NCT07659158

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

June 15, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 19, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 15, 2026

Last Update Submit

June 30, 2026

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Change in Anxiety - GAD-7

    Baseline, after week 7 session, 30 days after week 7 session

  • Change in Stress - PSS

    Baseline, after week 7 session, 30 days after week 7 session

  • Change in Quality of Life (QoL) - FACT-G

    Baseline, after week 7 session, 30 days after week 7 session

  • Change in Coping - Brief COPE

    Baseline, after week 7 session, 30 days after week 7 session

  • Change in Fatigue - PROMIS-Fatigue

    Baseline, after week 7 session, 30 days after week 7 session

Study Arms (1)

Virtual Group Resilient Living Program

EXPERIMENTAL

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)Other: Survey Completion

Interventions

Virtual Group Resilient Living Program (RLP)BEHAVIORAL

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).

Also known as: RLP
Virtual Group Resilient Living Program
Survey CompletionOTHER

Participants will complete study-related surveys.

Virtual Group Resilient Living Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Study Officials

  • Deirdre R. Pachman, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 22, 2026

Study Start

June 19, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 2, 2026

Record last verified: 2026-06

Locations

US(1)