LymphomaNCT05080166
UPLYFT For Lymphoma Survivors
A study testing Interview with Clinicians, Field Test of UPLYFT with Lymphoma Survivors and Pilot of UPLYFT with Lymphoma Survivors in people with Lymphoma and Survivorship, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Survivorship
- What is being tested?
- Interview with Clinicians, Field Test of UPLYFT with Lymphoma Survivors and Pilot of UPLYFT with Lymphoma Survivors
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 17 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: An Intervention for Fear of Cancer Recurrence 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.
Read the 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.
- Conditions
- Lymphoma, Survivorship
- Being tested
- Interview with Clinicians, Field Test of UPLYFT with Lymphoma Survivors, Pilot of UPLYFT with Lymphoma Survivors
- Keywords
- Lymphoma, Survivorship
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview with CliniciansOther
One time, qualitative interview of clinicians for feedback on UPLYFT intervention
Field Test of UPLYFT with Lymphoma SurvivorsOther
6 session of UPLYFT intervention with Lymphoma Survivors for feedback
Pilot of UPLYFT with Lymphoma SurvivorsBehavioural
6 session of UPLYFT intervention with Lymphoma Survivors
| Study group | Role | What they receive |
|---|---|---|
| Clinicians Interviews | Experimental | Lymphoma and mental health clinicians will participate in 1x in-depth qualitative interview to provide feedback for the development of the UPLYFT program. Receives: Other: Interview with Clinicians |
| Lymphoma Survivors Field Test | Experimental | 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. Receives: Other: Field Test of UPLYFT with Lymphoma Survivors |
| UPLYFT Pilot | Experimental | 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. Receives: Behavioral: Pilot of UPLYFT with Lymphoma Survivors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Enrollment Rate
Proportion of eligible patients approached that enroll in the study.
Measured: Up to 6 months
Feasibility: Program Session Completion Rate
Proportion of study participants randomized to the intervention arm (UPLYFT) who complete all intervention sessions.
Measured: Up to 6 months
Feasibility: Data Collection Completion Rate
Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.
Measured: Up to 6 months
Secondary outcomes (7)
Acceptability: Satisfaction Rate
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.
Measured: Up to 6 months
Acceptability: Disenrollment Rate
Disenrollment rate is defined as the proportion of eligible patients who enroll in the study who then choose to disenroll from the study.
Measured: Up to 6 months
Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change
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.
Measured: Up to 6 months
Preliminary efficacy: Quality of Life Change
Pre-intervention to post-intervention changes in quality of life measured with the Quality of Life- Cancer Survivor instrument (a 41-item questionnaire)
Measured: Up to 6 months
Preliminary efficacy: Anxiety Change
Pre-intervention to post-intervention changes in anxiety as measured by the Hospital and Anxiety Scale (Anxiety subscale)
Measured: Up to 6 months
Preliminary efficacy: Depression Change
Pre-intervention to post-intervention changes in depression as measured by the Hospital Anxiety and Depression Scale (Depression subscale)
Measured: Up to 6 months
Preliminary efficacy: Psychological inflexibility Change
Pre-intervention to post-intervention changes in psychological inflexibility as measured by the Acceptance and Action Questionnaire-II (a 7-item scale)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start8 Feb 2022
- Primary completion17 Jul 2026
- Study completion17 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Hematology
- Responsible party
- Principal investigator, Oreofe Odejide, MD, Dana-Farber Cancer Institute
- Investigators
- Oreofe O Odejide, MD, PhD, Principal investigator, Oreofe_Odejide@dfci.harvard.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080166
- Sponsor's protocol ID
- 21-409
- Status last verified
- Aug 2026
- First submitted
- 5 Oct 2021
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention for Fear of Cancer Recurrence for Lymphoma Survivors
- ClinicalTrials.gov ID
- NCT05080166
- Acronym / sponsor ID
- 21-409
- Conditions
- Lymphoma, Survivorship
- Keywords
- Lymphoma, Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- American Society of Hematology
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinicians Interviews | Experimental | Other: Interview with CliniciansLymphoma and mental health clinicians will participate in 1x in-depth qualitative interview to provide feedback for the development of the UPLYFT program. |
| Lymphoma Survivors Field Test | Experimental | Other: Field Test of UPLYFT with Lymphoma SurvivorsA 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. |
| UPLYFT Pilot | Experimental | Behavioral: Pilot of UPLYFT with Lymphoma SurvivorsLymphoma survivors will participate in the phase 1 finalized, six session UPLYFT program. Participants will be randomized 1:1 to either UPLYFT or usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (13 listed)
- 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).
- Age < 18 years
- Concurrent other malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview with CliniciansOne time, qualitative interview of clinicians for feedback on UPLYFT intervention | Other | Clinicians Interviews |
| Field Test of UPLYFT with Lymphoma Survivors6 session of UPLYFT intervention with Lymphoma Survivors for feedback | Other | Lymphoma Survivors Field Test |
| Pilot of UPLYFT with Lymphoma Survivors6 session of UPLYFT intervention with Lymphoma Survivors | Behavioural | UPLYFT Pilot |
Primary outcome
Feasibility: Enrollment Rate
Time frame: Up to 6 months
Proportion of eligible patients approached that enroll in the study.
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.
Feasibility: Data Collection Completion Rate
Time frame: Up to 6 months
Proportion of enrolled participants who complete assigned patient-reported questionnaires during the study.
7 secondary outcomes
Acceptability: Satisfaction Rate
Time frame: Up to 6 months
Acceptability: Disenrollment Rate
Time frame: Up to 6 months
Preliminary efficacy: Fear of Cancer Recurrence (FCR) Change
Time frame: Up to 6 months
Preliminary efficacy: Quality of Life Change
Time frame: Up to 6 months
Preliminary efficacy: Anxiety Change
Time frame: Up to 6 months
Preliminary efficacy: Depression Change
Time frame: Up to 6 months
Preliminary efficacy: Psychological inflexibility Change
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oreofe O Odejide, MD, PhD principal investigator
Oreofe_Odejide@dfci.harvard.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview with Clinicians, Field Test of UPLYFT with Lymphoma Survivors and Pilot of UPLYFT with Lymphoma Survivors in people with Lymphoma and Survivorship, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Enrollment Rate (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.