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Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04480008
Enrollment
50
Registered
2020-07-21
Start date
2020-07-15
Completion date
2021-12-27
Last updated
2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Cancer

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.

Interventions

BEHAVIORALResilient 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Perceived StressBaseline; 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 AnxietyBaseline; 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026