CancerPhase 2NCT02340884
A Pilot RCT of the PRISM Intervention for AYAs With Cancer
A Phase 2 study testing Promoting Resilience In Stress Management (PRISM) in people with Cancer and Acute Lymphoblastic Leukemia, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults with Cancer Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients with diagnosis of new or recurrent cancer between 1 and 10 weeks… Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Cancer, Acute Lymphoblastic Leukemia, Lymphoma
- What is being tested?
- Promoting Resilience In Stress Management (PRISM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2015to 19 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13-25 years
- Patient aged 13-17 years: has signed informed assent and their parent/legal guardian has signed informed consent for study participation.
- Patient aged 18-25 years: has signed informed consent for study participation.
- Diagnosis of malignancy treated with chemotherapy and/or radiation therapy at Seattle Childrens Hospital (SCH)
- New diagnosis of malignancy within 1-10 weeks of enrollment
- New diagnosis of recurrent disease (after initial remission) within 1-10 weeks of enrollment
- Ability to speak and read English language
- Cognitively able to participate in interactive interviews
Who cannot join
- Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
- Cognitively or physically unable to participate in interactive interview
- Unable to speak and read English language
- Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible).
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults With Cancer
Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults with Cancer
Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those ages 13-17 (N=50); (2) those ages 18-25 (N=50).
Read more
Study Design: Pilot randomized controlled trial (RCT).
Primary Objective: To test the efficacy of the "Promoting Resilience in Stress Management" (PRISM) among Adolescents and Young Adults with cancer.
Primary Outcome: Change in patient-reported resilience (based on score of standardized Connor-Davidson Resilience Scale) at 6 months.
Secondary Outcomes:
- Patient-reported resilience at 2, 4, and 12 months
- Patient-reported self-efficacy, benefit-finding, psychological distress, quality of life, and health-behaviors at 6 and 12 months.
- Qualitative assessment of patient-reported goals at 6 and 12 months
- Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial outcomes
Study Duration: 3 years
Read the detailed description
The experience of serious illness among adolescents and young adults (AYAs) is unique because they face distinctive developmental challenges, transitions, and choices related to education, employment, identity, relationships and family. Age-specific interventions are needed to promote positive resources and outcomes. Resilience, for example, is a construct describing an individual's capacity to maintain psychological and/or physical well-being in the face of stress, and is a good candidate to buffer the negative effects of stress. While few studies have described positive outcomes in AYA patients with chronic disease, and fewer still have suggested mechanisms to promote resilience, evidence suggests promoting "resilience-resources" (e.g., stress-management and goal setting skills, meaning-making and positive-reframing of negative experiences), as a means to manage stress may be valuable.
We have previously described models and factors of resilience among AYAs with cancer as well as parents of children with cancer, and demonstrated that self-perceptions of resilience are strongly associated with outcomes. Through iterative pilot testing, we have successfully developed a novel, patient-centered resilience-based intervention, the "Promoting Resilience in Stress Management" (PRISM) intervention.
The overall goal of the PRISM intervention is to improve AYA self-perceived resilience, thereby reducing AYA distress, improving quality of life, and minimizing risky health behaviors. The brief format involves 4, 50-minute, one-on-one sessions approximately 2 weeks apart, plus a 5th, optional, family-inclusive session 2-4 weeks following session #4. These are complimented with age-specific handouts describing the skills and opportunities to practice them, as well as monthly "booster" sessions. Specifically, the intervention incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3) cognitive restructuring; and, 4) meaning-making/benefit finding.
Enrolled patients will be between 13 and 25 years-old with at least a 2 week history of new or recurrent malignancy. They will be randomized to receive the PRISM intervention or standard psychosocial supportive care. Patients in both groups will be invited to complete quantitative surveys at the time of enrollment and then 2-, 4-, 6-, and 12-months later. Participants will be compensated for their time.
The primary outcome of the study is self-perceived resilience, as measured by the Connor-Davidson Resilience Score, at 6-months post-enrollment. Secondary outcomes will assess resilience scores at 4, 6, and 12 months, as well as self-efficacy, anxiety, depression, benefit-finding, quality of life, goal-setting skills, and health behaviors at 6 and 12 months.
The study is anticipated to accrue a total of 100 patients over 2 years.
- Conditions
- Cancer, Acute Lymphoblastic Leukemia, Lymphoma, Sarcoma, Acute Myelogenous Leukemia, Brain Tumors
- Being tested
- Promoting Resilience In Stress Management (PRISM)
- Medical subject headings
- Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Sarcoma, Leukemia, Myeloid, Acute, Brain Neoplasms, Neoplasms, Germ Cell and Embryonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Resilience In Stress Management (PRISM)Behavioural
The brief format of the PRISM intervention involves 4, 50-minute, one-on-one sessions approximately 2 weeks apart, plus a 5th parent-inclusive session 2-4 weeks following session #4. These are complimented with age-specific handouts describing the skills and opportunities to practice them, as well as weekly (text- or email based) check-ins from study staff and in-person "booster" sessions once monthly. Specifically, the intervention incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3) cognitive restructuring; and, 4) meaning-making/benefit finding.
| Study group | Role | What they receive |
|---|---|---|
| PRISM | Experimental | Promoting Resilience In Stress Management Intervention (skills-based intervention designed to teach stress-management, goal-setting, cognitive reframing, and meaning-making skills) Receives: Behavioral: Promoting Resilience In Stress Management (PRISM) |
| Control | No intervention | Standard psychosocial supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Resilience
Measured: 6 months
Secondary outcomes (6)
Patient-Reported self-efficacy
Measured: 6 months
Patient-Reported benefit-finding
Measured: 6 months
Patient-Reported goal-setting skills
Measured: 6 months
Patient-Reported quality of life
Measured: 6 months
Patient-Reported health behaviors
Measured: 6 months
Patient-reported anxiety & depression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study start30 Jan 2015
- Primary completion19 Sep 2017
- Study completion19 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abby Rosenberg, Seattle Children's Hospital
- Investigators
- Abby R Rosenberg, MD, MS, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340884
- Sponsor's protocol ID
- SC-N114
- Status last verified
- Apr 2024
- First submitted
- 9 Jan 2015
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rosenberg AR, Zhou C, Bradford MC, Salsman JM, Sexton K, O'Daffer A, Yi-Frazier JP. Assessment of the Promoting Resilience in Stress Management Intervention for Adolescent and Young Adult Survivors of Cancer at 2 Years: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136039. doi: 10.1001/jamanetworkopen.2021.36039.
PubMed 34817581Steineck A, Barton KS, Bradford MC, Yi-Frazier JP, Rosenberg AR. Tincture of Time: The Evolution of Goals in Adolescents and Young Adults with Cancer. J Adolesc Young Adult Oncol. 2021 Dec;10(6):703-710. doi: 10.1089/jayao.2020.0223. Epub 2021 May 6.
PubMed 33960833Lau N, Bradford MC, Steineck A, Scott S, Bona K, Yi-Frazier JP, McCauley E, Rosenberg AR. Examining key sociodemographic characteristics of adolescents and young adults with cancer: A post hoc analysis of the Promoting Resilience in Stress Management randomized clinical trial. Palliat Med. 2020 Mar;34(3):336-348. doi: 10.1177/0269216319886215. Epub 2019 Nov 4.
PubMed 31680625Lau N, Bradford MC, Steineck A, Junkins CC, Yi-Frazier JP, McCauley E, Rosenberg AR. Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care. Psychooncology. 2019 Jul;28(7):1470-1476. doi: 10.1002/pon.5098. Epub 2019 May 14.
PubMed 31037789
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT02340884
- Acronym / sponsor ID
- SC-N114
- Conditions
- Cancer, Acute Lymphoblastic Leukemia, Lymphoma, Sarcoma, Acute Myelogenous Leukemia, Brain Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 30 Jan 2015 (actual)
- Primary completion
- 19 Sep 2017 (actual)
- Study completion
- 19 Dec 2021 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults with Cancer
Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those ages 13-17 (N=50); (2) those ages 18-25 (N=50).
Study Design: Pilot randomized controlled trial (RCT).
Primary Objective: To test the efficacy of the "Promoting Resilience in Stress Management" (PRISM) among Adolescents and Young Adults with cancer.
Primary Outcome: Change in patient-reported resilience (based on score of standardized Connor-Davidson Resilience Scale) at 6 months.
Secondary Outcomes:
- Patient-reported resilience at 2, 4, and 12 months
- Patient-reported self-efficacy, benefit-finding, psychological distress, quality of life, and health-behaviors at 6 and 12 months.
- Qualitative assessment of patient-reported goals at 6 and 12 months
- Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial outcomes
Study Duration: 3 years
Detailed description
The experience of serious illness among adolescents and young adults (AYAs) is unique because they face distinctive developmental challenges, transitions, and choices related to education, employment, identity, relationships and family. Age-specific interventions are needed to promote positive resources and outcomes. Resilience, for example, is a construct describing an individual's capacity to maintain psychological and/or physical well-being in the face of stress, and is a good candidate to buffer the negative effects of stress. While few studies have described positive outcomes in AYA patients with chronic disease, and fewer still have suggested mechanisms to promote resilience, evidence suggests promoting "resilience-resources" (e.g., stress-management and goal setting skills, meaning-making and positive-reframing of negative experiences), as a means to manage stress may be valuable.
We have previously described models and factors of resilience among AYAs with cancer as well as parents of children with cancer, and demonstrated that self-perceptions of resilience are strongly associated with outcomes. Through iterative pilot testing, we have successfully developed a novel, patient-centered resilience-based intervention, the "Promoting Resilience in Stress Management" (PRISM) intervention.
