Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Fatigue

Neoplasms, Second Primary

Neoplastic Processes

Participants will be randomly assigned to 1 of 3 study groups. The study treatment participants get will be chosen by chance, like rolling the dice. Both participants and the study staff will know which treatment you were assigned:

Participants in the PI group will complete the educational sessions only.

Psychoeducational Intervention

This group will only take placebo capsules every day.

Open Label Placebo

This group will take the placebo capsules every day, as well as completing the educational sessions.

Psychoeducational Intervention+Placebo

Sriram Yennu, MD

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.

Primary Objectives:

1. 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:

1. 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

3. 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers	NCT06085716	Metastatic Canc... Fatigue	Psychoeducation... Open Label Plac... Psychoeducation...	18 Years -	M.D. Anderson Cancer Center
Combination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers	NCT06085716	Metastatic Canc... Fatigue	Psychoeducation... Open Label Plac... Psychoeducation...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for psychoeducational intervention+placebo