UPLYFT For Lymphoma Survivors

NCT05080166 | Recruiting

• 1 other identifier: 21-409
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to field test and pilot an intervention called UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) that includes information about lymphoma survivorship and tools to improve quality of life and reduce lymphoma-related worries among lymphoma survivors.

Conditions

Lymphoma; Survivorship

Keywords

Lymphoma; Survivorship

Outcome Measures

Primary Outcomes (3)

• Feasibility: Enrollment Rate

  Proportion of eligible patients approached that enroll in the study.

  Up to 6 months

• Feasibility: Program Session Completion Rate

  Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions.

  Up to 6 months

• Feasibility: Data Collection Completion Rate

  Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.

  Up to 6 months

Secondary Outcomes (7)

• Acceptability: Satisfaction Rate

  Up to 6 months

• Acceptability: Disenrollment Rate

  Up to 6 months

• Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change

  Up to 6 months

• Preliminary efficacy: Quality of Life Change

  Up to 6 months

• Preliminary efficacy: Anxiety Change

  Up to 6 months

Study Arms (3)

Clinicians Interviews

EXPERIMENTAL

Lymphoma and mental health clinicians will participate in 1x in-depth qualitative interview to provide feedback for the development of the UPLYFT program.

Other: Interview with Clinicians

Lymphoma Survivors Field Test

EXPERIMENTAL

A six person group of lymphoma survivors will participate in a six session UPLYFT program field test to provide feedback for the development of the UPLYFT program.

Other: Field Test of UPLYFT with Lymphoma Survivors

UPLYFT Pilot

EXPERIMENTAL

Lymphoma survivors will participate in the phase 1 finalized, six session UPLYFT program. Participants will be randomized 1:1 to either UPLYFT or usual care.

Behavioral: Pilot of UPLYFT with Lymphoma Survivors

Interventions

Interview with Clinicians OTHER

One time, qualitative interview of clinicians for feedback on UPLYFT intervention

Clinicians Interviews

Field Test of UPLYFT with Lymphoma Survivors OTHER

6 session of UPLYFT intervention with Lymphoma Survivors for feedback

Lymphoma Survivors Field Test

Pilot of UPLYFT with Lymphoma Survivors BEHAVIORAL

6 session of UPLYFT intervention with Lymphoma Survivors

UPLYFT Pilot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lymphoma Survivors Phase 1 and 2:
• Diagnosis of lymphoma (indolent non-Hodgkin lymphoma, aggressive non-Hodgkin lymphoma, or classic Hodgkin lymphoma)
• Age ≥ 18 years
• Interval of 3 months to 24 months from completion of first-line treatment
• In complete remission after first line of treatment
• Clinically significant FCR (score of ≥ 16 on the validated FCR Inventory-Severity Subscale \[FCRI-SS).
• Access to computer (for videoconferencing)
• Lymphoma clinicians and mental health clinicians Phase 1:
• Lymphoma clinicians ≥ 1 year from oncology fellowship completion OR mental health clinicians (psychologists, social workers, psychiatrists) ≥ 1 year from completion of clinical training.
• Longitudinal clinical care for patients with lymphoma by oncologists OR provision of care for patients with cancer by mental health clinicians

You may not qualify if:

• Lymphoma Survivors Phase 1:
• Age \< 18 years
• Concurrent other malignancy
• Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorder (as ascertained from medical record screen).
• Lymphoma Survivors Phase 2:
• Age \< 18 years
• Concurrent other malignancy
• Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorders (as ascertained from medical record screen).
• Our study will exclude members of the following special populations:
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• American Society of Hematology: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Oreofe O Odejide, MD, PhD

  Oreofe_Odejide@dfci.harvard.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oreofe O Odejide, MD, MPH

CONTACT

(617) 632-6864; Oreofe_Odejide@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 15, 2021
• Study Start: February 8, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)