Clinical trial NCT04776941: Expressive Writing for the Management of Stress in Cancer Survivors
Official title: COVID-19: A Virtual Feasibility Study to Manage Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-03-02
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Participant response rate
timeFrame: 1 month
measure: Study completion rate
timeFrame: 1 month
measure: Intervention adherence rate
timeFrame: 1 month
Secondary outcomes:
measure: Change in stress
timeFrame: Baseline and 1-, 3-, and 6-month follow-up
measure: Change in quality of life
timeFrame: Baseline and 1-, 3-, and 6-month follow-up
measure: Change in physical health (sleep, fatigue, and cancer related morbidities)
timeFrame: Baseline and 1-, 3-, and 6-month follow-up
measure: Change in psychological health (depressive symptoms, anxiety, and fear of cancer recurrence)
timeFrame: Baseline and 1-, 3-, and 6-month follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Qian Lu
role: PRINCIPAL_INVESTIGATOR
References: