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Guided Relaxation Training for Breast Cancer (09-IM-01 Trial)

Q: Am I eligible for enrollment in this research project?

This trial, which will span 18 weeks from recruitment to follow-up, is seeking 40 <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a> patients aged between majority and 75. In order to qualify for the study, participants must also meet additional criteria: undergoing chemotherapy or radiation therapy; readiness to complete the CSES, PSS-14 and FACIT-F scales; access to a CD player; score 4/10+ on Visual Analog Scale for stress levels; ability to travel weekly for guided relaxation sessions at cancer centers.

Q: Does this research trial currently have open enrollment?

According to clinicaltrials.gov, this medical experiment has concluded recruitment and is not accepting participants at present. The trial was posted on July 1st 2009 and last updated two years later in 2011. It must be noted that there are a plethora of studies recruiting patients right now with 2602 currently active trials available worldwide.

Q: Are geriatric patients eligible to partake in this research?

Individuals that meet the inclusion criteria for this study must be over 18 and below 75 years of age.

Phase < 1

Waitlist Available

Led By Carol S Blecher, RN, MS, AOCN, APNC

Research Sponsored by Trinitas Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At or between the ages of 18 and 75

Ability to travel to cancer center weekly specifically for on-site guided relaxation training sessions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end point

Awards & highlights

09-IM-01 Trial Summary

This trial aims to see if Guided Relaxation Training can help people with newly diagnosed breast cancer to cope better and feel less stressed.

Who is the study for?

This trial is for individuals aged 18-75 with newly diagnosed breast cancer who can speak English, travel weekly to a cancer center, and commit to an 18-week study. They must be able to use a CD player and have some stress related to their diagnosis. Those with brain metastasis, prior complementary therapies for cancer (except herbal supplements), cognitive impairments, or other recent cancers are excluded.Check my eligibility

What is being tested?

The trial tests if Guided Relaxation Training (GRT) helps people cope better and feel less stressed during breast cancer treatment. Participants will use GRT sessions on-site at the cancer center and complete various scales measuring coping ability and perceived stress over the course of the study.See study design

What are the potential side effects?

Since this intervention involves relaxation training rather than medication or invasive procedures, significant side effects are not expected. However, participants may experience varying levels of comfort or emotional response when engaging in relaxation techniques.

09-IM-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I can travel to the cancer center every week for relaxation training.

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I am expected to undergo chemotherapy and/or radiation.

09-IM-01 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ endpoint

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~endpoint

This trial's timeline: 3 weeks for screening, Varies for treatment, and endpoint for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer increases their coping ability.

Determining if the use of GRT during treatment in individuals newly diagnosed with breast cancer reduces their perceived stress.

Secondary outcome measures

Determining differences of perceived levels of stress among various racial and ethnic groups.

Determining the effects of GRT on vital signs and self-reported levels of fatigue.

09-IM-01 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Guided Relaxation TrainingExperimental Treatment1 Intervention

Eligible subjects who have been randomized to the intervention arm will be scheduled for GRT introduction and training with a research staff member. The GRT sessions will consist of six weekly on-site sessions in which the subject is provided instructions and then allowed to listen to the GRT CD. Subjects will be instructed to conduct independent GRT sessions at home, twice daily, at least four hours apart, for the duration of the study. Subjects will also be instructed that on the days of one-on-one sessions with a research staff member at TCCC, that they will only be required to perform the independent session once at home. Subjects will be provided with a diary to record the date and time of each independent GRT session performed at home. Subjects will be instructed to bring their completed diary with them at each subsequent visit.

Group II: Standard of Care(SOC)Active Control1 Intervention

Eligible subjects who are randomized to the SOC arm will not receive the GRT sessions. During the six week treatment phase, these subjects will only receive SOC provided to all subjects newly diagnosed with breast cancer at TCCC. This consists of an education session with the nurse or nurse practitioner. In addition, they will also be provided with supportive care and symptom management as needed. This arm will also be provided with a diary to record their stress level at least twice daily.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Trinitas Comprehensive Cancer CenterLead Sponsor

Aptium Oncology Research NetworkNETWORK

2 Previous Clinical Trials

92 Total Patients Enrolled

1 Trials studying Breast Cancer

30 Patients Enrolled for Breast Cancer

Carol S Blecher, RN, MS, AOCN, APNCPrincipal InvestigatorTrinitas Comprehensive Cancer Center

Media Library

Guided Relaxation Training Clinical Trial Eligibility Overview. Trial Name: NCT00945607 — Phase < 1

Breast Cancer Research Study Groups: Guided Relaxation Training, Standard of Care(SOC)

Breast Cancer Clinical Trial 2023: Guided Relaxation Training Highlights & Side Effects. Trial Name: NCT00945607 — Phase < 1

Guided Relaxation Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT00945607 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible for enrollment in this research project?

"This trial, which will span 18 weeks from recruitment to follow-up, is seeking 40 breast cancer patients aged between majority and 75. In order to qualify for the study, participants must also meet additional criteria: undergoing chemotherapy or radiation therapy; readiness to complete the CSES, PSS-14 and FACIT-F scales; access to a CD player; score 4/10+ on Visual Analog Scale for stress levels; ability to travel weekly for guided relaxation sessions at cancer centers."

Answered by AI

Does this research trial currently have open enrollment?

"According to clinicaltrials.gov, this medical experiment has concluded recruitment and is not accepting participants at present. The trial was posted on July 1st 2009 and last updated two years later in 2011. It must be noted that there are a plethora of studies recruiting patients right now with 2602 currently active trials available worldwide."

Answered by AI