UPLYFT For Lymphoma Survivors

Not Applicable

Recruiting

• Conditions: Lymphoma; Survivorship
• Interventions: Other: Interview with Clinicians; Behavioral: Pilot of UPLYFT with Lymphoma Survivors; Other: Field Test of UPLYFT with Lymphoma Survivors

• Registration Number: NCT05080166
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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 Timeline

• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-15
• Study Start: 2022-02-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinicians Interviews	Interview with Clinicians	Lymphoma and mental health clinicians will participate in 1x in-depth qualitative interview to provide feedback for the development of the UPLYFT program.
UPLYFT Pilot	Pilot of UPLYFT with Lymphoma Survivors	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.
Lymphoma Survivors Field Test	Field Test of UPLYFT with Lymphoma Survivors	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.

Primary Outcome Measures

Name	Time	Method
Feasibility: Enrollment Rate	Up to 6 months	Proportion of eligible patients approached that enroll in the study.
Feasibility: Program Session Completion Rate	Up to 6 months	Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions.
Feasibility: Data Collection Completion Rate	Up to 6 months	Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.

Secondary Outcome Measures

Name	Time	Method
Acceptability: Disenrollment Rate	Up to 6 months	Disenrollment rate is defined as the proportion of eligible patients who enroll in the study who then choose to disenroll from the study.
Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change	Up to 6 months	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.
Acceptability: Satisfaction Rate	Up to 6 months	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.
Preliminary efficacy: Quality of Life Change	Up to 6 months	Pre-intervention to post-intervention changes in quality of life measured with the Quality of Life- Cancer Survivor instrument (a 41-item questionnaire)
Preliminary efficacy: Depression Change	Up to 6 months	Pre-intervention to post-intervention changes in depression as measured by the Hospital Anxiety and Depression Scale (Depression subscale)
Preliminary efficacy: Anxiety Change	Up to 6 months	Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale)
Preliminary efficacy: Psychological inflexibility Change	Up to 6 months	Pre-intervention to post-intervention changes in psychological inflexibility as measured by the Acceptance and Action Questionnaire-II (a 7-item scale)

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States