Occupational Therapy Fatigue Management-Based Intervention for Metastatic Renal Cell Carcinoma

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• Status: Withdrawn
• Conditions: Metastatic Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Occupational Therapy

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

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.	Other: Questionnaire Administration; Complete questionnaires; Behavioral: Occupational Therapy; Participate in OT session; Other Names: OT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue Inventory Score	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	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	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	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	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

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

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: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• 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