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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04480008
Other study ID # 19-011510
Secondary ID NCI-2021-02776
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2020
Est. completion date December 27, 2021

Study information

Verified date January 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are trying to find out if the Resilient Living Program will improve quality of life, stress, anxiety, sleep, fatigue, and resilience in patients with advanced cancer and their caregivers.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 27, 2021
Est. primary completion date December 27, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for patients: - Age =18 years - English fluency - No diagnosed severe cognitive impairment - Diagnosis of stage IV solid tumor cancer - Expected prognosis >6 <18 months - Provide written informed consent - Ability to complete questionnaire(s) by themselves or with assistance - Patient baseline distress score =4/10 OR identified as having distress that would benefit from program by care team or provider - Ability to do first Resilient Living session in person Inclusion Criteria for caregivers: - Self-identifies as a caregiver of a patient that meets the above cancer diagnosis criteria, and who also participates in the study - Provide written informed consent - Ability to complete questionnaire(s) by themselves or with assistance - Age =18 years - English fluency - No diagnosed severe cognitive impairment - Ability to do first Resilient Living session in person Exclusion Criteria: - As determined through self-report, those diagnosed with a history of a psychotic episode will be excluded. - Other psychological co-morbidities such as untreated schizophrenia, bipolar disease

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Resilient Living Program
Participants will be given the journal Resilient Living with Dr. Sood: Building Strength for Difficult Days to use throughout the study. The initial session with one of the investigators will be an introduction and a review of Module 1: Gratitude, and will last 30-60min. Three follow-up sessions will occur approximately every two weeks and the participants should view the videos before those virtual meetings (Session 2 will review Module II: Mindful Presence; Session 3 will review Module III: Kindness; Session 4 will review Module IV: Resilient Mindset). The videos will take approximately 30 minutes each to review and virtual sessions will each take 30-60 minutes.

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Perceived Stress Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level. Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)
Primary Change in Anxiety Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety. Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)
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