Expressive Writing for the Management of Stress in Cancer Survivors

Malignant Solid Neoplasm Clinical Trial

Official title:

COVID-19: A Virtual Feasibility Study to Manage Stress

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04776941
• Other study ID #: 2020-0538
• Secondary ID: NCI-2021-0021820
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Behavioral:
• Behavioral Intervention
Read positive messages
• Behavioral Intervention
Write about positive experiences
• Behavioral Intervention
Write about neutral topics
• Behavioral Intervention
Read neutral messages

Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant response rate		1 month
Primary	Study completion rate		1 month
Primary	Intervention adherence rate		1 month
Secondary	Change in stress	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	Baseline and 1-, 3-, and 6-month follow-up
Secondary	Change in quality of life	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.	Baseline and 1-, 3-, and 6-month follow-up
Secondary	Change in physical health (sleep, fatigue, and cancer related morbidities)	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.; .	Baseline and 1-, 3-, and 6-month follow-up
Secondary	Change in psychological health (depressive symptoms, anxiety, and fear of cancer recurrence)	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	Baseline and 1-, 3-, and 6-month follow-up

External Links

•   MD Anderson Cancer Center