Dana-Farber Cancer Institute
Brighton, Massachusetts, 02135, United States
NCT Number: NCT06502483
This research study is being done to test the feasibility of an existing supportive program (PRISM) to address psychological symptoms (i.e., depressive and anxiety symptoms) that young adult participants diagnosed with cancer or desmoid tumor may experience.
The name of the intervention used in this research study is:
-Promoting Resilience in Stress Management (PRISM) Program
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Notify Me18 year–39 year
All sexes
Interventional
Not applicable
Brighton, Massachusetts, 02135, United States
This research study is being done to test the initial feasibility and acceptability of a six-session, skills-based resilience coaching intervention, Promoting Resilience in Stress Management (PRISM; Rosenberg et al., 2018; Rosenberg et al., 2021), that targets four resilience resources (stress management, goal setting, cognitive reframing, and meaning-making) for young adult patients (18-30 years old) with cancer or desmoid tumor who are treated with curative intent and who report moderate depressive and/or anxiety symptoms.
The research study procedures include screening for eligibility, completing one diagnostic assessment of depressive and anxiety symptoms, pre-intervention and post-intervention questionnaires, completion of the six-session PRISM intervention, and a semi-structured exit interview about the experience with the PRISM intervention.
Participation in this research study is expected to last approximately 2 to 3 months.
It is expected that up to 15 young adults with cancer (i.e., participants) and up to a total of 15 support persons (i.e., friends or family members who participants will have an option to invite for the final session of the intervention) will take part in this research study.
The Hans and Mavis Lopater Foundation is funding this research study by providing philanthropic support.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Participants:
Participant Exclusion Criteria:
Inclusion criteria
for Support Person:
-≥ 18 years of age
-A friend or family member invited by the study participant to join the 6th PRISM session
Promoting Resilience in Stress Management (PRISM; Rosenberg et al., 2018; Rosenberg et al., 2021) is is an evidence-based skills-based resilience intervention. In the current study, PRISM sessions with be facilitated by a trained mental health provider to equip participants with skills for coping with anxiety, low mood, and adjustment to cancer diagnosis and to target four resilience resources (i.e., stress management, goal setting, cognitive reframing, and meaning-making). Sessions will be conducted by phone or Zoom, a HIPAA-compliant telemedicine platform. The optional mPRISM phone application includes 6 modules to practice PRISM skills and is available for iOS/Android.
Other names: PRISM Program
Time frame: Up to 12 weeks
Feasibility is defined as 70% of PRISM sessions are completed by participants who start the study.
Time frame: Up to 12 weeks
Study feasibility is defined as 70% of all study assessments are completed by participants who complete PRISM sessions.
Time frame: At final intervention session, up to 6 weeks
Acceptability of the PRISM intervention will be determined by responses on semi-structured exit interviews using descriptive statistics and scores on the Client Satisfaction Questionnaire- (CSQ-8), an 8-item measuring a participant's opinions and assessment of the intervention. Total scores range from 8 to 32 with a higher number indicating greater satisfaction.
Time frame: Up to 12 weeks
The feasibility of the mPRISM phone application as a tool to practice PRISM skills, as evidenced by the participant usage metrics.
Time frame: Up to 12 weeks
The feasibility of using the assessment questionnaires in the current study (e.g., length, administration)
Dana-Farber Cancer Institute
Other
Treatment Development Study of the Promoting Resilience in Stress Management (PRISM) Intervention for Depression and Anxiety in Young Adults With Cancer
Acronym: PRISM
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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