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

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

Must not have

Treatment for any other diagnosis of cancer within the previous 5 years

Cognitive or mental status affecting ability to follow directions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not been treated for any cancer other than NSCLC in the past 5 years.

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I can follow directions without any mental difficulties.

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My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met