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Recruiting NCT04776941

Expressive Writing for the Management of Stress in Cancer Survivors

No phase Interventional Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral Intervention, Behavioral Intervention, Behavioral Intervention, Behavioral Intervention.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

COVID-19: A Virtual Feasibility Study to Manage Stress

Overview

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.

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.

Interventions

  • Behavioral Behavioral Intervention
    Read positive messages
  • Behavioral Behavioral Intervention
    Write about positive experiences
  • Behavioral Behavioral Intervention
    Write about neutral topics
  • Behavioral Behavioral Intervention
    Read neutral messages
  • Other Quality-of-Life Assessment
    Ancillary studies
  • Other Questionnaire Administration
    Complete questionnaires

Primary outcome measures

  • Participant response rate [Time frame: 1 month]
  • Study completion rate [Time frame: 1 month]
  • Intervention adherence rate [Time frame: 1 month]
Secondary outcome measures (4)
  • Change in stress [Time frame: Baseline and 1-, 3-, and 6-month follow-up]
  • Change in quality of life [Time frame: Baseline and 1-, 3-, and 6-month follow-up]
  • Change in physical health (sleep, fatigue, and cancer related morbidities) [Time frame: Baseline and 1-, 3-, and 6-month follow-up]
  • Change in psychological health (depressive symptoms, anxiety, and fear of cancer recurrence) [Time frame: Baseline and 1-, 3-, and 6-month follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • M D Anderson Cancer Center — Houston

Publications

  • Shin-Cho LJ, Dawkins-Moultin L, Choi E, Chen M, Barcenas CH, Roth M, Li Y, Lu Q. Feasibility Trial of an Online Expressive Writing Intervention for Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2025 Aug;14(4):328-336. doi: 10.1089/jayao.2023.0187. Epub 2024 Oct 28. PMID 39466058

Identifiers

NCT: NCT04776941 · 2020-0538 · NCI-2021-00218 · 2020-0538

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