Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

Advanced Cancer Clinical Trial

Official title:

Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

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
• 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
• 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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

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)

External Links

•   Mayo Clinic Clinical Trials