Anxiety, Anxiety Disorders, Cancer Diagnosis, Depression, Depression, Anxiety, Depressive Disorder, Desmoid, Non-Metastatic Neoplasm
Conditions
Keywords
Cancer Diagnosis, Non-Metastatic Neoplasm, Anxiety, Anxiety Disorders, Depression, Depression Disorder, Depression, Anxiety, Young adults with cancer, Desmoid tumor
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALPromoting Resilience in Stress Management Program
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.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
for Participants: 1. 18-39 years of age 2. Speak and comprehend English sufficiently to be able to complete study procedures and participate in the program in English\* 3. Have been diagnosed with cancer or desmoid tumor at least 6 or more weeks ago 4. Currently receiving treatment or has completed treatment for cancer or desmoid tumor no more than 6 months ago 5. 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
Exclusion criteria
1. Adults unable to consent, individuals who are not yet adults (age \<18), pregnant women, and prisoners. 2. Individuals who score less than 10 on both PHQ-9 and GAD-7. 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of PRISM Intervention Completion | 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 | Up to 12 weeks | Study feasibility is defined as 70% of all study assessments are completed by participants who complete PRISM sessions. |
| Participant Satisfaction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mPRISM Phone Application Usage | 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. |
| Questionnaires | Up to 12 weeks | The feasibility of using the assessment questionnaires in the current study (e.g., length, administration) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSamantha Bento, PhD
Dana-Farber Cancer Institute
STUDY_DIRECTORGreta J Khanna, PhD, MA
Dana-Farber Cancer Institute
Outcome results
None listed