Clinical trial NCT05080166: UPLYFT For Lymphoma Survivors
Official title: An Intervention for Fear of Cancer Recurrence for Lymphoma Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphoma
Survivorship
Keywords: Lymphoma
Survivorship
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Society of Hematology
First posted: 2021-10-15
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: Enrollment Rate
timeFrame: Up to 6 months
measure: Feasibility: Program Session Completion Rate
timeFrame: Up to 6 months
measure: Feasibility: Data Collection Completion Rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: Acceptability: Satisfaction Rate
timeFrame: Up to 6 months
measure: Acceptability: Disenrollment Rate
timeFrame: Up to 6 months
measure: Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change
timeFrame: Up to 6 months
measure: Preliminary efficacy: Quality of Life Change
timeFrame: Up to 6 months
measure: Preliminary efficacy: Anxiety Change
timeFrame: Up to 6 months
measure: Preliminary efficacy: Depression Change
timeFrame: Up to 6 months
measure: Preliminary efficacy: Psychological inflexibility Change
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Oreofe_Odejide@dfci.harvard.edu
name: Oreofe O Odejide, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: