Clinical trial NCT04961320: Occupational Therapy Fatigue Management-Based Intervention for Metastatic Renal Cell Carcinoma
Official title: Assessing Efficacy of an Occupational Therapy Fatigue Management-Based Intervention for Patients With Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Metastatic Renal Cell Carcinoma
Stage IV Renal Cell Cancer AJCC v8
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-07-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Fatigue Inventory Score
timeFrame: Baseline up to 5 weeks
Secondary outcomes:
measure: Pain ratings
timeFrame: Baseline up to 5 and 12 weeks
measure: Depression
timeFrame: From baseline to 5 and 12 weeks
measure: Anxiety
timeFrame: From baseline to 5 and 12 weeks
measure: Fatigue Inventory Score
timeFrame: At 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: City of Hope Medical Center
name: Sumanta K Pal
role: PRINCIPAL_INVESTIGATOR
References: