UPLYFT For Lymphoma Survivors

An Intervention for Fear of Cancer Recurrence for Lymphoma Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma; Survivorship
• Intervention / Treatment: Other: Interview with Clinicians; Other: Field Test of UPLYFT with Lymphoma Survivors; Behavioral: Pilot of UPLYFT with Lymphoma Survivors

Detailed Description

This is a two phase pilot study to develop and pilot the UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) program intervention that includes lymphoma survivorship information and acceptance and commitment therapy strategies to alleviate fear of cancer recurrence, reduce distress, and improve quality of life among lymphoma survivors.

Phase 1 will be a two-part development process of the UPLYFT program based on interview feedback from lymphoma and mental health clinicians and then feedback from a six-person group of lymphoma survivors after participation in an UPLYFT program field test. Phase 2 is a randomized pilot study using the UPLFYT program finalized in Phase 1.

Research procedures include:

• In depth interview (lymphoma and mental health clinicians)
• Screening for eligibility
• 6 weekly intervention sessions (lymphoma survivors)

• Baseline Assessments and Questionnaires (lymphoma survivors)

  74 people are expected to participate in this study with 14 in Phase 1 and 60 in Phase 2.

The American Society of Hematology is providing funding for the trial.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oreofe O Odejide, MD, MPH; Phone Number: (617) 632-6864; Email: Oreofe_Odejide@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Oreofe O Odejide, MD, MPH; Phone Number: 617-632-6864; Email: Oreofe_Odejide@dfci.harvard.edu
      • Principal Investigator: Oreofe O Odejide, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinicians Interviews; 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; One time, qualitative interview of clinicians for feedback on UPLYFT intervention
Experimental: Lymphoma Survivors Field Test; 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; 6 session of UPLYFT intervention with Lymphoma Survivors for feedback
Experimental: UPLYFT Pilot; 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; 6 session of UPLYFT intervention with Lymphoma Survivors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preliminary efficacy: Quality of Life Change	Pre-intervention to post-intervention changes in quality of life measured with the Quality of Life- Cancer Survivor instrument (a 41-item questionnaire)	Up to 6 months
Preliminary efficacy: Anxiety Change	Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale)	Up to 6 months
Preliminary efficacy: Depression Change	Pre-intervention to post-intervention changes in depression as measured by the Hospital Anxiety and Depression Scale (Depression subscale)	Up to 6 months
Preliminary efficacy: Psychological inflexibility Change	Pre-intervention to post-intervention changes in psychological inflexibility as measured by the Acceptance and Action Questionnaire-II (a 7-item scale)	Up to 6 months
Acceptability: Satisfaction Rate	Satisfaction rate is defined as the proportion of study participants randomized to the intervention arm who are satisfied with the UPLYFT program and proportion who are likely to recommend the program.	Up to 6 months
Acceptability: Disenrollment Rate	Disenrollment rate is defined as the proportion of eligible patients who enroll in the study who then choose to disenroll from the study.	Up to 6 months
Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change	Pre-intervention to post-intervention changes in Fear of Cancer Recurrence (FCR) measured with the Fear of Cancer Recurrence Inventory (FCRI, 42-item questionnaire), with a focus on the FCRI severity subscale.	Up to 6 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: American Society of Hematology
• Investigators: Principal Investigator: Oreofe O Odejide, MD, PhD, Oreofe_Odejide@dfci.harvard.edu

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Lymphoma; Survivorship
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemic and Lymphatic Diseases; Lymphoma; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic
• Other Study ID Numbers: 21-409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No