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NCT Number: NCT05080166

UPLYFT 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Oreofe O Odejide, MD, MPH

CONTACT

[email protected]

617-632-6864

Oreofe O Odejide, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interview with Clinicians

Other

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

Field Test of UPLYFT with Lymphoma Survivors

Other

6 session of UPLYFT intervention with Lymphoma Survivors for feedback

Pilot of UPLYFT with Lymphoma Survivors

Behavioral

6 session of UPLYFT intervention with Lymphoma Survivors

Primary outcomes

  1. Feasibility: Enrollment Rate

    Time frame: Up to 6 months

    Proportion of eligible patients approached that enroll in the study.

  2. Feasibility: Program Session Completion Rate

    Time frame: Up to 6 months

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

  3. Feasibility: Data Collection Completion Rate

    Time frame: Up to 6 months

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

Secondary outcomes

  1. Acceptability: Satisfaction Rate

    Time frame: 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.

  2. Acceptability: Disenrollment Rate

    Time frame: 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.

  3. Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change

    Time frame: 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.

  4. Preliminary efficacy: Quality of Life Change

    Time frame: 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)

  5. Preliminary efficacy: Anxiety Change

    Time frame: Up to 6 months

    Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale)

  6. Preliminary efficacy: Depression Change

    Time frame: Up to 6 months

    Pre-intervention to post-intervention changes in depression as measured by the Hospital Anxiety and Depression Scale (Depression subscale)

  7. Preliminary efficacy: Psychological inflexibility Change

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Oreofe O Odejide, MD, MPH

CONTACT

[email protected]

(617) 632-6864

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • American Society of Hematology

Registry information

Official study title

An Intervention for Fear of Cancer Recurrence for Lymphoma Survivors

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2021
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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