UPLYFT For Lymphoma Survivors

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Survivorship; Lymphoma

Treatments: Behavioral: Pilot of UPLYFT with Lymphoma Survivors; Other: Field Test of UPLYFT with Lymphoma Survivors; Other: Interview with Clinicians

Study type: Interventional

Funder types: Other

Identifiers

NCT05080166

21-409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 3 patient groups

Clinicians Interviews

Experimental group

Description:

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

Treatment:

Other: Interview with Clinicians

Lymphoma Survivors Field Test

Experimental group

Description:

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.

Treatment:

Other: Field Test of UPLYFT with Lymphoma Survivors

UPLYFT Pilot

Experimental group

Description:

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.

Treatment:

Behavioral: Pilot of UPLYFT with Lymphoma Survivors