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The Promoting Resilience in Stress Management Intervention in Reducing Anxiety and Depression in Adolescents and Young Adults with Cancer Undergoing Donor Stem Cell Transplant

Trial Status: Active

This trial studies how well the Promoting Resilience in Stress Management (PRISM) intervention works in reducing anxiety and depression in adolescents and young adults with cancer who are undergoing a donor stem cell transplant. The PRISM intervention may help adolescents and young adults with cancer improve skills such as stress-management and mindfulness, goal-setting, positive reframing, and meaning-making, thereby reducing patient-reported symptoms of anxiety and depression.

Inclusion Criteria

  • PATIENTS: Patient aged 12-17 years: has signed informed assent and their parent/legal guardian has signed informed consent for study participation
  • PATIENTS: Patient aged 18-24 years: has signed informed consent for study participation
  • PATIENTS: Receiving allogeneic hematopoietic cell transplantation (HCT) for treatment of malignancy at Seattle Cancer Care Alliance (Seattle Children’s Hospital and Fred Hutchinson Cancer Research Center) or Children’s Hospital Los Angeles (CHLA) * Within 4 weeks of their HCT date (“day zero”) (if prior, their planned HCT date)
  • PATIENTS: Patient able to speak and read English language
  • PATIENTS: Patient able to read in the English or Spanish language
  • PATIENTS: Cognitively able to participate in interactive interviews
  • HRV COMPONENT ONLY: Patient able to speak and read in English
  • PATIENTS: Note: Concurrent parent participation is not required for adolescent and young adult (AYA) patient participation
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN SURVEY-COMPLETION: AYA child of parent or guardian agrees to participate in study
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN SURVEY-COMPLETION: AYA child participant provides verbal assent or verbal consent if 18 or over for parent or guardian to complete surveys
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN SURVEY-COMPLETION: One parent per patient parent dyad
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN SURVEY-COMPLETION: Parent/guardian cognitively and physically able to participate
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN SURVEY-COMPLETION: Parent/guardian is able to speak and read English or Spanish language
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN SURVEY-COMPLETION: Parent/guardian participant has signed informed consent for study participation
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN PRIM SESSION 5, "COMING TOGETHER": AYA agrees to participate in study
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN PRIM SESSION 5, "COMING TOGETHER": AYA randomized to PRISM intervention arm of study
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN PRIM SESSION 5, "COMING TOGETHER": AYA provides verbal assent or verbal consent if 18 or over for parent, caregiver, spouse, and/or significant other to be present during this session
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN PRIM SESSION 5, "COMING TOGETHER": Parent/caregiver/spouse/significant other is cognitively and physically able to participate
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN PRIM SESSION 5, "COMING TOGETHER": Parent/caregiver/spouse/significant other is able to speak and read in English or Spanish
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN PRIM SESSION 5, "COMING TOGETHER": Parent/caregiver/spouse/significant other participant has signed informed consent for study participation

Exclusion Criteria

  • PATIENTS: Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
  • PATIENTS: Cognitively or physically unable to participate in interactive interview
  • PATIENTS: Patient unable to speak in the English language
  • PATIENTS: Patient unable to read in the English or Spanish language
  • PATIENTS: Patient not receiving allogeneic HCT for treatment of malignancy
  • HRV COMPONENT ONLY: Patient does not speak and read in English
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN PRIM SESSION 5, "COMING TOGETHER": AYA refusal to participate
  • PARENTS, CAREGIVER, SPOUSES, OR SIGNIFICANT OTHERS TO PARTICIPATE IN PRIM SESSION 5, "COMING TOGETHER": Parent/guardian/caregiver/spouse/significant other participant is < 18 years of age

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Emily Elizabeth Johnston
Phone: 205-638-2120

California

Los Angeles
Children's Hospital Los Angeles
Status: ACTIVE
Contact: Hisham Abdel-Azim

Tennessee

Memphis
Saint Jude Children's Research Hospital
Status: ACTIVE
Contact: Deena Rachel Levine

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Contact: Abby Rachel Rosenberg
Phone: 206-987-6892

PRIMARY OBJECTIVES:

I. Evaluate the effect of Promoting Resilience in Stress Management (PRISM) compared to usual care on symptoms of anxiety and depression.

SECONDARY OBJECTIVES:

I. Evaluate PRISM’s impact on other key patient-reported outcomes 6-months following enrollment.

II. Evaluate the cost-effectiveness of the PRISM intervention.

III. Evaluate the impact of PRISM on parent outcomes 6-months following enrollment.

IV. Describe individual and group 6-month trajectories for patient reported outcomes of usual care and PRISM participants.

EXPLORATORY OBJECTIVES:

I. Evaluate the effectiveness of PRISM compared to usual care in promoting adherence to oral GVHD prophylaxis.

II. Prospectively describe associations between PRISM, patient reported anxiety and depression, and stress biomarkers.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive 4 PRISM one-on-one, in person sessions over 30-50 minutes approximately 1-2 weeks apart and a 5th session with caregiver. Participants may also receive “booster” contacts weekly over 10-20 minutes until 6 months from enrollment.

ARM II: Participants receive usual care.

Trial Phase Phase NA

Trial Type Supportive care

Lead Organization
Fred Hutch / University of Washington Cancer Consortium

Principal Investigator
Abby Rachel Rosenberg

  • Primary ID RG1001777
  • Secondary IDs NCI-2019-01557, SC-N126
  • Clinicaltrials.gov ID NCT03640325