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NCT Number: NCT04776941

Expressive Writing for the Management of Stress in Cancer Survivors

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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location status: Recruiting

Location contact

Qian Lu

CONTACT

[email protected]

713-745-8324

Qian Lu

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

behavioral intervention

Behavioral

Read positive messages

Other names: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Participant response rate

    Time frame: 1 month

  2. Study completion rate

    Time frame: 1 month

  3. Intervention adherence rate

    Time frame: 1 month

Secondary outcomes

  1. Change in stress

    Time frame: Baseline and 1-, 3-, and 6-month follow-up

    Perceived stress will be measured with the 4-item Perceived Stress Scale. Scale scores range from 0-16, with low scores indicating low perceived stress and high scores indicating high perceived stress

  2. Change in quality of life

    Time frame: Baseline and 1-, 3-, and 6-month follow-up

    Quality of life will be measured with the 7-item Functional Assessment of Cancer Therapy (FACT-G7). The items are rated on a 5-point scale from 0 - "not at all", to 4 - "very much". Scores range from 0-28, with higher scores indicating better quality of life.

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

    Time frame: Baseline and 1-, 3-, and 6-month follow-up

    Sleep will be measured with the 19-item Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, with a cut-off score of 5 or greater indicating poor sleep quality.

    Fatigue will be measured with the 4-item PROMIS Fatigue Short Form. This measure assesses the magnitude of fatigue in the past 7 days. Items are measured on a five-point scale (1= "not at all"; 5 = "very much") and summed. Higher scores indicate greater fatigue.

    Cancer related morbidities will be self-reported by participants and verified through medical record review.

    .

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

    Time frame: Baseline and 1-, 3-, and 6-month follow-up

    Depressive symptoms will be measured with the 4-item PROMIS Depression Short Form. This measure assesses the frequency of depressive symptoms in the past 7 days. Items are measured on a five-point scale (1= "never"; 5 = "always") and summed. Higher scores indicate more depressive symptoms.

    Anxiety will be measured with the 4-item PROMIS Anxiety Short Form. This measure assesses the frequency of anxiety in the past 7 days. Items are measured on a five-point scale (1= "never"; 5 = "always") and summed. Higher scores indicate greater anxiety.

    Fear of cancer recurrence will be measured with a single item added to the quality of life measure (F

Study contacts

Contact information is provided by the study sponsor or research team.

Qian LU, MD,PHD

CONTACT

[email protected]

713-745-8324

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

COVID-19: A Virtual Feasibility Study to Manage Stress

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Mar 2, 2021
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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