Overview
To find out if combining psychoeducational interventions (such as education, counseling, and self-managed therapies) with an open-label placebo can help to improve your quality of life better than either the psychoeducational interventions or the placebo alone.
Description
Primary Objectives:
- To determine if the combination therapy of PI with OLP (combination therapy group) is superior to PI alone group in the treatment of cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.
We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF compared to PI alone.
Secondary Objectives:
- To determine if Combination Therapy group is superior to PI Only group for the treatment of CRF at 3 months and 6 months after treatment. We hypothesize that the combination of OLP+PI in these patients will result in a greater reduction of CRF after 3 months and 6 months after treatment
- To determine the effects of combination therapy on fatigue-related quality-of-life, mood, sleep-wake activity, cognitive measures, and inflammation. We will assess measures including quality of life (Functional Assessment of Cancer Therapy - General, FACT- G), multidimensional fatigue (Multidimensional Fatigue Symptom Inventory, MFSI-SF), sleep disturbance (PROMIS-sleep), anxiety (Hospital Anxiety and Depression Scale - HADS), depressed mood (HADS), cognitive function (Symbol digit modality test, SDMT), sleep/wake time activity (actigraphy), and inflammation (C-reactive protein levels).
We hypothesize that combination therapy will result in improvements in CRF-related quality of life, mood, sleep-wake activity, and cognitive measures.
Eligibility
Inclusion Criteria:
- Be advanced cancer patients (incurable metastatic), having fatigue with severity of 4/10, on a 0-10 scale (Edmonton Symptom Assessment Scale) for at least 2 weeks.
- Have no clinical evidence of cognitive failure as evidenced by treating clinician assessment at screening (Memorial Delirium Assessment Scale of less than 13/30).
- Be aged 18 years or older.
- Be willing to engage in follow-up in person or by telephone or virtual calls with research staff.
- Have a hemoglobin level of ≥10 g/dL within 2 weeks of enrollment.
- Be able to understand the description of the study and sign a written informed consent.
- Have a ECOG performance status score of 0 to 2; and
- Be seen at an outpatient clinic at MD Anderson Cancer Center's (MDA) main campus or its Houston Area Locations (HALs)
Exclusion Criteria:
- Have a major contraindication to placebo (e.g., allergy or hypersensitivity to study medications or their constituents), or conditions making adherence difficult as determined by the attending physician.
- Be unable to complete the baseline assessment forms or to understand the recommendations for participation in the study.
- Be pregnant or become pregnant while on study.