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

NCT04961320 | Withdrawn DMC

• 3 other identifiers: 20566NCI-2021-05561P30CA033572
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Pain ratings

  Baseline up to 5 and 12 weeks

• Depression

  From baseline to 5 and 12 weeks

• Anxiety

  From baseline to 5 and 12 weeks

• Fatigue Inventory Score

  At 12 weeks

Study Arms (1)

Supportive care (OT, questionnaires)

EXPERIMENTAL

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.

Behavioral: Occupational Therapy; Other: Questionnaire Administration

Interventions

Occupational Therapy BEHAVIORAL

Participate in OT session

Also known as: OT

Supportive care (OT, questionnaires)

Questionnaire Administration OTHER

Complete questionnaires

Supportive care (OT, questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Sumanta K Pal

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 14, 2021
• Study Start: July 15, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 9, 2022

Record last verified: 2022-06