Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

NCT ID: NCT04480008

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2021-12-27

Brief 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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Resilient Living Program

All participants will be in the Resilient Living Program arm. Study participation involves participating in a 12-week stress management and resilience training program. This will involve four virtual sessions (video or phone) and answering questions about their health, well-being, and quality of life. There will also be online modules to watch and an accompanying journal (with prompts) to keep.

Group Type: EXPERIMENTAL

Resilient Living Program

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Deirdre R. Pachman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deirdre R. Pachman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2021-02776

Identifier Type: REGISTRY

Identifier Source: secondary_id

19-011510

Identifier Type: -

Identifier Source: org_study_id