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Resilient Living Program for Patients With Advanced Cancer and Their Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480008
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2020
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Deirdre R. Pachman, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Advanced Cancer Behavioral: Resilient Living Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Resilient Living Program for Patients With Advanced Cancer and Their Caregivers
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Perceived Stress [ Time Frame: Baseline ]
    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.

  2. Perceived Stress [ Time Frame: Week 5 (after 2nd intervention session) ]
    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.

  3. Perceived Stress [ Time Frame: Week 9 (after 4th intervention session) ]
    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.

  4. Perceived Stress [ Time Frame: Week 12 (one month after completing all intervention 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.

  5. Anxiety [ Time Frame: Baseline ]
    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.

  6. Anxiety [ Time Frame: Week 5 (after 2nd intervention session) ]
    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.

  7. Anxiety [ Time Frame: Week 9 (after 4th intervention session) ]
    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.

  8. Anxiety [ Time Frame: Week 12 (one month after completing all intervention 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480008


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Deirdre Pachman, MD Mayo Clinic
Additional Information:
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Responsible Party: Deirdre R. Pachman, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04480008    
Other Study ID Numbers: 19-011510
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms