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

City of Hope

Status: Withdrawn

Conditions: Metastatic Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8

Treatments: Other: Questionnaire Administration; Behavioral: Occupational Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04961320

P30CA033572 (U.S. NIH Grant/Contract)

NCI-2021-05561 (Registry Identifier)

20566 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive care (OT, questionnaires)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Behavioral: Occupational Therapy