Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resilient Living Program

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.

Primary outcomes

Change in Perceived Stress

Time frame: Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)

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.
Change in Anxiety

Time frame: Baseline; Week 5 (after 2nd session); Week 9 (after 4th session); Week 12 (one month after completing all sessions)

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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jul 21, 2020
Registry last updated: Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed