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Expressive Writing for Cancer Stress Management

N/A

Recruiting

Led By Qian Lu

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

At least 18 years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1-, 3-, and 6-month follow-up

Awards & highlights

Study Summary

This trial is testing whether expressive writing can help manage stress in cancer survivors.

Who is the study for?

This trial is for cancer survivors who are at least 18 years old, diagnosed within the last 3 years, and can read and speak English. Participants need internet access via a computer or smartphone. All types of cancers and stages are welcome, but those unable to consent or non-English speakers cannot join.Check my eligibility

What is being tested?

The study looks at how expressive writing might help manage stress in people who have survived cancer. It aims to understand their experiences during stressful events like the COVID-19 pandemic when isolation and economic uncertainty may increase stress levels.See study design

What are the potential side effects?

Since this intervention involves questionnaire administration, quality-of-life assessment, and behavioral intervention through writing, there are no direct medical side effects; however, participants may experience emotional discomfort while reflecting on stressful experiences.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1-, 3-, and 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1-, 3-, and 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1-, 3-, and 6-month follow-up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Intervention adherence rate

Participant response rate

Study completion rate

Secondary outcome measures

Change in physical health (sleep, fatigue, and cancer related morbidities)

Change in psychological health (depressive symptoms, anxiety, and fear of cancer recurrence)

Change in quality of life

+1 more

Side effects data

From 2013 Phase 1 & 2 trial • 16 Patients • NCT01923896

13%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Behavioral Intervention & DCS

Behavioral Intervention & Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (questionnaires, messages, writing)Experimental Treatment3 Interventions

Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief positive messages and write essays about their experiences over 30 minutes (non-stop) QW for 3 weeks.

Group II: Arm II (questionnaires, messages, writing)Active Control3 Interventions

Patients complete questionnaires over 30 minutes about their mood, health, and income at baseline, and 1, 3, and 6 months. Patients also read brief neutral messages and write essays about neutral topics over 30 minutes (non-stop) QW for 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention

2021

Completed Phase 4

~3740

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,201 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,785 Total Patients Enrolled

1 Trials studying Blood Cancers

70 Patients Enrolled for Blood Cancers

Qian LuPrincipal InvestigatorM.D. Anderson Cancer Center

3 Previous Clinical Trials

1,544 Total Patients Enrolled

Media Library

Expressive Writing 2023 Treatment Timeline for Medical Study. Trial Name: NCT04776941 — N/A

Frequently Asked Questions

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

Is this trial still open to new participants?

"Confirmed; clinicaltrials.gov displays that this medical study is actively seeking participants since its original posting on August 7th 2020 and most recent update from May 26th 2022."

Answered by AI

What objectives are being sought through this experiment?

"The primary outcome to be assessed over the span of one month will gauge participants' adherence rate with the intervention. Secondary objectives include gauging changes in physical health (e.g., sleep, fatigue, and cancer-related ailments) as well as psychological health (depressive symptoms, anxiety levels, etc.) and quality of life using various measures such as Pittsburgh Sleep Quality Index (PSQI), PROMIS Fatigue Short Form & Depression/Anxiety Short Forms, and Functional Assessment of Cancer Therapy - General 7 Scale (FACT-G7)."

Answered by AI

How many individuals have been recruited to participate in this experiment?

"Affirmative, the research project is actively searching for enrollees. This trial was first advertised on August 7th 2020 and has been updated with new information as recently as May 26th 2022. The current goal is to enlist 120 individuals from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Expressive Writing for the Management of Stress in Cancer Survivors

2020. "Expressive Writing for the Management of Stress in Cancer Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04776941.