CanRestoreFunction Cancer-related Fatigue ( CRF )

NCT ID: NCT05868187

Last Updated: 2024-12-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Breast Neoplasm

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise, Problem-Solving and Education

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

Group Type EXPERIMENTAL

Exercise, Problem-Solving Session and Education

Intervention Type 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

Usual Care

Participants will complete their daily routines as they typically do.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise, Problem-Solving Session and Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Dayton

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Anne Fleischer

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Fleischer, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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HRP - 503

Identifier Type: -

Identifier Source: org_study_id