UPLYFT for Lymphoma

Overseen By Oreofe O Odejide, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Other malignancy, Psychotic disorders, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called UPLYFT, designed to help lymphoma survivors by providing information and tools to enhance their quality of life and reduce concerns about cancer recurrence. Participants will include lymphoma survivors and clinicians who provide feedback on the program. Suitable candidates are lymphoma survivors who have completed their first round of treatment and are currently in remission. Survivors must have computer access for online sessions. As an unphased trial, this study offers a unique opportunity to contribute to developing supportive resources for lymphoma survivors.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the UPLYFT intervention is safe for lymphoma survivors?

Research has shown that the UPLYFT program aims to help lymphoma survivors by reducing their worries and improving their quality of life. UPLYFT emphasizes mental health support over medication or physical treatments, making it generally low-risk with no known physical side effects. The program includes sessions to address fears of cancer recurrence, a common concern among cancer survivors. Studies on this type of therapy indicate it is well-received, as it provides information and emotional support. No reports of negative effects have emerged from participating in such programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the UPLYFT program for lymphoma survivors because it focuses on a comprehensive approach to recovery that includes mental health support, which is often overlooked in standard treatments like chemotherapy, radiation, and targeted therapies. Unlike traditional treatments that primarily target the disease itself, UPLYFT integrates mental health and psychosocial support, aiming to improve overall quality of life for survivors. This holistic approach could lead to better long-term outcomes by addressing the emotional and psychological challenges faced by lymphoma survivors, offering a more rounded recovery process.

What evidence suggests that UPLYFT is effective for improving quality of life and reducing worries among lymphoma survivors?

Research has shown that many lymphoma survivors worry about cancer recurrence, affecting their quality of life. More than half of these survivors experience high levels of fear, particularly if they already feel anxious or have a lower quality of life. This fear can lead to emotional stress and complicate social interactions. In this trial, researchers are testing the UPLYFT program, which offers tools and support to manage these worries and enhance well-being. Early evidence suggests that programs like UPLYFT can successfully reduce fear and improve life quality for cancer survivors. ^{1 3 4 6 7}

Who Is on the Research Team?

Oreofe O Odejide, MD, PhD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been treated for lymphoma and are in remission but still experience significant fear of cancer recurrence. They must be within 3 to 24 months post-treatment, have access to a computer, and not have other untreated major psychiatric disorders or concurrent malignancies.

Inclusion Criteria

I finished my first lymphoma treatment between 3 and 24 months ago.

Lymphoma Survivors Phase 1 and 2: Clinically significant FCR (score of ≥ 16 on the validated FCR Inventory-Severity Subscale [FCRI-SS)

I am in complete remission from lymphoma after my first treatment.

Exclusion Criteria

Our study will exclude members of the following special populations: Prisoners

I do not have untreated mental health conditions like psychosis, bipolar, or borderline personality disorder.

I do not have untreated mental health conditions like psychosis, bipolar, or borderline personality disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development

Development of the UPLYFT program based on feedback from clinicians and a field test with lymphoma survivors

Varies

Intervention

Lymphoma survivors participate in the finalized UPLYFT program consisting of 6 weekly sessions

6 weeks

6 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in psychological inflexibility, depression, fear of cancer recurrence, quality of life, and anxiety

Up to 6 months

What Are the Treatments Tested in This Trial?

Interventions

• UPLYFT

Trial Overview UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence Therapy) is being tested. It's an intervention designed to help lymphoma survivors improve their quality of life by providing information on survivorship and tools to manage worries about the disease returning.

How Is the Trial Designed?

Group I: UPLYFT Pilot Experimental Treatment 1 Intervention

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.

Group II: Lymphoma Survivors Field Test Experimental Treatment 1 Intervention

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.

Group III: Clinicians Interviews Experimental Treatment 1 Intervention

Lymphoma and mental health clinicians will participate in 1x in-depth qualitative interview to provide feedback for the development of the UPLYFT program.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

American Society of Hematology

Collaborator

Trials

14

Recruited

20,800+

Published Research Related to This Trial

The all-oral chemotherapy regimen TEPIP was well-tolerated and showed a 23% overall response rate in 35 patients with advanced aggressive B-cell lymphoma, indicating its potential as a palliative treatment option.

Adding rituximab significantly improved the overall response rate to 67%, highlighting the benefit of combination therapy in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

All-Oral Low-Dose Chemotherapy TEPIP is Effective and Well-Tolerated in Relapsed/Refractory Patients With Aggressive B-Cell Lymphoma. Fante, MA., Felsenstein, M., Mayer, S., et al.[2022]

In patients with early treatment failure (ETF) in follicular lymphoma, autologous hematopoietic stem cell transplantation (auto-HCT) shows a promising 5-year overall survival rate of 70%, indicating its efficacy as a treatment option for this high-risk group.

Matched sibling donor (MSD) transplantation results in lower relapse rates compared to auto-HCT, but both have similar overall survival rates, suggesting that while MSD may reduce the chance of cancer returning, auto-HCT remains a viable option with low non-relapse mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous transplantation versus allogeneic transplantation in patients with follicular lymphoma experiencing early treatment failure. Smith, SM., Godfrey, J., Ahn, KW., et al.[2020]

In a study of 47 patients with aggressive lymphoma, 96% achieved complete remission after receiving a combination chemotherapy regimen (Pro-MACE-MOPP) followed by radiation therapy, with a median follow-up of 42 months and no relapses reported.

The treatment was found to be safe, with only 5% of chemotherapy cycles requiring hospital admissions for complications and no treatment-related deaths, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of localized aggressive lymphomas with combination chemotherapy followed by involved-field radiation therapy. Longo, DL., Glatstein, E., Duffey, PL., et al.[2017]

In a study of 26 patients with aggressive B-cell non-Hodgkin lymphoma who remained FDG-PET positive after R-CHOP chemotherapy, radical radiotherapy (RT) showed the highest 3-year progression-free survival (PFS) rate of 51%, compared to 25% for autologous stem cell transplant (ASCT) and 20% for non-radical treatments.

The overall survival (OS) rates were also better for patients receiving RT, with a 3-year OS of 65%, indicating that radiotherapy is an effective salvage treatment option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of salvage treatment modalities in patients with positive FDG-PET/CT after R-CHOP chemotherapy for aggressive B-cell non-Hodgkin lymphoma. Chin, V., Fulham, M., Hertzberg, M., et al.[2019]

About 16.3% of lymphoma patients experienced severe fear of cancer recurrence (FCR) after completing treatment, which was linked to a significantly higher risk of all-cause mortality (hazard ratio of 2.52) and lymphoma-specific mortality (hazard ratio of 2.62).

Patients with severe FCR reported worse quality of life, including lower scores in general health and various functioning areas, indicating that managing FCR is crucial for improving patient outcomes post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of fear of cancer recurrence on survival among lymphoma patients. Kim, SJ., Kang, D., Kim, IR., et al.[2020]

The targeted eHealth intervention 'FoRtitude' significantly reduced fear of recurrence (FoR) in breast cancer survivors, with scores decreasing from an average of 53.1 to 41.9 after the intervention, indicating its efficacy in addressing this prevalent concern.

Telecoaching enhanced participant adherence to the program and reduced dropout rates, suggesting that remote support can improve engagement in eHealth interventions for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted eHealth Intervention to Reduce Breast Cancer Survivors' Fear of Recurrence: Results From the FoRtitude Randomized Trial. Wagner, LI., Tooze, JA., Hall, DL., et al.[2022]

Approximately 50% of cancer survivors experience moderate to severe fear of progression, which can negatively impact their well-being and quality of life.

Targeted interventions, such as brief group therapy, have been shown to effectively treat clinical fear of progression in cancer patients, highlighting the need for psychological support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear of Progression in Cancer Patients and Survivors. Dinkel, A., Herschbach, P.[2019]

The ConquerFear intervention significantly reduced fear of cancer recurrence (FCR) in breast and colorectal cancer or melanoma survivors, showing greater improvements compared to a control group after therapy and maintaining these benefits for up to 6 months.

Participants in the ConquerFear group experienced not only lower FCR scores but also improvements in general anxiety, cancer-specific distress, and mental quality of life, indicating a broad positive impact on psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of ConquerFear: A Novel, Theoretically Based Psychosocial Intervention for Fear of Cancer Recurrence. Butow, PN., Turner, J., Gilchrist, J., et al.[2017]

In a study of 46 patients with relapsed or refractory B-cell lymphoma, the combination treatment of rituximab, gemcitabine, and oxaliplatin (R-GemOx) resulted in an impressive overall response rate of 83%, with 50% achieving complete or unconfirmed complete responses after four cycles.

R-GemOx demonstrated acceptable toxicity and promising long-term outcomes, with a 2-year overall survival rate of 66% and a 2-year event-free survival rate of 43%, making it a viable option for patients not eligible for high-dose therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rituximab, gemcitabine and oxaliplatin: an effective salvage regimen for patients with relapsed or refractory B-cell lymphoma not candidates for high-dose therapy. El Gnaoui, T., Dupuis, J., Belhadj, K., et al.[2022]

Fear of cancer recurrence or progression is a common and significant concern for cancer patients, impacting their quality of life and emotional well-being.

Early recognition and support for this fear, along with referrals to psychosocial oncology, can improve patient outcomes and help identify those at risk during key points in their treatment journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fear of Cancer Recurrence or Progression: What Is It and What Can We Do About It? Bergerot, CD., Philip, EJ., Bergerot, PG., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05080166

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 ...

2. dana-farber.org dana-farber.org/clinical-trials/21-409

An Intervention for Fear of Cancer Recurrence ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7159999/

Fear of Cancer Recurrence in Lymphoma Survivors Fear of cancer recurrence (FCR) is a common experience among cancer survivors and often persists after the termination of cancer treatments.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11953567/

Fear of Cancer Recurrence and Associated Factors in ... We observed high FCR levels in over half the survivors with lymphoma and a higher FCR risk in patients with anxiety, poor QoL and caregiver FCR.

5. ascopubs.org ascopubs.org/doi/10.1200/EDBK_100031

Fear of Cancer Recurrence or Progression: What Is It and ... Fear of cancer recurrence or progression has been associated with impaired quality of life and psychosocial adjustment, elevated emotional distress, and a ...

6. trialx.com trialx.com/clinical-trials/listings/246803/uplyft-for-lymphoma-survivors/

UPLYFT For Lymphoma Survivors | Clinical Research Trial ... The main purpose of this study is to field test and pilot an intervention called UPLYFT (Understand and Prevail: Lymphoma Fear of Recurrence ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735817305640

Fear of cancer recurrence: A qualitative systematic review ... Fear of cancer recurrence (FCR) is a significant issue for most cancer survivors, with nearly half of cancer survivors reporting it at moderate to high levels ...