CanRestoreFunction Cancer-related Fatigue ( CRF )

NCT05868187 | Completed

• 1 other identifier: HRP - 503
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized control trial is to determine if participating in an 8-week online cancer-related fatigue management intervention consisting of individualized exercise program, one-on-one goal setting and action plan development and interactive educational module will significantly reduce the perception of cancer-related fatigue, improve the quality of life, improve perceived cognition, and perceived function of breast cancer compared to a wait-list control group. The aim the project is to determine if an online cancerrelated fatigue management program is associated with 1. A decrease in cancer-related fatigue. 2. An improved perception of their ability and satisfaction in completing important activities 3. Greater quality of life. 4. Improved mobility 5. Improved perceived cognition

Conditions

Breast Neoplasm

Keywords

cancer-related fatigue; breast cancer; exercise; problem-solving; online interactive education

Outcome Measures

Primary Outcomes (3)

• Brief Fatigue Inventory

  This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale

  Baseline

• Brief Fatigue Inventory

  This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale

  4-week

• Brief Fatigue Inventory

  This 9-item scale assesses the severity and interference of fatigue based on a 0 (no fatigue) to 10 (greatest fatigue) scale

  8-week

Secondary Outcomes (34)

• Canadian Occupational Performance Measure

  Baseline

• Canadian Occupational Performance Measure

  4-week

• Canadian Occupational Performance Measure

  8-week

• Functional Assessment of Chronic Illness Therapy-Fatigue

  Baseline

• Functional Assessment of Chronic Illness Therapy-Fatigue

  4-weeks

Study Arms (2)

Exercise, Problem-Solving and Education

EXPERIMENTAL

Individualized exercise program Weekly Goals setting and problem-solving session to create a weekly action plan Four Assigned interactive educational modules

Behavioral: Exercise, Problem-Solving Session and Education

Usual Care

NO INTERVENTION

Participants will complete their daily routines as they typically do.

Interventions

Exercise, Problem-Solving Session and Education BEHAVIORAL

Complete assigned exercises three times a week Complete Action plan co-developed Complete part or all of one of the four interactive educational modules

Exercise, Problem-Solving and Education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• been diagnosed with any type of cancer within 5 years of enrollment,
• received chemotherapy and/or radiation therapy
• have access to mobile device or computer
• have basic computer or mobile device skills,
• have a significant level of fatigue defined as \>3 on 0-10 scale using the Oneitem Fatigue Scale

You may not qualify if:

• have metastatic cancer (Stage 4),
• do not have a signed medical release by their physician or physician extender indicating that the participant can safely participate in the exercise program,
• chronic fatigue prior to cancer diagnosis, such as fibromyalgia
• are unable to follow verbal or written assessment instructions, are non-English speaking

Sponsors & Collaborators

• University of Cincinnati: lead
• University of Dayton: collaborator

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Study Officials

• Anne Fleischer, Ph.D

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: May 22, 2023
• Study Start: March 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

US (1)