Expressive Writing for the Management of Stress in Cancer Survivors

COVID-19: A Virtual Feasibility Study to Manage Stress

This clinical trial evaluates the effect of expressive writing for the management of stress in cancer survivors. Cancer diagnosis and treatment are associated with increased stress in cancer survivors related to concerns about family, career, relationships, finances, side effects of treatment, and death. This stress can be further exacerbated by social upheavals such as the COVID-19 pandemic. For safety reasons, many patients are isolated with restricted access to in-person health care and reduced social interaction with family and friends. Together with the economic uncertainties that come with this pandemic, these factors are likely to increase cancer survivors' stress levels. Expressive writing may provide a medium through which cancer survivors confront stressors and find meaning in their experience. The goal of this trial is to learn more about the experiences of cancer survivors during stressful times.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention; Behavioral: Behavioral Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of the virtual study for cancer survivors. II. To preliminarily assess the impact of the intervention for cancer survivors.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (INTERVENTION): 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) once weekly (QW) for 3 weeks.

ARM II (CONTROL): 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.

• Study Type: Interventional
• Enrollment (Estimated): 414
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian LU, MD,PHD; Phone Number: 713-745-8324; Email: qlu@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Qian Lu; Phone Number: 713-745-8324; Email: qlu@mdanderson.org
      • Principal Investigator: Qian Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years old
• Have a diagnosis of cancer within the past 3 years
• Are able to speak and read in English
• Have access to a computer or smart phone with internet connection
• All disease sites and all cancer stages are eligible for enrollment

Exclusion Criteria:

• Inability to provide informed consent
• Non-English speakers will be excluded because this is a feasibility study that will enroll only a limited number of participants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (questionnaires, messages, writing); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Complete questionnaires; Behavioral: Behavioral Intervention; Read positive messages; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Write about positive experiences; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Write about neutral topics; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Read neutral messages; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments
Active Comparator: Arm II (questionnaires, messages, writing); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Questionnaire Administration; Complete questionnaires; Behavioral: Behavioral Intervention; Read positive messages; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Write about positive experiences; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Write about neutral topics; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Behavioral Intervention; Read neutral messages; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participant response rate	1 month
Study completion rate	1 month
Intervention adherence rate	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in stress	Perceived stress will be measured with the 4-item Perceived Stress Scale. Scale scores range from 0-16, with low scores indicating low perceived stress and high scores indicating high perceived stress	Baseline and 1-, 3-, and 6-month follow-up
Change in quality of life	Quality of life will be measured with the 7-item Functional Assessment of Cancer Therapy (FACT-G7). The items are rated on a 5-point scale from 0 - "not at all", to 4 - "very much". Scores range from 0-28, with higher scores indicating better quality of life.	Baseline and 1-, 3-, and 6-month follow-up
Change in physical health (sleep, fatigue, and cancer related morbidities)	Sleep will be measured with the 19-item Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with a cut-off score of 5 or greater indicating poor sleep quality. Fatigue will be measured with the 4-item PROMIS Fatigue Short Form. This measure assesses the magnitude of fatigue in the past 7 days. Items are measured on a five-point scale (1= "not at all"; 5 = "very much") and summed. Higher scores indicate greater fatigue. Cancer related morbidities will be self-reported by participants and verified through medical record review. .	Baseline and 1-, 3-, and 6-month follow-up
Change in psychological health (depressive symptoms, anxiety, and fear of cancer recurrence)	Depressive symptoms will be measured with the 4-item PROMIS Depression Short Form. This measure assesses the frequency of depressive symptoms in the past 7 days. Items are measured on a five-point scale (1= "never"; 5 = "always") and summed. Higher scores indicate more depressive symptoms. Anxiety will be measured with the 4-item PROMIS Anxiety Short Form. This measure assesses the frequency of anxiety in the past 7 days. Items are measured on a five-point scale (1= "never"; 5 = "always") and summed. Higher scores indicate greater anxiety. Fear of cancer recurrence will be measured with a single item added to the quality of life measure (F	Baseline and 1-, 3-, and 6-month follow-up

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Qian Lu, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: 2020-0538 (Other Identifier: M D Anderson Cancer Center); NCI-2021-00218 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No