Advanced Cancer
Conditions
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.
Interventions
BEHAVIORALVirtual 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).
OTHERSurvey Completion
Participants will complete study-related surveys.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Feasibility | Up to 1 year | Enrollment feasibility will be met if 42 patients are enrolled within a year. |
| Completion Feasibility | Up to 1 year | 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. |
| Acceptability - Was it Worth it (WIWI) | After week 7 session | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety - GAD-7 | Baseline, after week 7 session, 30 days after week 7 session | 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. |
| Change in Stress - PSS | Baseline, after week 7 session, 30 days after week 7 session | 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). |
| Change in Quality of Life (QoL) - FACT-G | Baseline, after week 7 session, 30 days after week 7 session | 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. |
| Change in Coping - Brief COPE | Baseline, after week 7 session, 30 days after week 7 session | 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. |
| Change in Fatigue - PROMIS-Fatigue | Baseline, after week 7 session, 30 days after week 7 session | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORDeirdre R. Pachman, MD
Mayo Clinic
Outcome results
None listed