Treatment Development Study of the Promoting Resilience in Stress Management (PRISM) Intervention for Depression and Anxiety in Young Adults With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Participant Satisfaction
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for Participants:
- •18-39 years of age
- •Speak and comprehend English sufficiently to be able to complete study procedures and participate in the program in English*
- •Have been diagnosed with cancer or desmoid tumor at least 6 or more weeks ago
- •Currently receiving treatment or has completed treatment for cancer or desmoid tumor no more than 6 months ago
- •Score 10-24 (with question #9 not endorsed, or 0) on the PHQ-9 (Kroenke et al., 1999) or/and score 10-21 on the GAD-7 (Spitzer et al., 2006) during the initial screening assessment.
- •Participant
排除标准
- •Adults unable to consent, individuals who are not yet adults (age <18), pregnant women, and prisoners.
- •Individuals who score less than 10 on both PHQ-9 and GAD-
- •Individuals who are diagnosed with cancer less than 6 weeks at the time of screening (we will be able to approach them again after 6 weeks since diagnosis has passed), or those who completed treatment more than 6 months ago will also be ineligible for this study; they will be offered resources for support, if desired.
- •5) Individuals who report any suicidality (ideation, plan, and/or intent) on PHQ-9 screen (i.e., endorse anything more than 0 for question #9) at the time of the eligibility screening will also be excluded from the current study, and the appropriate safety measures and/or referral to a mental health provider will be made (see section 14.1 for more details on the procedure).
- •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
研究组 & 干预措施
PRISM Program
Participants will be enrolled and will complete study procedures as follows:
- Baseline visit with questionnaires.
- 6 weekly or bi-weekly remote or in-clinic, psychotherapy sessions with psychologist.
- Final questionnaires and post-study exit interview
干预措施: Promoting Resilience in Stress Management Program (Behavioral)
结局指标
主要结局
Participant Satisfaction
时间窗: 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.
Rate of PRISM Intervention Completion
时间窗: Up to 12 weeks
Feasibility is defined as 70% of PRISM sessions are completed by participants who start the study.
Rate of Study Assessment Completion
时间窗: Up to 12 weeks
Study feasibility is defined as 70% of all study assessments are completed by participants who complete PRISM sessions.
次要结局
- Questionnaires(Up to 12 weeks)
- mPRISM Phone Application Usage(Up to 12 weeks)
研究者
Samantha Bento
Principal Investigator
Dana-Farber Cancer Institute