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| ID | Type | Description | Link |
|---|---|---|---|
| 25-011765 | Other Identifier | Mayo Clinic Institutional Review Board | |
| MNCCTN043 | Other Identifier | Minnesota Cancer Clinical Trials Network |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Deirdre R. Pachman, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Survey Completion | Other | Participants will complete study-related surveys. |
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| 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 |