Clinical trial NCT02452710: Harnessing the Effect of an Open-Label Placebo on Fatigue in Cancer Survivors
Official title: Harnessing the Effect of an Open-Label Placebo on Fatigue in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fatigue in Cancer Survivors
Keywords: Fatigue in Cancer Survivors
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2015-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale
timeFrame: Change from baseline to Day 8, and from baseline to Day 22
Secondary outcomes:
measure: Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF)
timeFrame: Change from baseline to Day 22
measure: Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale
timeFrame: Change from baseline to Day 22
measure: Subjective Sense of Change on fatigue, readiness for exercise and quality of life
timeFrame: Change from baseline to Day 8, and change from Baseline to Day 22
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Christopher Recklitis, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: