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

Primary Purpose

Fatigue in Cancer Survivors

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue in Cancer Survivors focused on measuring Fatigue in Cancer Survivors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Open-Label Placebo

NT-Control

Arm Description

- Placebo Tablets-Twice a day for 3-4 weeks

- No Placebo Tablets

Outcomes

Primary Outcome Measures

Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale
13-item self-report measure of fatigue

Secondary Outcome Measures

Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF)
35-items self-report mood scale
Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale
12-item HRQOL measure
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.

Full Information

First Posted
May 19, 2015
Last Updated
December 10, 2018
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02452710
Brief Title
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

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Study funding was completed.
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue in Cancer Survivors
Keywords
Fatigue in Cancer Survivors

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Placebo
Arm Type
Experimental
Arm Description
- Placebo Tablets-Twice a day for 3-4 weeks
Arm Title
NT-Control
Arm Type
No Intervention
Arm Description
- No Placebo Tablets
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Open-label placebo
Primary Outcome Measure Information:
Title
Change in Fatigue on the Functional Assessment of Cancer Therapy - Fatigue (FACIT-F) scale
Description
13-item self-report measure of fatigue
Time Frame
Change from baseline to Day 8, and from baseline to Day 22
Secondary Outcome Measure Information:
Title
Change in Mood on the Profile of Mood Scale- Short Form (POMS-SF)
Description
35-items self-report mood scale
Time Frame
Change from baseline to Day 22
Title
Health Related Quality of Life on the Short Form-12 (SF-12) quality of life scale
Description
12-item HRQOL measure
Time Frame
Change from baseline to Day 22
Title
Subjective Sense of Change on fatigue, readiness for exercise and quality of life
Description
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.
Time Frame
Change from baseline to Day 8, and change from Baseline to Day 22

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Recklitis, PhD, MPH
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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