UPLYFT For Lymphoma Survivors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 will then conduct a full scale pilot study using the UPLFYT program finalized in Phase 1.
Research procedures include:
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In depth interview (lymphoma and mental health clinicians)
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Screening for eligibility
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6 weekly intervention sessions (lymphoma survivors)
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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.
American Society of Hematology is providing funding for the trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: Interview with Clinicians
One time, qualitative interview of clinicians for feedback on UPLYFT intervention
|
| Experimental: 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. |
Other: Field Test of UPLYFT with Lymphoma Survivors
6 session of UPLYFT intervention with Lymphoma Survivors for feedback
|
| Experimental: UPLYFT Pilot Lymphoma survivors will participate in the phase 1 finalized, six session UPLYFT program. |
Behavioral: Pilot of UPLYFT with Lymphoma Survivors
6 session of UPLYFT intervention with Lymphoma Survivors
|
Outcome Measures
Primary Outcome Measures
- Feasibility: Enrollment Rate [Up to 6 months]
Feasibility of the Fear of Cancer Recurrence (FCR) intervention (UPLYFT) defined as ≥50% enrollment of eligible patients approached
- Feasibility: Program Session Completion Rate [Up to 6 months]
Feasibility of the FCR intervention (UPLYFT) defined as ≥ 70% completion of intervention sessions,
- Feasibility: Data Collection Completion Rate [Up to 6 months]
Feasibility of the FCR intervention (UPLYFT) defined as ≥70% completion of patient-reported data collection.
Secondary Outcome Measures
- Acceptability: Satisfaction Rate [Up to 6 months]
Acceptability of the FCR intervention (UPLYFT) defined as ≥ 90% satisfaction rate
- Acceptability: Disenrollment Rate [Up to 6 months]
Acceptability of the FCR intervention (UPLYFT) defined ≤ 10% disenrollment rate
- 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 (42-item questionnaire)
- 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: 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: 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: 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
Lymphoma Survivors Phase 1 and 2:
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Diagnosis of lymphoma (indolent non-Hodgkin lymphoma, aggressive non-Hodgkin lymphoma, or classic Hodgkin lymphoma)
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Age ≥ 18 years
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Interval of 3 months to 24 months from completion of first-line treatment
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In complete remission after first line of treatment
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Clinically significant FCR (score of ≥ 16 on the validated FCR Inventory-Severity Subscale [FCRI-SS).
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Access to computer (for videoconferencing)
Lymphoma clinicians and mental health clinicians Phase 1:
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Lymphoma clinicians ≥ 1 year from oncology fellowship completion OR mental health clinicians (psychologists, social workers, psychiatrists) ≥ 1 year from completion of clinical training.
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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:
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Age < 18 years
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Concurrent other malignancy
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Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorder (as ascertained from medical record screen).
Lymphoma Survivors Phase 2:
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Age < 18 years
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Concurrent other malignancy
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Patients with uncontrolled/untreated psychotic disorders or untreated bipolar and borderline personality disorders (as ascertained from medical record screen).
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Our study will exclude members of the following special populations:
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Adults unable to consent
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Individuals who are not yet adults (infants, children, teenagers)
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Pregnant women
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Prisoners
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- American Society of Hematology
Investigators
- Principal Investigator: Oreofe O Odejide, MD, PhD, Oreofe_Odejide@dfci.harvard.edu
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-409