Virtual Group Resilient Living Program For Patients Living With Advanced Cancer
ConditionAdvanced Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Virtual Group Resilient Living Program (RLP)
BehavioralThe 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).
Survey Completion
Other interventionParticipants will complete study-related surveys.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: Virtual Group Resilient Living ProgramExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Enrollment Feasibility
Enrollment feasibility will be met if 42 patients are enrolled within a year.
Time frame
Up to 1 year2
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.
Time frame
Up to 1 year3
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
Time frame
After week 7 sessionSecondary outcomes
1
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.
Time frame
Baseline, after week 7 session, 30 days after week 7 session2
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).
Time frame
Baseline, after week 7 session, 30 days after week 7 session3
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.
Time frame
Baseline, after week 7 session, 30 days after week 7 session4
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.
Time frame
Baseline, after week 7 session, 30 days after week 7 sessionSponsors and contacts
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Source ClinicalTrials.gov