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CancerNCT03640325

The PRISM Intervention for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation

A study testing PRISM (Promoting Resilience in Stress Management) in people with Cancer and Bone Marrow Neoplasms, run by Seattle Children's Hospital at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Multisite Randomized Controlled Trial (RCT) testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults receiving hematopoietic cell transplantation for hematology malignancy. Read more about this study

Who is it for?
Ages 12 to 24 years
Conditions the study is for
Cancer, Bone Marrow Neoplasms, Anxiety
What is being tested?
PRISM (Promoting Resilience in Stress Management)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
5 sitesUnited States
Study dates
1 Apr 2019to 31 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • AYA Child of caregiver agreed to participate
  • One caregiver per patient-caregiver dyad
  • Parent/guardian cognitively and physically able to participate
  • Parent/guardian is able to speak/read English or Spanish

Who cannot join

  • Patient refusal
  • Cognitively or physically unable to participate in interviews
  • Unable to speak English
  • Unable to read English or Spanish
  • For enrolled caregivers of AYA patient (no age limit):

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35233

  • Dana-Farber/Harvard Cancer Center

    Boston, Massachusetts, 02215

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

  • Seattle Children's Hospital Cancer and Blood Disorders Center

    Seattle, Washington, 98145

Other trials in United States

About this study

Official title: The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation

Multisite Randomized Controlled Trial (RCT) testing the efficacy of the Promoting Resilience in Stress Management (PRISM) intervention among Adolescents and Young Adults receiving hematopoietic cell transplantation for hematology malignancy.

Read the detailed description

The experience of hematopoietic cell transplantation (HCT) for malignancy or cancer predisposition among Adolescents and Young Adults (AYAs) is particularly difficult because age-related developmental challenges of identity, relationships, and vocation may add to the burden of cancer. Compared to other age-groups, AYAs have poorer psychosocial outcomes including increased anxiety and depression and poorer adherence to oral immunosuppressive medications. These outcomes may, in turn, predispose AYAs to disease-related morbidity and mortality such as graft-versus-host disease (GVHD) and/or cancer-relapse. A potential barrier to improving these experiences may be that AYAs have few opportunities to develop the personal resources needed to handle adversity. We have previously developed the "Promoting Resilience in Stress Management" (PRISM) intervention for AYAs with serious illness. This manualized, brief intervention is delivered in 4, 30-60 minute, one-on-one sessions, followed by a Parent/ Caregiver/ Spouse/ significant other inclusive meeting. It targets skills in stress-management and mindfulness, goal-setting, positive reframing, and meaning-making. All of these skills are associated with improved patient well-being in other populations, and preliminary findings from a recently closed phase II randomized controlled trial among AYAs with newly diagnosed cancer suggest PRISM is associated with improved health-related quality of life. This study will build on our prior experience and fill a critical knowledge gap regarding PRISM's impact among AYAs receiving HCT. Thus, we will conduct a multi-site randomized controlled trial with the primary trial outcome of patient-reported symptoms of anxiety and depression. Secondary and exploratory outcomes will include the cost-effectiveness of the intervention in this population, the impact of the intervention on parent well-being, and patient adherence to oral graft-versus-host-disease medications. We hypothesize that AYAs who receive PRISM will report fewer mixed affective symptoms, while their parents report improved quality of life and psychological distress. We also anticipate the intervention will positively impact adherence and be cost-effective. In sum, this study offers an opportunity to expand the body of knowledge regarding methodologically rigorous and evidence-based psychosocial interventions and standards of care for AYAs with hematologic malignancies. Ultimately, this research has the potential to reduce the burden of cancer in these vulnerable populations.

Being tested
PRISM (Promoting Resilience in Stress Management)
Medical subject headings
Neoplasms, Bone Marrow Neoplasms, Anxiety Disorders, Depression, Medication Adherence, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRISM (Promoting Resilience in Stress Management)Behavioural

    Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making

Study groups in NCT03640325
Study groupRoleWhat they receive
PRISM (Promoting Resilience in Stress Management)ExperimentalResilience Skills Training
Receives: Behavioral: PRISM (Promoting Resilience in Stress Management)
Usual CareNo interventionUsual psychosocial care (control arm, no intervention)
CaregiversNo interventionCaregivers of participants, no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score

    The Hospital Anxiety and Depression Scale -Depression sub scale assesses mixed affective symptoms in patients with serious illness. The scale consists of 7 questions for depression. Each is scored from 0-3, for a total range of 0-21 points. "Caseness" of depression is defined as ≥8 points, with sensitivity/specificity of 0.8/0.8 for depression. The depression sub-scale will be measured as a continuous variable. Higher scores indicate more symptoms.

    Measured: 6-months

Secondary outcomes (7)

  1. PedsQL Generic Core and Cancer-Related Quality of Life Score

    The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life of adolescents and young adults (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.

    Measured: 6-months

  2. Connor-Davidson Resilience Scale

    The Connor-Davidson Resilience Scale (CD-RISC) measures inherent resiliency. The 10-item instrument has high internal consistency. Each item consists of a 5-point Likert scale (scored from zero to four). ranging from 0-40 with higher scores reflecting greater perceived resilience.

    Measured: 6-months

  3. Hope Scale Scores

    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.

    Measured: 6-months

  4. Hospital Anxiety & Depression Scale Score - Anxiety Sub-score

    The Hospital Anxiety and Depression Scale - Anxiety sub scale assesses mixed affective symptoms in patients with serious illness. It consists of 7 questions on a 3 point Likert scale for a total range of 0-21. Higher scores indicate higher anxiety.

    Measured: 6-months

  5. Generalized Anxiety Disorder Screener (GAD7)

    7-item survey used to assess anxiety symptoms. Scored from 0-21 with higher scores indicated higher anxiety.

    Measured: 6-months

  6. Patient Health Questionnaire-8

    8-item survey assessing depression severity. Each item scored on a 4-point Likert scale with a range of 0-27. Higher scores indicate higher depression.

    Measured: 6-months

  7. Medical Outcomes Study Rand 36-item Health Survey

    This is a measure of health-related quality of life. Scores range from 0-100 and higher scores indicate better health status

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2018
  2. Study start1 Apr 2019
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2024

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03640325
Sponsor's protocol ID
STUDY00001077 (SC-N126)
Other IDs
R01CA225629
Status last verified
Oct 2024
First submitted
15 Aug 2018
Last updated
26 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All IPD will be protected and maintained by the study team

Publications

  • Taylor MR, Cole SW, Bradford MC, Zhou C, Fladeboe KM, Knight JM, Baker KS, Yi-Frazier JP, Rosenberg AR. Resilience Intervention Improves Stress-Related Gene Expression in Adolescent and Young Adult HCT Recipients. Transplant Cell Ther. 2024 Dec;30(12):1209.e1-1209.e7. doi: 10.1016/j.jtct.2024.09.014. Epub 2024 Sep 19.

    PubMed 39303988

  • Fladeboe KM, Scott S, Comiskey L, Zhou C, Yi-Frazier JP, Rosenberg AR. The Promoting Resilience in Stress Management (PRISM) intervention for adolescents and young adults receiving hematopoietic cell transplantation: a randomized controlled trial protocol. BMC Palliat Care. 2022 May 19;21(1):82. doi: 10.1186/s12904-022-00966-9.

    PubMed 35585525

Questions about this trial

What is this clinical trial studying?

A study testing PRISM (Promoting Resilience in Stress Management) in people with Cancer and Bone Marrow Neoplasms, run by Seattle Children's Hospital at 5 sites 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 4 inclusion and 5 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hospital Anxiety & Depression Scale (HADS) Score - Depression Sub-score (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03640325, which also lists 2 linked publications.

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 26 Oct 2024.

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