UPLYFT For Lymphoma Survivors

NCT ID: NCT05080166

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphoma Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Interview with Clinicians

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Field Test of UPLYFT with Lymphoma Survivors

Intervention Type OTHER

6 session of UPLYFT intervention with Lymphoma Survivors for feedback

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.

Group Type EXPERIMENTAL

Pilot of UPLYFT with Lymphoma Survivors

Intervention Type BEHAVIORAL

6 session of UPLYFT intervention with Lymphoma Survivors

Interventions

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Interview with Clinicians

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

Intervention Type OTHER

Field Test of UPLYFT with Lymphoma Survivors

6 session of UPLYFT intervention with Lymphoma Survivors for feedback

Intervention Type OTHER

Pilot of UPLYFT with Lymphoma Survivors

6 session of UPLYFT intervention with Lymphoma Survivors

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Hematology

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Oreofe Odejide, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oreofe O Odejide, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Oreofe O Odejide, MD, MPH

Role: CONTACT

(617) 632-6864

Facility Contacts

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Oreofe O Odejide, MD, MPH

Role: primary

617-632-6864

Other Identifiers

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21-409

Identifier Type: -

Identifier Source: org_study_id

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