Expressive Writing for the Management of Stress in Cancer Survivors

NCT04776941 | Recruiting

• 2 other identifiers: 2020-0538NCI-2021-00218
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (3)

• Participant response rate

  1 month

• Study completion rate

  1 month

• Intervention adherence rate

  1 month

Secondary Outcomes (4)

• Change in stress

  Baseline and 1-, 3-, and 6-month follow-up

• Change in quality of life

  Baseline and 1-, 3-, and 6-month follow-up

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

  Baseline and 1-, 3-, and 6-month follow-up

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

  Baseline and 1-, 3-, and 6-month follow-up

Study Arms (2)

Arm I (questionnaires, messages, writing)

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (questionnaires, messages, writing)

ACTIVE COMPARATOR

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.

Behavioral: Behavioral Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Read positive messages

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Arm I (questionnaires, messages, writing)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (questionnaires, messages, writing); Arm II (questionnaires, messages, writing)

Questionnaire Administration OTHER

Complete questionnaires

Arm I (questionnaires, messages, writing); Arm II (questionnaires, messages, writing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Qian Lu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian LU, MD,PHD

CONTACT

713-745-8324; qlu@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: March 2, 2021
• Study Start: August 7, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

US (1)