Expressive Writing for the Management of Stress in Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Behavioral Intervention
BehavioralRead positive messages
Behavioral Intervention
BehavioralWrite about positive experiences
Behavioral Intervention
BehavioralWrite about neutral topics
Behavioral Intervention
BehavioralRead neutral messages
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionComplete questionnaires
Treatment groups
414 Participants
are divided into 2 treatment groupsGroup A: Arm I (questionnaires, messages, writing)Experimental treatment 3 interventions
Group B: Arm II (questionnaires, messages, writing)Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
Participant response rate
Time frame
1 month2
Study completion rate
Time frame
1 month3
Intervention adherence rate
Time frame
1 monthSecondary outcomes
1
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
Time frame
Baseline and 1-, 3-, and 6-month follow-up2
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.
Time frame
Baseline and 1-, 3-, and 6-month follow-up3
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. .
Time frame
Baseline and 1-, 3-, and 6-month follow-up4
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
Time frame
Baseline and 1-, 3-, and 6-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov