CLINICAL TRIAL

PRISM (Promoting Resilience in Stress Management) for Bone Marrow Neoplasms

Newly Diagnosed
Relapsed
Recruiting · < 65 · All Sexes · Memphis, TN

This study is evaluating whether a program which teaches stress management techniques may help improve the health of adolescents and young adults who have received a stem cell transplant.

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About the trial for Bone Marrow Neoplasms

Eligible Conditions
Depression · Malignancies · Bone Marrow Neoplasms · Quality of Life (QOL) · Adherence, Medication · Skills, Coping · Anxiety · Adolescent Behaviors

Treatment Groups

This trial involves 2 different treatments. PRISM (Promoting Resilience In Stress Management) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
PRISM (Promoting Resilience in Stress Management)
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Bone Marrow Neoplasms or one of the other 7 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patient aged 12-24 years
Receiving hematopoietic cell transplantation (HCT) for malignancy or cancer predisposition syndrome
Within 4 weeks of HCT "day zero"
Able to speak English
You must be able to read and write in English or Spanish. show original
Cognitively able to participate in interviews
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6-months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6-months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether PRISM (Promoting Resilience in Stress Management) will improve 1 primary outcome, 7 secondary outcomes, and 3 other outcomes in patients with Bone Marrow Neoplasms. Measurement will happen over the course of 6-months.

Impact of PRISM on oral adherence to GVHD medications
6-MONTHS
Exploratory aim: This study will use the medication electronic monitoring system (MEMS) monitoring device to evaluate real-time medication adherence. Participants will store prescriptions for their primary GVHD prophylaxis in study-dispensed MEMS bottles and caps. Digital data with each cap-opening will be tracked and matched to prescription records to evaluate adherence, with a threshold of >90% indicating adherent versus non-adherent behavior.
6-MONTHS
Parent Depression (PHQ-8 scores)
6-MONTHS
Parent Depression: This 8-item survey is scored on a 4-point Likert scale and the sum (0- 27) indicates the degree of depression, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe depression.
6-MONTHS
Hope Scale Scores
6-MONTHS
The Snyder "Hope" Scale measures "the overall perception that one's goals can be met." The instrument scored on an 8-point Likert scale (score range 0-64). Higher scores imply greater levels of hopeful thought patterns.
6-MONTHS
Cost-Effectiveness of PRISM intervention
6-MONTHS
The main cost-analyses will determine the total, per-patient, 6-month costs of PRISM versus usual care. Using Quality-adjusted life years (QALYs) we will then estimate the incremental cost-effectiveness ratio (ICER). QALYs will be calculated with Health Utilities Index scores. The HUI consists of 15 total queries to assess 2 systems; scoring is based on standard gamble utilities, with scores from 0 (health-state preference equivalent to death) to 1 (perfect health). Costs will be measured with a study-specific cost-of-care checklist adapted from consensus guidelines to track direct and indirect patient costs.
6-MONTHS
Connor-Davidson Resilience Scale
6-MONTHS
The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. Two items from the original 25-item CD-RISC were used to create a brief, 2-item scale (the CD-RISC2), namely items 1 ("Able to adapt to change") and 8 ("Tend to bounce back after illness or hardship"). Each item consists of a 5-point Likert scale (scored from zero to four). The 2-item scale has a total of 10 points, with higher scores reflecting greater perceived resilience.
6-MONTHS
PedsQL Generic Core and Cancer-Related Quality of Life Score
6-MONTHS
The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life of AYAs with cancer. Items are rated on a 5-point Likert scale and total scores transformed to a 0-100 scale with higher scores representing better HRQOL. Internal consistency ranges from 0.75 to 0.92.
6-MONTHS
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Who is running the study

Principal Investigator
A. R.
Prof. Abby Rosenberg, Associate Professor, Pediatrics
Seattle Children's Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is bone marrow neoplasms?

We found low prevalence in our series of malignant bone marrow diseases. Although malignant bone marrow infiltrate is found in over 50% of cases of hematological malignancies, this is not always diagnosed. We found that in only 3% of our cases we made the diagnosis of a specific bone marrow neoplasm.

Anonymous Patient Answer

What are the signs of bone marrow neoplasms?

These include anaemia, leucocytosis, thrombocytosis, and plasmacytosis. On the basis of the signs present, bone marrow neoplasms can be classified into three types: myeloid, lymphoid and histiocytic. Each type of bone marrow neoplasm also has its own unique differential diagnosis.

Anonymous Patient Answer

What are common treatments for bone marrow neoplasms?

The treatment of neoplasms of the bone marrow depends on the type of malignancy and its location and extent of infiltration. There is increasing emphasis on the use of autotransplantation for patients with hematological malignancies in whom the marrow has been damaged by radiation, or after myeloablative chemotherapy. Some tumors are amenable to curative surgical resection by a bone-seeking beam and are treated with radiation. Patients with solid tumors will receive neoadjuvant chemotherapy and then receive local therapy followed by radiation. Chemotherapy before the surgical procedure is usually contraindicated due to the severity, or refusal, of such therapy from patients.

Anonymous Patient Answer

What causes bone marrow neoplasms?

Bone malignancies are a group of neoplasms that are characterized by malignant proliferation of cells in the osseous tissues. They occur in adolescents and the elderly. In the adult population the occurrence of malignancies of bone marrow is less than 1%. The most frequent bone neoplasm is Ewing's sarcoma, and other tumors that cause skeletal pain often have a more ominous course and shorter survival. The malignancies originating in bone marrow have a higher degree of aggressiveness than those of brain. The histology of these neoplasms is varied and not always well defined.

Anonymous Patient Answer

Can bone marrow neoplasms be cured?

Tumor cells that may be disseminated are killed more than those of the same type in the peripheral blood, mainly because of tumor cell destruction, but also because tumor angiogenesis is reduced in the marrow compared with normal marrow.

Anonymous Patient Answer

How many people get bone marrow neoplasms a year in the United States?

Approximately 15,500 new cases of acute myeloid leukemia and 10,000 new cases of de novo acute myelomonocytic leukemia are diagnosed in the United States each year. About 5,900 new cases of chronic myeloid leukemia and 4,300 new cases of new chronic lymphocytic leukemia are diagnosed, and 1050 new cases of new chronic myelomonocytic leukemia are diagnosed. About 10,200 new cases of non-Hodgkin lymphoma and 8,500 new cases of Hodgkin lymphoma are diagnosed each year.

Anonymous Patient Answer

Does bone marrow neoplasms run in families?

A high percentage of families with BM neoplastic disease also had other hematologic conditions. We suggest that genetic predisposition is present for most hematologic disorders.

Anonymous Patient Answer

Does prism (promoting resilience in stress management) improve quality of life for those with bone marrow neoplasms?

Prism is a valuable intervention to aid coping with cancer and its treatment trajectory and has the potential to support improvement in the outcomes of patients.

Anonymous Patient Answer

What does prism (promoting resilience in stress management) usually treat?

For the treatment of stress, a low-dose aspirin plus daily exercise (prism) is preferred by patients to both an exercise-only (prism) intervention or treatment plus a placebo. It is recommended that patient education be supplemented with the use of an intervention such as prism tailored to the individual.

Anonymous Patient Answer

Have there been any new discoveries for treating bone marrow neoplasms?

The treatment of bone marrow neoplasms is continually evolving. The advancement and refinement of treatments are based on the discovery and development of new drugs and therapies with the aim of reducing the pain, treatment side effects, and enhancing the quality of life of the patients. Recent improvements in bone marrow transplantation therapy, especially those involving the use of the monoclonal antibody rituximab, such as 'Rituximab for Treatment of Poor Response in Cutaneous T-Cell Lymphoma' (Rituxan), have had a significant and substantial impact for improving the prognosis and survival of the patients.

Anonymous Patient Answer

How does prism (promoting resilience in stress management) work?

A placebo-controlled randomized prospective design to study short-term treatment (two therapy sessions) with the resilience-promotion intervention in patients evaluated for bone marrow transplantation. summary: Results from a recent paper is evaluating whether it is safe and effective to treat patients with bone marrow cancer by combining a couple of therapies.

Anonymous Patient Answer

How serious can bone marrow neoplasms be?

[Bone neoplasms account for roughly 7% of newly diagnosed malignancies in the United States, with myeloma being the most common. Myeloma and leukemia occur in children as infrequently as in adults] (http://www.neoplasmology.org/). If a child's [prognosis after the diagnosis of osteogenic sarcoma with a bone metastasis] is good, then the [average life span of the child with the primary tumour] can surpass [a decade]. However, if there is severe pain, [osseous sarcoma without bone metastasis] probably has a shorter prognosis, especially if there is a high amount of metastables.

Anonymous Patient Answer
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