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EMBRACE: Exercising Together

Primary Purpose

Breast Carcinoma, Prostate Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Biospecimen Collection
Educational Intervention
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: INTERVENTION (SURVIVORS) INCLUSION Histologically confirmed prostate cancer or breast cancer without evidence of metastatic disease Confirmed by review of the electronic medical record (EMR) and subsequently recorded in Case Report Form - Survivor Health History. In cases where the EMR isn't clear, their Oregon Health & Science University (OHSU) provider will be contacted for confirmation Scheduled to receive radiation therapy for curative intent at OHSU Confirmed by review of the EMR and subsequently recorded in Case Report Form - Survivor Health History. In cases where the EMR isn't clear, their OHSU provider will be contacted for confirmation Co-residing with an intimate partner or spouse who is willing to participate Confirmed by self-report on the Demographic Questionnaire INTERVENTION (SURVIVORS AND PARTNERS) INCLUSION 18 years of age and older For survivors: confirmed by review of the date of birth as documented in the Electronic Medical Record (EMR) and subsequently recorded in a case report form (CRF) For partners: confirmed by self-report on the Health History Questionnaire < 2 structured strength training sessions per week in the last month Confirmed by self-report on Health History Questionnaire Home internet sufficient for videoconferencing Confirmed by staff review of Internet Connectivity Screening Guide with the participants and outcome recorded in a CRF Signed informed consent Confirmed by completion of e-Consent in REDCap IMPLEMENTATION INCLUSION Be one of these key stakeholders: patient, spouse/partner, healthcare providers, or administrator Verbal informed consent following review of an Information Sheet Exclusion Criteria: INTERVENTION (SURVIVORS AND PARTNERS) EXCLUSION Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent Confirmed by mini-mental state exam (score < 21) or professional opinion of the principal investigator, Kerri Winters-Stone A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise. Specific contraindications include the following: poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, inability to ambulate without an assistive device, inability to stand for 3 minutes, severe hearing or vision problem Confirmed by a combination of reviewing the EMR, self-report on the Health History Questionnaire, Charlson Comorbidity Index questionnaire, and/or by physician clearance. If in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (Exercise Together exercise program)

Arm II (educational material)

Arm Description

Patients and partners undergo Exercising Together exercise program during radiation therapy on study. Patients also undergo collection of blood samples throughout the trial.

Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples throughout the trial.

Outcomes

Primary Outcome Measures

Physical functioning
Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and usual pace gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.
Anxiety
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) anxiety short form using questions on a scale ranging from 1 (never) to 5 (always).

Secondary Outcome Measures

Changes in patient-reported symptoms
Measured by PROMIS to assess symptoms of physical and mental health and global health (QoL). We will use the 13-item measure and 8-item measures for symptoms in the past 7 days. Global health is assessed with a 10-item measure that asks about physical, mental and social functioning.
Sleep Behavior: total sleep time
Measured using ActiGraph Link, we will have extended wear time to measures total sleep time over a 3-day monitoring period.
Inflammation - high sensitivity C-Reactive Protein (hsCRP)
Measured using a self-administered dried blood spot (DBS) collection kit. Participants are taught by research staff and follow a YouTube video to use a finger stick poke to obtain a drop of blood that is put onto a sample card. DBS captured on the designated card are dried thoroughly (> 4 hours at room temperature), then inserted into a foil pouch with desiccant and mailed to the research team. Cards are frozen (0 degree Fahrenheit [F] or below) until analyzed.

