The Promoting Resilience in Stress Management (PRISM) Intervention: a Multi-site Randomized Controlled Trial for Adolescents and Young Adults Receiving Hematopoietic Cell Transplantation
Status: | Recruiting |
---|---|
Conditions: | Anxiety, Anxiety, Cancer, Cancer, Depression, Psychiatric |
Therapuetic Areas: | Oncology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 12 - 24 |
Updated: | 3/23/2019 |
Start Date: | February 1, 2019 |
End Date: | July 1, 2023 |
Contact: | Abby R Rosenberg, MD, MS, MA |
Email: | abby.rosenberg@seattlechildrens.org |
Phone: | 206-987-2106 |
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.
in Stress Management (PRISM) intervention among Adolescents and Young Adults receiving
hematopoietic cell transplantation for hematology malignancy.
The experience of hematopoietic cell transplantation (HCT) for hematologic malignancy 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 among N=70 AYAs (n=35 PRISM and n=35 usual care; ages 12-24
years), with the primary trial outcome of patient-reported symptoms of anxiety and
depression. Secondary outcomes will include the cost-effectiveness of the intervention in
this population and the impact of the intervention on parent well-being. Exploratory outcomes
will assess patient adherence to oral chemotherapy. We hypothesize that AYAs who receive
PRISM will report fewer mixed affective symptoms and demonstrate better adherence, while
their parents report improved quality of life and psychological distress. We also anticipate
the intervention will 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.
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 among N=70 AYAs (n=35 PRISM and n=35 usual care; ages 12-24
years), with the primary trial outcome of patient-reported symptoms of anxiety and
depression. Secondary outcomes will include the cost-effectiveness of the intervention in
this population and the impact of the intervention on parent well-being. Exploratory outcomes
will assess patient adherence to oral chemotherapy. We hypothesize that AYAs who receive
PRISM will report fewer mixed affective symptoms and demonstrate better adherence, while
their parents report improved quality of life and psychological distress. We also anticipate
the intervention will 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.
Inclusion Criteria:
- Patient aged 12-24 years
- Receiving allogeneic hematopoietic cell transplantation (HCT) at Seattle Cancer Care
Alliance or Children's Hospital Los Angeles
- 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:
- Patient refusal
- Cognitively or physically unable to participate in interviews
- Unable to speak English
- Unable to read English or Spanish
- Not receiving allogeneic HCT for treatment of malignancy
We found this trial at
2
sites
Seattle, Washington 98145
Principal Investigator: Abby R Rosenberg, MD, MS, MA
Phone: 206-987-2106
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