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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Renal Cell Carcinoma Stage IV Renal Cell Cancer AJCC v8

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Occupational Therapy

Intervention Type BEHAVIORAL

Participate in OT session

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Occupational Therapy

Participate in OT session

Intervention Type BEHAVIORAL

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Other Intervention Names

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OT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No