other identifiers: 21026NCI-2021-03939P30CA033572
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

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

  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.

  Up to 1 year

Secondary Outcomes (4)

• Dose intensity of resiliency bolstering

  Up to 1 year

• Rate of hematopoietic cell transplantation (HCT) utilization

  Up to 1 year

• Library of MDT-facilitated intervention

  Up to 1 year

• Functional independent survival (FIS)

  Days 30, 60, 100

Study Arms (1)

Supportive care (MDT-intervention)

EXPERIMENTAL

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.

Other: Health Promotion; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Health Promotion OTHER

Participate in MDT-intervention

Also known as: Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, Salutogenesis

Supportive care (MDT-intervention)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Supportive care (MDT-intervention)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (MDT-intervention)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Nedical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andrew S Artz

  City of Hope Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 4, 2021
• Study Start: June 3, 2021
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (1)