CompletedNot Applicable

Mindfulness Relaxation Compared With Relaxing Music and Standard Symptom Management Education in Treating Patients Who Are Undergoing Chemotherapy For Newly Diagnosed Solid Tumors

United States474 participantsStarted 2004-06

Plain-language summary

RATIONALE: Mindfulness relaxation, a technique to help patients quiet their thoughts and relax their bodies before and during chemotherapy, may reduce or prevent nausea and vomiting. It may also help improve mental health, quality of life, and immune function in patients receiving chemotherapy. PURPOSE: This randomized clinical trial is studying mindfulness relaxation to see how well it works compared to relaxing music or standard symptom management education in treating patients who are receiving chemotherapy for newly diagnosed solid tumors.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. are \>/= 18 years of age
. are anticipated to undergo at least four cycles of chemotherapy treatment
. have had no previous treatment with chemotherapy
. have no evidence of distant metastatic disease
. can read/speak in English or Spanish
. have no known psychotic diagnosis
. have an expected survival of at least 6 months

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)

Timeframe: Up to 12 months post treatment

Distress as measured by Impact of Event Scale (IES)

Timeframe: Up to 12 months post treatment

Fatigue as measured by brief fatigue inventory (BFI)

Timeframe: Up to 12 months post treatment

Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)

Timeframe: Up to 12 months post treatment

Depression as measured by Center for Epidemiology-Depression (CES-D)

Timeframe: Up to 12 months post treatment

Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)

Timeframe: Up to 12 months post treatment

Pain as measured by brief pain inventory (BPI)

Timeframe: Up to 12 months post treatment

Trial details

NCT IDNCT00086762

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-11

View on ClinicalTrials.gov More Chemotherapy-induced Nausea and Vomiting trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. are \>/= 18 years of age
. are anticipated to undergo at least four cycles of chemotherapy treatment
. have had no previous treatment with chemotherapy
. have no evidence of distant metastatic disease
. can read/speak in English or Spanish
. have no known psychotic diagnosis
. have an expected survival of at least 6 months

Exclusion criteria

What they're measuring

Conditioned nausea and vomiting as measured by Morrow assessment of nausea and emesis (MANE)

Timeframe: Up to 12 months post treatment

Distress as measured by Impact of Event Scale (IES)

Timeframe: Up to 12 months post treatment

Fatigue as measured by brief fatigue inventory (BFI)

Timeframe: Up to 12 months post treatment

Anxiety as measured by Spielberger State/Trait Anxiety Scale (STAI)

Timeframe: Up to 12 months post treatment

Depression as measured by Center for Epidemiology-Depression (CES-D)

Timeframe: Up to 12 months post treatment

Sleep as measured by Pittsburgh Sleep Quality Index (PSQI)

Timeframe: Up to 12 months post treatment

Pain as measured by brief pain inventory (BPI)

Timeframe: Up to 12 months post treatment