Occupational Therapy Fatigue Management-Based Intervention for Metastatic Renal Cell Carcinoma
June 7, 2022 updated by: City of Hope Medical Center
Assessing Efficacy of an Occupational Therapy Fatigue Management-Based Intervention for Patients With Metastatic Renal Cell Carcinoma
This clinical trial studies the effects of occupational therapy fatigue management in patients with renal cell cancer that has spread to other places in the body (metastatic).
Many patients diagnosed with cancer experience cancer-related fatigue.
These patients that are also on immunotherapy can experience added distressing fatigue that impacts their daily lives.
Occupational therapy uses a client-centered and holistic approach to work collaboratively with patients to assess fatigue and develop strategies to manage each individual's specific needs.
Fatigue-based management is a fundamental component of occupational therapy rehabilitation regimens.
This trial may help patients address and reduce their fatigue.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To determine if an occupational therapy (OT)-based intervention can reduce cancer-related fatigue by 10 percent as measured by the brief fatigue inventory (BFI) tool, in patients undergoing immunotherapy for metastatic renal cell carcinoma.
SECONDARY OBJECTIVES:
I. To determine if an OT-based intervention can improve pain ratings. II. To determine if an OT-based intervention can improve indices of depression. III. To determine if an OT-based intervention can improve indices of anxiety. IV. To determine if an OT-based intervention can maintain a reduced level of fatigue beyond the period of intervention.
OUTLINE:
Patients participate in OT sessions weekly for 3 weeks over 30 minutes each. Patients also complete questionnaires to assess anxiety, depression, fatigue and pain at baseline, 5 and 12 weeks.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18 and over.
- Sufficiently fluent in English.
- Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC).
- Evidence of metastatic disease.
- Clinician assessed prognosis of greater than or equal to six months.
- Patients who are undergoing immunotherapy treatment (with a checkpoint inhibitor) for advanced kidney cancer who have grade 1 or 2 fatigue based on physician assessment at the time of study entry.
- Willing and independently able to provide consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive care (OT, questionnaires)
Patients participate in OT sessions weekly for 3 weeks over 30 minutes each.
Patients also complete questionnaires to assess anxiety, depression, fatigue and pain at baseline, 5 and 12 weeks.
|
Complete questionnaires
Participate in OT session
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue Inventory Score
Time Frame: Baseline up to 5 weeks
|
Percentage of patients with a 10 percent or greater reduction in brief fatigue inventory score. Brief Fatigue Inventory is scored on an 10 points scale (0 to 10), with higher scores indicating worse outcomes. |
Baseline up to 5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain ratings
Time Frame: Baseline up to 5 and 12 weeks
|
Pairwise differences of score will be calculated for the PAIN assessment tools per patient, between baseline and the follow-up time points of 5 and 12 weeks.
Descriptive statistics will be used to summarize the change in pain score, (from baseline to 5- and 12- weeks).
Plots will be utilized to help visualize the changes in scores over time.
The scale for the PAIN tool ranges 0-10, with the higher scores indicating worse outcomes.
|
Baseline up to 5 and 12 weeks
|
|
Depression
Time Frame: From baseline to 5 and 12 weeks
|
Pairwise differences of score will be calculated for the Depression assessment tool per patient, between baseline and the follow-up time points of 5 and 12 weeks.
Descriptive statistics will be used to summarize the change in the PROMIS Depression score, (from baseline to 5- and 12- weeks).
Plots will be utilized to help visualize the changes in Depression scores over time.
Total score for the PROMIS Depression tool ranges from 8 to 40, with higher scores indicating worse outcomes.
|
From baseline to 5 and 12 weeks
|
|
Anxiety
Time Frame: From baseline to 5 and 12 weeks
|
Pairwise differences of score will be calculated for the PROMIS Anxiety tool per patient, between baseline and the follow-up time points of 5 and 12 weeks.
Descriptive statistics will be used to summarize the change in the anxiety score, indices of anxiety and depression, and fatigue score (from baseline to 5- and 12- weeks).
Plots will be utilized to help visualize the changes in anxiety scores over time.
The total possible score for the PROMIS for the PROMIS for the PROMIS Anxiety tool ranges from 7 to 35, with higher scores indicating worse outcomes.
|
From baseline to 5 and 12 weeks
|
|
Fatigue Inventory Score
Time Frame: At 12 weeks
|
Percentage of patients with a 10 percent or greater reduction in brief fatigue inventory score.
Fatigue is scored on an 10 points scale (0 to 10), with higher scores indicating worse outcomes.
|
At 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 15, 2022
Primary Completion (Anticipated)
June 1, 2024
Study Completion (Anticipated)
June 1, 2024
Study Registration Dates
First Submitted
June 11, 2021
First Submitted That Met QC Criteria
July 10, 2021
First Posted (Actual)
July 14, 2021
Study Record Updates
Last Update Posted (Actual)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 7, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20566 (Other Identifier: City of Hope Medical Center)
- P30CA033572 (U.S. NIH Grant/Contract)
- NCI-2021-05561 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.