The overall goal of the PRISM intervention is to improve AYA self-perceived resilience, thereby reducing AYA distress, improving quality of life, and minimizing risky health behaviors. The brief format involves 4, 50-minute, one-on-one sessions approximately 2 weeks apart, plus a 5th, optional, family-inclusive session 2-4 weeks following session #4. These are complimented with age-specific handouts describing the skills and opportunities to practice them, as well as monthly "booster" sessions. Specifically, the intervention incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3) cognitive restructuring; and, 4) meaning-making/benefit finding.
Enrolled patients will be between 13 and 25 years-old with at least a 2 week history of new or recurrent malignancy. They will be randomized to receive the PRISM intervention or standard psychosocial supportive care. Patients in both groups will be invited to complete quantitative surveys at the time of enrollment and then 2-, 4-, 6-, and 12-months later. Participants will be compensated for their time.
The primary outcome of the study is self-perceived resilience, as measured by the Connor-Davidson Resilience Score, at 6-months post-enrollment. Secondary outcomes will assess resilience scores at 4, 6, and 12 months, as well as self-efficacy, anxiety, depression, benefit-finding, quality of life, goal-setting skills, and health behaviors at 6 and 12 months.
The study is anticipated to accrue a total of 100 patients over 2 years.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRISM | Experimental | Behavioral: Promoting Resilience In Stress Management (PRISM)Promoting Resilience In Stress Management Intervention (skills-based intervention designed to teach stress-management, goal-setting, cognitive reframing, and meaning-making skills) |
| Control | No intervention | –Standard psychosocial supportive care |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 13-25 years
- Diagnosis of malignancy treated with chemotherapy and/or radiation therapy at Seattle Childrens Hospital (SCH)
- Ability to speak and read English language
- Cognitively able to participate in interactive interviews
Key exclusion criteria (4 listed)
- Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
- Cognitively or physically unable to participate in interactive interview
- Unable to speak and read English language
- Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promoting Resilience In Stress Management (PRISM)The brief format of the PRISM intervention involves 4, 50-minute, one-on-one sessions approximately 2 weeks apart, plus a 5th parent-inclusive session 2-4 weeks following session #4. These are complimented with age-specific handouts describing the skills and opportunities to practice them, as well as weekly (text- or email based) check-ins from study staff and in-person "booster" sessions once monthly. Specifically, the intervention incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3) cognitive restructuring; and, 4) meaning-making/benefit finding. | Behavioural | PRISM |
Primary outcome
Patient-Reported Resilience
Time frame: 6 months
6 secondary outcomes
Patient-Reported self-efficacy
Time frame: 6 months
Patient-Reported benefit-finding
Time frame: 6 months
Patient-Reported goal-setting skills
Time frame: 6 months
Patient-Reported quality of life
Time frame: 6 months
Patient-Reported health behaviors
Time frame: 6 months
Patient-reported anxiety & depression
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 34817581Rosenberg AR, Zhou C, Bradford MC, Salsman JM, Sexton K, O'Daffer A, Yi-Frazier JP. Assessment of the Promoting Resilience in Stress Management Intervention for Adolescent and Young Adult Survivors of Cancer at 2 Years: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Nov 1;4(11):e2136039. doi: 10.1001/jamanetworkopen.2021.36039.
- Derived from this study: PubMed 33960833Steineck A, Barton KS, Bradford MC, Yi-Frazier JP, Rosenberg AR. Tincture of Time: The Evolution of Goals in Adolescents and Young Adults with Cancer. J Adolesc Young Adult Oncol. 2021 Dec;10(6):703-710. doi: 10.1089/jayao.2020.0223. Epub 2021 May 6.
- Derived from this study: PubMed 31680625Lau N, Bradford MC, Steineck A, Scott S, Bona K, Yi-Frazier JP, McCauley E, Rosenberg AR. Examining key sociodemographic characteristics of adolescents and young adults with cancer: A post hoc analysis of the Promoting Resilience in Stress Management randomized clinical trial. Palliat Med. 2020 Mar;34(3):336-348. doi: 10.1177/0269216319886215. Epub 2019 Nov 4.
- Derived from this study: PubMed 31037789Lau N, Bradford MC, Steineck A, Junkins CC, Yi-Frazier JP, McCauley E, Rosenberg AR. Exploratory analysis of treatment response trajectories in the PRISM trial: Models of psychosocial care. Psychooncology. 2019 Jul;28(7):1470-1476. doi: 10.1002/pon.5098. Epub 2019 May 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abby R Rosenberg, MD, MS principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Promoting Resilience In Stress Management (PRISM) in people with Cancer and Acute Lymphoblastic Leukemia, run by Seattle Children's Hospital at 1 site 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 8 inclusion and 4 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient-Reported Resilience (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 NCT02340884, which also lists 4 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 9 Apr 2024.