Expressive Writing for the Management of Stress in Cancer Survivors

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04776941

NCI-2021-00218 (Registry Identifier)

2020-0538 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 414 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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414 participants in 2 patient groups

Arm I (questionnaires, messages, writing)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Behavioral: Behavioral Intervention

Behavioral: Behavioral Intervention

Behavioral: Behavioral Intervention

Behavioral: Behavioral Intervention

Arm II (questionnaires, messages, writing)

Active Comparator group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Quality-of-Life Assessment

Behavioral: Behavioral Intervention

Behavioral: Behavioral Intervention

Behavioral: Behavioral Intervention

Behavioral: Behavioral Intervention