RecruitingInterventional

COVID-19: A Virtual Feasibility Study to Manage Stress

NCT ID: NCT04776941Sponsor: M.D. Anderson Cancer CenterLast updated: 2026-06-02

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.

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.

Arms & interventions

BehavioralBehavioral Intervention
Read positive messages
BehavioralBehavioral Intervention
Write about positive experiences
BehavioralBehavioral Intervention
Write about neutral topics
BehavioralBehavioral Intervention
Read neutral messages
OtherQuality-of-Life Assessment
Ancillary studies
OtherQuestionnaire Administration
Complete questionnaires

Outcome measures

Primary

Participant response rate
Time frame: 1 month
Study completion rate
Time frame: 1 month
Intervention adherence rate
Time frame: 1 month

Secondary

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

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

M D Anderson Cancer Center

Houston, Texas, 77030

Recruiting

Qian Lu · Contact

713-745-8324 qlu@mdanderson.org

Qian Lu · Principal Investigator

References

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.(PubMed)