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Completed

NCT Number: NCT03640325

The PRISM Intervention 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.

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Key information

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for adolescent/young adult (AYA) patient:

  • 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
  • Able to read English or Spanish
  • Cognitively able to participate in interviews

Exclusion criteria

for AYA patient:

  • 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):

Inclusion criteria

  • 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

Treatment and study plan

PRISM (Promoting Resilience in Stress Management)

Behavioral

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

Primary outcomes

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

    Time frame: 6-months

    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.

Secondary outcomes

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

    Time frame: 6-months

    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.

  2. Connor-Davidson Resilience Scale

    Time frame: 6-months

    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.

  3. Hope Scale Scores

    Time frame: 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.

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

    Time frame: 6-months

    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.

  5. Generalized Anxiety Disorder Screener (GAD7)

    Time frame: 6-months

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

  6. Patient Health Questionnaire-8

    Time frame: 6-months

    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.

  7. Medical Outcomes Study Rand 36-item Health Survey

    Time frame: 6-months

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

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Children's Hospital Los Angeles
  • National Cancer Institute (NCI)
  • St. Jude Children's Research Hospital
  • University of Alabama at Birmingham

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
Aug 21, 2018
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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