Harnessing the Effect of an Open-Label Placebo on Fatigue in Cancer Survivors

Study Overview
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Brief Summary
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This research study is evaluating the usefulness of a placebo (a tablet with no active ingredients) on fatigue in cancer survivors.

Detailed Description
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Fatigue can be a problem for some people after cancer treatment. In clinical trials, placebos (tablets with no active ingredients) have been shown to improve symptoms of some medical conditions including fatigue. This study is being done to test the usefulness of taking placebos for improving cancer-related fatigue. In this study, the investigators are testing whether symptoms of fatigue will improve when people know they are taking a tablet with no active ingredients. This is a randomized study, which means the participant will be put into one of two groups. Because no one knows which of the study options is best, the participant will be 'randomized' into one of the two study groups. Randomization means that the participant will be put into a group by chance. It is like flipping a coin. Neither the participant nor the research doctor will choose what group he or she will be in. The participant will have an equal chance of being placed in each of the groups.

Official Title
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Harnessing the Effect of an Open-Label Placebo on Fatigue in Cancer Survivors

Conditions
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Fatigue in Cancer Survivors

Intervention / Treatment
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* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer survivor, with no evidence of active disease ≥18 years of age ≥6 months and <10 years post active treatment Reports being bothered by fatigue in the past month and has a score of <43 on FACIT-F. Able to read and write in English Exclusion Criteria: Being evaluated or likely to be evaluated for a medical cause of fatigue (e.g., anemia, hypothyroidism) during the study. (per provider report) Have indications of sleep apnea as assessed by Epworth Sleepiness scale score ≥10. Are receiving, or are likely to receive another intervention for the treatment of fatigue during the study period. (per provider report)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label Placebo<br>- Placebo Tablets-Twice a day for 3-4 weeks | Other: Placebo<br>* Open-label placebo<br>|
| No Intervention: NT-Control<br>- No Placebo Tablets | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale | 13-item self-report measure of fatigue | Change from baseline to Day 8, and from baseline to Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF) | 35-items self-report mood scale | Change from baseline to Day 22 | 
| Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale | 12-item HRQOL measure | Change from baseline to Day 22 | 
| Subjective Sense of Change on fatigue, readiness for exercise and quality of life | 3-item measure that asks participants to report changes to their level of fatigue, ability to engage in physical activity, and overall quality of life since the beginning of the research program. | Change from baseline to Day 8, and change from Baseline to Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue in Cancer Survivors