Full Information

First Posted
September 11, 2023
Last Updated
September 19, 2023
Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT06049355
Brief Title
EMBRACE: Exercising Together
Official Title
EMBark on RAdiation Therapy With a Clinic-based Exercise Program: EXERCISING TOGETHER
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
June 30, 2028 (Anticipated)
Study Completion Date
September 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Oregon Health and Science University, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This phase II trial tests how well an exercise intervention, Exercising Together, works in preventing declines in physical and mental health in couples during radiation treatment for cancer. Treatments for cancer can cause side effects such as fatigue as well as strain on relationships. Exercising Together is a partnered exercise program that adds communication, collaboration and support between partners during exercise to fortify the relationship and amplify the benefits of physical training. Exercising Together program may be effective on the mental and physical health of couples during radiation treatment for cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To test the effectiveness and mechanisms of the adapted Exercise Together intervention on mental and physical health of couples (Aims 1 & 2). SECONDARY OBJECTIVE: I. To gain better understanding of the implementation context and implementation outcomes (Aim 3). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients and partners undergo Exercising Together exercise program during radiation therapy on study. Patients also undergo collection of blood samples throughout the trial. ARM II: Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples throughout the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Prostate Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Exercise Together exercise program)
Arm Type
Experimental
Arm Description
Patients and partners undergo Exercising Together exercise program during radiation therapy on study. Patients also undergo collection of blood samples throughout the trial.
Arm Title
Arm II (educational material)
Arm Type
Active Comparator
Arm Description
Patients and partners receive educational materials specific to exercise. Patients also undergo collection of blood samples throughout the trial.
Intervention Type
Other
Intervention Name(s)
Exercise Intervention
Intervention Description
Undergo Exercise Together exercise program
Intervention Type
Procedure
Intervention Name(s)
Biospecimen Collection
Other Intervention Name(s)
Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Intervention Description
Undergo collection of blood samples
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Receive educational materials
Primary Outcome Measure Information:
Title
Physical functioning
Description
Measured by the Physical Performance Battery (PPB) to determine a person's ability to perform daily tasks independently. The PPB consists of 3 timed tests: 5 repeated chair stands, standing balance, and usual pace gait speed over 4 meters. Each test is scored 0 (unable) to 4 (completes without difficulty), based on quartiles of performance, then scores are summed. The possible range of scores is 0-12.
Time Frame
Up to 6 months
Title
Anxiety
Description
Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) anxiety short form using questions on a scale ranging from 1 (never) to 5 (always).
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Changes in patient-reported symptoms
Description
Measured by PROMIS to assess symptoms of physical and mental health and global health (QoL). We will use the 13-item measure and 8-item measures for symptoms in the past 7 days. Global health is assessed with a 10-item measure that asks about physical, mental and social functioning.
Time Frame
Up to 6 months
Title
Sleep Behavior: total sleep time
Description
Measured using ActiGraph Link, we will have extended wear time to measures total sleep time over a 3-day monitoring period.
Time Frame
Up to 6 months
Title
Inflammation - high sensitivity C-Reactive Protein (hsCRP)
Description
Measured using a self-administered dried blood spot (DBS) collection kit. Participants are taught by research staff and follow a YouTube video to use a finger stick poke to obtain a drop of blood that is put onto a sample card. DBS captured on the designated card are dried thoroughly (> 4 hours at room temperature), then inserted into a foil pouch with desiccant and mailed to the research team. Cards are frozen (0 degree Fahrenheit [F] or below) until analyzed.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: INTERVENTION (SURVIVORS) INCLUSION Histologically confirmed prostate cancer or breast cancer without evidence of metastatic disease Confirmed by review of the electronic medical record (EMR) and subsequently recorded in Case Report Form - Survivor Health History. In cases where the EMR isn't clear, their Oregon Health & Science University (OHSU) provider will be contacted for confirmation Scheduled to receive radiation therapy for curative intent at OHSU Confirmed by review of the EMR and subsequently recorded in Case Report Form - Survivor Health History. In cases where the EMR isn't clear, their OHSU provider will be contacted for confirmation Co-residing with an intimate partner or spouse who is willing to participate Confirmed by self-report on the Demographic Questionnaire INTERVENTION (SURVIVORS AND PARTNERS) INCLUSION 18 years of age and older For survivors: confirmed by review of the date of birth as documented in the Electronic Medical Record (EMR) and subsequently recorded in a case report form (CRF) For partners: confirmed by self-report on the Health History Questionnaire < 2 structured strength training sessions per week in the last month Confirmed by self-report on Health History Questionnaire Home internet sufficient for videoconferencing Confirmed by staff review of Internet Connectivity Screening Guide with the participants and outcome recorded in a CRF Signed informed consent Confirmed by completion of e-Consent in REDCap IMPLEMENTATION INCLUSION Be one of these key stakeholders: patient, spouse/partner, healthcare providers, or administrator Verbal informed consent following review of an Information Sheet Exclusion Criteria: INTERVENTION (SURVIVORS AND PARTNERS) EXCLUSION Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent Confirmed by mini-mental state exam (score < 21) or professional opinion of the principal investigator, Kerri Winters-Stone A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise. Specific contraindications include the following: poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, inability to ambulate without an assistive device, inability to stand for 3 minutes, severe hearing or vision problem Confirmed by a combination of reviewing the EMR, self-report on the Health History Questionnaire, Charlson Comorbidity Index questionnaire, and/or by physician clearance. If in the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone, contraindications other than those identified by the patient or physician are present, she may consider the participant ineligible
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Guidarelli
Phone
503-494-0444
Email
exercise@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Winters-Stone
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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EMBRACE: Exercising Together

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