Virtual Group Resilient Living Program For Patients Living With Advanced Cancer

This study is a prospective, minimal risk, non-randomized, single-arm study to determine feasibility and assess effectiveness of a Virtual Group Resilient Living Program (RLP) on anxiety, stress, quality of life (QOL), coping, and fatigue among patients with advanced cancer. The group RLP is a psychosocial intervention that consists of a total of 7 weekly sessions in which the interventionalist teaches the patients techniques on stress management and building resilience (mindfulness, uplifting emotions, reframe experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness). The group setting allows for support and connection amongst the patients, providing further support and motivation to practice the principles of the program.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: Virtual Group Resilient Living Program (RLP); Other: Survey Completion

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Principal Investigator: Deirdre R. Pachman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English fluency
• Diagnosis of advanced (stage III/IV) malignancy
• Baseline distress score ≥ 4/10. Patients can answer questions orally rather than complete worksheet, if applicable
• Life expectancy of ≥ 6 months
• Provide informed consent
• Ability to complete questionnaire(s) by themselves or with assistance
• Has a reliable internet connection
• Has the ability to utilize technology to watch online modules, & participate in virtual sessions

Exclusion Criteria:

• As determined through self-report, those diagnosed with a history of a psychotic episode ≤ 5 years
• All psychological co-morbidities such as a history of untreated schizophrenia, & bipolar disease
• A diagnosis of severe cognitive impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Group Resilient Living Program; Participants will receive an invitation to 7 weekly 90-minute group RLP sessions. Study participation involves attending RLP sessions, and completing brief surveys related to health, well-being, and quality of life. There will also be online modules to watch and an accompanying journal (with prompts) to keep.

Behavioral: Virtual Group Resilient Living Program (RLP); The Resilient Living Program (RLP) is a virtual program consisting of online modules and virtual training sessions focused on techniques for managing stress and building resilience (mindful presence, uplifting emotions, and reframing experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness).; Other Names: RLP; Other: Survey Completion; Participants will complete study-related surveys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment Feasibility	Enrollment feasibility will be met if 42 patients are enrolled within a year.	Up to 1 year
Completion Feasibility	Completion feasibility will be met if at least 32 of 42 patients (≥75%) enrolled in the intervention arm attend at least 4 of the 7 program sessions.	Up to 1 year
Acceptability - Was it Worth it (WIWI)	measured by the three item responses from the Was It Worth It (WIWI) questionnaire. Acceptability will be met if at least 75% of respondents answer "Yes" to at least two out of the three items	After week 7 session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anxiety - GAD-7	Measured using the General Anxiety Disorder 7-item (GAD 7) scale, which is used to assess symptoms and feelings of anxiety over the past two weeks. The GAD-7 consists of 7 questions answered on a scale of 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21 where 0 indicates no anxiety, 1-4 indicates minimal anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety.	Baseline, after week 7 session, 30 days after week 7 session
Change in Stress - PSS	Measured using the 10-item Perceived Stress Scale (PSS), which is used to assess global perceived stress experienced by the participant over the preceding 30 days. The PSS consists of 10 questions assessing how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).	Baseline, after week 7 session, 30 days after week 7 session
Change in Quality of Life (QoL) - FACT-G	Measured using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire used to assess health-related quality of life (HRQoL) in cancer patients. Responses to each question are scored on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Possible total scores range from 0-108, with higher scores indicating a better outcome/better QoL.	Baseline, after week 7 session, 30 days after week 7 session
Change in Coping - Brief COPE	Measured using the Brief COPE (Coping Orientation to Problems Experienced), a 28-item questionnaire used to assess the different coping styles a person uses to manage stress. Each items is answered on a scale of 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). The Brief COPE consists of 14 subscales, i.e. active coping, planning, positive reframing, acceptance, humour, religion, use of emotional support, use of instrumental support, self-distraction, denial, venting, substance use, behavioral disengagement, and self-blame, with two items per sub-scale. Scores on each subscales ranges from 2 to 8 with higher scores representing most-used coping styles. There is no overall composite score for this questionnaire.	Baseline, after week 7 session, 30 days after week 7 session
Change in Fatigue - PROMIS-Fatigue	Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue questionnaire, a subscale of the PROMIS-29, which is used to assess fatigue and related symptoms over the past seven days. It consists of four items rated on a scale of 1(not at all) to 5 (very much). Higher scores indicate greater experiences of fatigue.	Baseline, after week 7 session, 30 days after week 7 session

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Deirdre R. Pachman, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Estimated): June 19, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MC250905; 25-011765 (Other Identifier: Mayo Clinic Institutional Review Board); MNCCTN043 (Other Identifier: Minnesota Cancer Clinical Trials Network)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No